Health product recalls and alerts, 2022
551 notices, newest first. Each links to the official notice.
Drugs, vaccines and biologics
- 99.0 % Oxygen USP - Gas cylinders containing commercial grade oxygenDecember 22, 2022 · Drugs · Product quality · Type III
- 18F-Fludeoxyglucose (18F-FDG); Sterility concernsDecember 14, 2022 · Radiopharmaceuticals · Product quality · Type III
- Allergenic extract non pollens (Peanut allergy): False negative for skin testDecember 14, 2022 · Biologic or vaccine · Product quality · Type I
- COMIRNATY Original & Omicron BA.4/BA.5 Bivalent Vaccine with English-only Vial and Carton Labels: New Formulation for Use in Children 5 to Less Than 12 Years of AgeDecember 9, 2022 · Biologic or vaccine · Labelling - Packaging - Product safety - Supply - COVID
- NAT-Bendamustine: DiscolorationDecember 6, 2022 · Drugs · Product quality · Type II
- OCALIVA (obeticholic acid) – New Contraindication for the Treatment of Primary Biliary Cholangitis (PBC)December 5, 2022 · Drugs · New safety information
- Privigen: Series of adverse reactionsDecember 1, 2022 · Drugs · Adverse reaction · Type II
- Teva-Atenolol; Product label image incorrectNovember 21, 2022 · Drugs · Labelling · Type III
- SPIKEVAX Bivalent (Original / Omicron BA.4/5) (elasomeran/davesomeran) COVID-19 Vaccine with English-only Vial and Carton LabelsNovember 18, 2022 · Biologic or vaccine · Labelling - Packaging - Product safety - Supply - COVID
- Allergenic extract non pollens (Peanut allergy): False negative for skin testNovember 15, 2022 · Biologic or vaccine · Product quality · Type I
- Baxter Corporation; leaks of intravenous bagsNovember 3, 2022 · Health products · Product quality · Type I
- Canadian labelling for all JAK inhibitors to include risks of serious heart-related problems, fatal blood clots and cancerNovember 1, 2022 · Drugs · Labelling
- Janus Kinase Inhibitors and the Risk of Major Adverse Cardiovascular Events, Thrombosis (Including Fatal Events) and MalignancyOctober 31, 2022 · Drugs · New safety information - Product safety
- EVUSHELD (tixagevimab and cilgavimab for injection) - Risk of Prophylaxis or Treatment Failure due to Antiviral ResistanceOctober 26, 2022 · Biologic or vaccine · New safety information - Product safety - COVID
- POTASSIUM CHLORIDE IN LACTATED RINGER'S INJECTION: Affected lot is labelled with the incorrect strength and ingredientOctober 24, 2022 · Drugs · Labelling · Type I
- BOOSTRIX: Syringes may be cracked in affected lot.October 7, 2022 · Biologic or vaccine · Product quality · Type II
- COMIRNATY Original & Omicron BA.4/BA.5 Bivalent Vaccine with English-only Vial and Carton LabelsOctober 7, 2022 · Biologic or vaccine · Labelling - Packaging - Product safety - Supply - COVID
- Children’s ibuprofen/acetaminophen shortage: What you should know and doOctober 7, 2022 · Drugs · Supply
- Canadian Medicated Shampoo: Defective capOctober 4, 2022 · Veterinary drugs · Product quality · Type II
- Menopur: Potential for a future out of specification result during shelf lifeSeptember 28, 2022 · Drugs · Product quality · Type III
- Lumi Lash: Unlicensed product with ingredient on prescription drug list.September 26, 2022 · Drugs · Unauthorized product - Undeclared substance · Type II
- Riva-Oxazepam: Incorrect label (Riva-Oxazepam 30MG 500 tablets DIN00568414) may be appended to affected lots that contains: Riva-Oxazepam 15MG 500 tablets DIN00568406September 22, 2022 · Drugs · Labelling · Type II
- Venlafaxine: OOS result for Spheroids Dissolution Rate Profile (DRP)September 21, 2022 · Drugs · Product quality · Type II
- Esomeprazole, Candesartan and Pravastatin Tablets: OOS result for Finished Product Assay and/or Blend UniformitySeptember 21, 2022 · Drugs · Product quality · Type II
- ZOLGENSMA (onasemnogene abeparvovec) and Fatal Cases of Acute Liver FailureSeptember 12, 2022 · Biologic or vaccine · New safety information
- COMIRNATY (COVID-19 Vaccine, mRNA, also referred to as Pfizer-BioNTech COVID-19 Vaccine): New Presentation for Use in Children Aged 6 Months to Less Than 5 Years with English-only Vial and Carton LabelsSeptember 9, 2022 · Biologic or vaccine · Packaging - Product safety - Supply
- Counterfeit Nuceiva injectable drug seized from New You Spa in Vaughan, OntarioSeptember 6, 2022 · Drugs · Product safety - Unauthorized product
- Quetiapine 25 mg: The affected lot (quetiapine 25 mg) may contain sertraline 50 mg tablets.September 2, 2022 · Drugs · Health products · Type II
- Distribution of SPIKEVAX Bivalent (elasomeran/imelasomeran) COVID-19 Vaccine with English-only Vial and Carton LabelsSeptember 2, 2022 · Biologic or vaccine · Labelling - Packaging - Product safety - COVID
- Menopur: Out of specification (Assay)August 31, 2022 · Drugs · Product quality · Type III
- DRAXIMAGE MDP: Affected lot may contain particulate matterAugust 30, 2022 · Radiopharmaceuticals · Product quality · Type I
- NERFASIN 20: Affected lot may contain the presence of particlesAugust 29, 2022 · Veterinary drugs · Product quality · Type I
- JAMP ATORVASTATIN CALCIUM: Affected lot may be labelled with the incorrect strength on the label.August 29, 2022 · Drugs · Dosage - Labelling · Type I
- IMBRUVICA (ibrutinib) - Risk of Serious and Fatal Cardiac Arrhythmias or Cardiac FailureAugust 29, 2022 · Drugs · New safety information - Product safety
- Recall of one lot of Jamp-Atorvastatin Calcium as some bottles may be labelled as containing 10 mg tablets, but contain 40 mg tabletsAugust 27, 2022 · Drugs · Dosage - Labelling
- Counterfeit Viagra and Cialis erectile dysfunction drugs seized from Grace Daily Mart in Scarborough, OntarioAugust 25, 2022 · Drugs · Product safety
- Jamp-Vitamin D: Out of SpecificationAugust 22, 2022 · Drugs · Product quality · Type II
- PMS-Hydromorphone: Affected lot may contain tablets that could potentially lead to overdoseAugust 22, 2022 · Drugs · Adverse reaction - Dosage - Labelling - Packaging - Product safety - Product withdrawal · Type I
- Recall of one lot of pms-Hydromorphone due to packaging error that could potentially lead to overdoseAugust 20, 2022 · Drugs · Adverse reaction - Dosage - Labelling - Packaging - Product safety - Product withdrawal
- Taro-Zoledronic Acid: The affected lots may contain particulate matterAugust 10, 2022 · Drugs · Product quality · Type I
- Taro-Zoledronic acid injection drug, used for osteoporosis and Page's disease, recalled because it may contain particulate matterAugust 9, 2022 · Drugs · Product quality
- JAMP-ATORVASTATIN: The affected lot may contain latex.August 8, 2022 · Drugs · Contamination · Type I
- Jamp-Atorvastatin 40 mg tablets recalled due to risk of latex contaminationAugust 6, 2022 · Drugs · Contamination
- Unauthorized health products seized from Productos Latinos El Aguila in Leamington, OntarioAugust 5, 2022 · Health products · Product safety
- NORMOSOL-R: Solution bags may be leaking in affected lot.August 4, 2022 · Drugs · Product quality · Type I
- Sodium Chloride Inj; Glass particlesAugust 2, 2022 · Drugs · Product quality · Type I
- IMVAMUNE Vaccine: Updated Storage Conditions and Shelf LifeJuly 29, 2022 · Biologic or vaccine · New safety information - Product safety
- Apotex recalls Apo-Acyclovir tablets due to a nitrosamine impurityJuly 28, 2022 · Drugs · Contamination
- Buying health products online? Know the risksJuly 20, 2022 · Drugs · Unauthorized product
- CALCIUM BOROGLUCONATE 23% STERILE INJECTION: Particulate MatterJuly 15, 2022 · Veterinary drugs · Product quality · Type I
- Xtra: Affected lot contain sodium chlorite levels outside of the labelled claim.July 14, 2022 · Veterinary drugs · Product quality · Type III
- Recall of 99.0% Oxygen USP cylindersJuly 13, 2022 · Drugs · Dosage · Type III
- Recall of Roselisa Elite Eyelash Serum (3mL)July 11, 2022 · Drugs · Unauthorized product · Type II
- Dr. Reddy's Laboratories Canada Inc. recalls a lot of Succinyl Choline Injection USPJune 30, 2022 · Drugs · Contamination · Type I
- United Wings Enterprise Inc. recalls COVID-19 Preventive Prescription products sold without market authorization and unauthorized claims.June 30, 2022 · Drugs · Unauthorized product · Type III
- Shortage of infant formulas for babies with food allergies: what you should know and doJune 29, 2022 · Infant products - Health products · Supply - Other
- GOJO Canada Inc. recalls a lot of Purell Hand Sanitizing WipesJune 23, 2022 · Drugs · Product quality · Type III
- JAMP recalls vitamin D3:Out of SpecificationJune 22, 2022 · Drugs · Product quality · Type II
- Produits de Bien-Être Bodispa recalls sexual enhancement products due to the potential presence of undeclared prescription drug ingredients.June 21, 2022 · Drugs · Undeclared substance · Type I
- Rocky Mountain Soap Company recalls Broadspectrum solar protection products due to a potential microbial contamination.June 16, 2022 · Drugs · Contamination · Type II
- Rocky Mountain Soap Company recalls hand sanitizers due to the potential presence of undeclared methanolJune 16, 2022 · Drugs · Undeclared substance · Type II
- Unauthorized health products seized from three herbal medicine stores in Calgary, AlbertaJune 16, 2022 · Drugs · Product safety - Unauthorized product
- Distribution of a New Presentation of SPIKEVAX (elasomeran) COVID-19 Vaccine (0.10 mg/mL in 2.5 mL multidose vial) with English-only Vial and Carton LabelsJune 6, 2022 · Biologic or vaccine · Labelling - Packaging - Product safety - COVID
- Impurity - Pro Doc MONTELUKAST SODIUM 5mgJune 2, 2022 · Drugs · Product quality · Type II
- Red Woody & Go-Rilla - Undeclared prescription drug sildenafil.June 1, 2022 · Drugs · Undeclared substance · Type I
- PMS-Montelukast: impurityMay 19, 2022 · Drugs · Product quality · Type II
- Leucovorin Calcium Injection: Out of SpecificationMay 13, 2022 · Drugs · Product safety · Type I
- Advanced Relief Eye Drops: product safetyMay 9, 2022 · Drugs · Product safety · Type II
- COMIRNATY (COVID-19 Vaccine, mRNA, also referred to as Pfizer-BioNTech COVID-19 Vaccine): New Formulation/Presentation for Use in Individuals 12 Years of Age and OlderMay 9, 2022 · Biologic or vaccine · New safety information
- One lot of Pharmasave Advanced Relief Eye Drops and Compliments Advanced Relief Eye Drops recalled because of a packaging error that may pose health risksMay 7, 2022 · Drugs · Product safety
- AA-FENO-SUPER: Product QualityMay 5, 2022 · Drugs · Product quality · Type III
- Pfizer recalls Accupril blood pressure tablets due to a nitrosamine impurityApril 21, 2022 · Drugs · Contamination
- Accupril Tabs: Nitrosamine impurityApril 20, 2022 · Drugs · Contamination · Type I
- EyEnvy Eyelash & Eyebrow conditioner: unlicensed product with ingredient on prescription drug list.April 19, 2022 · Drugs · Unauthorized product · Type II
- Sotrovimab for Injection - Risk of Treatment Failure due to Circulation of SARS-CoV-2 Omicron BA.2 SubvariantApril 14, 2022 · Biologic or vaccine · New safety information - COVID
- Distribution of EVUSHELD (tixagevimab and cilgavimab for injection) with English-Only Vial and Carton LabelsApril 14, 2022 · Drugs · Labelling - Supply - COVID
- ORBAX: Labelling IssueApril 6, 2022 · Veterinary drugs · Labelling · Type III
- NETSPOT: Out of SpecificationMarch 24, 2022 · Radiopharmaceuticals · Product quality · Type III
- Sodium Acetate Injection, USP - Potential for the Presence of Particulate MatterMarch 15, 2022 · Drugs · Product quality - Product safety
- Maximum Strength Acid Reducer Without prescription: NDMA impurityMarch 11, 2022 · Drugs · Product quality · Type I
- Ranitidine products recalled because of a nitrosamine impurityMarch 11, 2022 · Health products · Product safety
- Anticipated shortage of euthanasia products for animalsMarch 10, 2022 · Veterinary drugs · New safety information - Product safety
- 0.9% Sodium Chloride Injection, USP and Lactated Ringer’s Injection, USP - Potential Leak During Pressure InfusionMarch 9, 2022 · Drugs · Product quality - Product safety
- Phytonadione USP: Unspecified impurities are out of specificationMarch 8, 2022 · Drugs · Product quality · Type II
- Sodium Acetate Injection, USP: Particulate matterMarch 7, 2022 · Drugs · Product quality · Type I
- Heparin Sodium and 0.9% Sodium Chloride Injection: leak in intravenous bagMarch 7, 2022 · Drugs · Product quality · Type I
- Accuretic (quinapril hydrochloride and hydrochlorothiazide): Nitrosamine ImpurityMarch 4, 2022 · Drugs · Contamination · Type I
- Inderal-LA: Nitrosamine ImpurityMarch 2, 2022 · Drugs · Contamination · Type I
- Teva-Ectosone: product qualityMarch 2, 2022 · Drugs · Product quality · Type III
- Pfizer recalls Inderal-LA (propranolol hydrochloride) capsules due to a nitrosamine impurityMarch 1, 2022 · Drugs · Contamination
- 0.9% Sodium Chloride Injection USP: Leaking solution bagFebruary 28, 2022 · Drugs · Product quality · Type I
- Odan Itraconazole: Out of specificationFebruary 23, 2022 · Drugs · Product quality · Type III
- Octagam 10% (Immune globulin intravenous, Human):Quality issueFebruary 23, 2022 · Drugs · Product quality · Type II
- Distribution of NUVAXOVID with English-only Vial and Carton LabelsFebruary 23, 2022 · Drugs · Labelling - Product safety - Supply - COVID
- Auralgan: Impurities out of specificationFebruary 4, 2022 · Drugs · Product quality · Type II
- BEOVU (brolucizumab) – Risk of Intraocular Inflammation, Retinal Vasculitis and/or Retinal Vascular OcclusionFebruary 3, 2022 · Drugs · New safety information - Product safety
- Reddy-Dasatinib: out of specificationJanuary 31, 2022 · Drugs · Product quality · Type III
- ELAVIL 10mg: NDMA impurityJanuary 26, 2022 · Drugs · Product safety · Type I
- APO-AMITRIPTYLINE 10mg: NDMA impurityJanuary 26, 2022 · Drugs · Product safety · Type I
- Piperacillin and Tazobactam for injection: ParticulateJanuary 17, 2022 · Drugs · Product quality · Type I
- PAXLOVID (nirmatrelvir and ritonavir) - Dosing and Dispensing in Renal Impairment, Risk of Serious Adverse Reactions Due to Drug Interactions, and English-Only LabelsJanuary 17, 2022 · Drugs · Labelling - New safety information - Supply - COVID
- XELJANZ/XELJANZ XR (tofacitinib) – Risk of Major Adverse Cardiovascular Events, Malignancy, Thrombosis and InfectionJanuary 12, 2022 · Drugs · New safety information - Product safety
- Health Canada safety review finds link between the use of Xeljanz and Xeljanz XR (tofacitinib) and increased risk of serious heart-related issues and cancerJanuary 12, 2022 · Drugs · Product safety
- Shelf Life Extension for the SPIKEVAX (elasomeran) COVID-19 Vaccine with Printed Expiry Dates on Vial and Carton LabelsJanuary 11, 2022 · Biologic or vaccine · Labelling - Packaging - Product safety - Supply
- Casirivimab and Imdevimab – High Risk of Treatment Failure Due to Circulation of SARS-CoV-2 Omicron VariantJanuary 7, 2022 · Biologic or vaccine · New safety information - COVID
Natural health products
- Flourimax suspension: Out of specificationDecember 15, 2022 · Natural health products · Product quality · Type III
- Now Kids Vitamin D-3: Out of SpecificationDecember 8, 2022 · Natural health products · Product quality · Type I
- Tums Peppermint Regular Strength Tablets: Foreign matterDecember 5, 2022 · Natural health products · Health products · Type II
- TUMS Peppermint Regular Strength tablets: One lot recalled due to contaminationNovember 30, 2022 · Natural health products · Contamination - Product safety
- Pedialyte: The seals of the affected batch may be defective.October 18, 2022 · Natural health products · Product safety · Type II
- Mammoth L-Carnitine 1500-C: Out of specification in the affected lot(s)October 7, 2022 · Natural health products · Product quality · Type III
- Kre-Alkaline: Out of SpecificationOctober 4, 2022 · Natural health products · Product quality · Type II
- Health Canada warns about certain hand sanitizers that may pose health risks (Part 2 – March 31, 2021 to present)September 12, 2022 · Natural health products · Product safety - COVID
- J.R. Watkins Deep Muscle Warming Balm: Product lot did not meet product specification at end of shelf life.September 2, 2022 · Natural health products · Product quality · Type III
- Carnivor: Product not manufactured to product specifications and does not contain the required risk information.August 19, 2022 · Natural health products · Labelling - Product quality · Type III
- Zero Tolerance Plus Sanitizer: Contains undeclared impurity at elevated levels.August 15, 2022 · Natural health products · Product quality - COVID · Type II
- Magnesium Citrate Oral Solution; Microbial contaminationJuly 25, 2022 · Natural health products · Product quality · Type I
- Equate (lemon flavour), Personnelle (lemon flavour) and Life Brand (lemon and cherry flavours) Magnesium citrate oral solution saline laxatives recalled due to potential microbial contaminationJuly 24, 2022 · Natural health products · Product safety
- Recall of Hydrogen peroxide 3% USP products due to the presence of isopropyl alcohol in some lots.July 21, 2022 · Natural health products · Undeclared substance · Type II
- Kolorz ClearShield Varnish: Package insertJuly 14, 2022 · Natural health products · Packaging · Type III
- Unauthorized products may pose serious health risks (March 26, 2021 to June 3, 2022)June 3, 2022 · Drugs - Natural health products · Unauthorized product
- N-Larg Capsules: Label does not meet Health Canada requirementsMay 27, 2022 · Natural health products · Labelling · Type II
- Fibre 4 with Probiotics: Affected lots may contain active ingredients that are above the labelled dosage.May 20, 2022 · Natural health products · Product quality · Type III
- JAMP-SENNA: Out of SpecificationMay 19, 2022 · Natural health products · Product quality · Type II
- Bio-Calcium: affected lot may contain Bio-Calcium D tablets.May 2, 2022 · Natural health products · Product quality · Type III
- Sucro24: microbiological contaminationApril 27, 2022 · Natural health products · Contamination · Type II
- The Newfoundland Distillery Company - Fighting Spirit: Acetaldehyde outside acceptable limitApril 21, 2022 · Natural health products · Product safety - COVID · Type II
- Rapid Protectant Hand Sanitizer Gel: labellingFebruary 23, 2022 · Natural health products · Labelling - COVID · Type II
- Alcohol Antiseptic 80% (v/v) Topical Solution Hand Sanitizer: Acetaldehyde outside acceptable limitFebruary 8, 2022 · Natural health products · Product safety - COVID · Type II
- The Newfoundland Distillery Company - Fighting Spirit: Acetaldehyde outside acceptable limitFebruary 8, 2022 · Natural health products · Product safety - COVID · Type II
- Vitastack: missing risk statementFebruary 4, 2022 · Natural health products · Packaging · Type II
- Health Canada warns that products sold by Kerela Ayurvedic & Natural Herbal Consultation in Toronto, ON, may pose serious health risksFebruary 1, 2022 · Natural health products · Product safety - Unauthorized product
Medical devices
- Nuclear Medicine SystemsDecember 30, 2022 · Radiology · Performance · Type I
- CraniotomeDecember 30, 2022 · General and plastic surgery - Orthopaedics · Performance · Type II
- Orise Gel Pack and Procedure KitDecember 30, 2022 · Ear, nose and throat - General and plastic surgery - General hospital and personal use · Performance · Type II
- Cardinal Health™ Channel Wound DrainsDecember 30, 2022 · General hospital and personal use · Performance · Type II
- Luminos Agile MaxDecember 30, 2022 · Radiology · Performance · Type II
- Epoc Blood Analysis SystemDecember 23, 2022 · Chemistry - General hospital and personal use · Performance · Type II
- Alinity M SystemDecember 23, 2022 · Chemistry · Performance · Type II
- Luminos And Axiom FootrestsDecember 23, 2022 · Radiology · Performance · Type II
- Cobas Infinity Central LabDecember 23, 2022 · General hospital and personal use · Performance · Type II
- Teleflex Stylet, Endotracheal Kit and Flexi-SetDecember 22, 2022 · Anaesthesiology · Performance · Type II
- Nexgen Complete Knee Solution Stemmed Non-Augment Tibial Comp (Cr/Ps) OptionDecember 22, 2022 · Orthopaedics · Performance · Type II
- Mahurkar Acute Dual Lumen Catheter KitsDecember 22, 2022 · Gastroenterology and urology · Performance · Type II
- BC-3600 Auto Hematology Analyzer - BC-3D Hematology ControlDecember 22, 2022 · Haematology · Sterility · Type II
- Airo Mobile Ct SystemDecember 22, 2022 · Radiology · Labelling and packaging · Type II
- Cadd Medication Cassette ReserviorDecember 22, 2022 · General hospital and personal use · Performance · Type II
- Trilogy VentilatorsDecember 21, 2022 · Anaesthesiology · Performance · Type I
- Cadd Administration SetDecember 21, 2022 · General hospital and personal use · Performance · Type II
- Vanta/Sequentia Lt Clinician Programmer ApplicationDecember 21, 2022 · General and plastic surgery · Performance · Type II
- Stradis Implant PacksDecember 21, 2022 · General and plastic surgery · Sterility · Type II
- RegenKit® BCT-3December 21, 2022 · Chemistry · Performance · Type II
- Heartware Ventricular Assist System - HVAD Implant KitDecember 16, 2022 · General hospital and personal use · Performance · Type II
- 3T MRI SystemsDecember 16, 2022 · Radiology · Performance · Type I
- Rsdl Reactive Skin Decontamination LotionDecember 16, 2022 · General hospital and personal use · Performance · Type II
- Guarded Luer ConnectorDecember 16, 2022 · General hospital and personal use · Labelling and packaging · Type II
- Heartstart Defibrillation PadsDecember 15, 2022 · Cardiovascular · Performance · Type II
- Medline PacksDecember 15, 2022 · General hospital and personal use · Performance · Type II
- Leukosure Enumeration KitDecember 15, 2022 · Haematology · Performance · Type II
- Criticool Control UnitDecember 15, 2022 · Cardiovascular · Performance · Type II
- Fetal Spiral ElectrodeDecember 15, 2022 · Obstetrics and gynaecology · Performance · Type II
- Med-Rx Universal Anesthesia KitsDecember 14, 2022 · Anaesthesiology · Labelling and packaging · Type II
- VENTANA PD-L1 (SP142)December 14, 2022 · Medical devices · Performance · Type II
- Battery Mobile X-Ray Systems SoltusDecember 14, 2022 · Radiology · Performance · Type II
- Alinity M Resp-4-Plex Amplification (Amp) Kit (Ce)December 14, 2022 · Medical devices · Performance · Type II
- Ortho ConnectDecember 14, 2022 · Haematology · Performance · Type II
- Medtronic Nonabsorbable SuturesDecember 13, 2022 · General hospital and personal use · Sterility · Type I
- Evolut Pro+ Transcatheter Aortic ValveDecember 13, 2022 · Cardiovascular · Labelling and packaging · Type I
- Oncentra BrachyDecember 13, 2022 · Radiology · Performance · Type II
- Medline Custom Procedure Packs - Sterile BladesDecember 13, 2022 · Cardiovascular - General hospital and personal use · Labelling and packaging · Type II
- Novum Iq Large Volume Pump (LVP)December 9, 2022 · General hospital and personal use · Performance · Type I
- Revaclear 400 Dialyzer; Revaclear 300 DialyzerDecember 2, 2022 · Anaesthesiology · Performance · Type II
- BBL™ Chocolate II AgarDecember 2, 2022 · Chemistry · Performance · Type II
- Vitros ECi Immunodiagnostic Intact PTH ReagentDecember 2, 2022 · Chemistry · Performance · Type II
- Sensis VibeDecember 2, 2022 · Radiology · Device compatibility - Performance · Type II
- BD Alaris Large Volume PumpDecember 1, 2022 · General hospital and personal use · Device compatibility · Type II
- Tracoe Experc Percut Dilation SetsDecember 1, 2022 · Anaesthesiology · Performance · Type II
- Irispec Ca/Cb/CcNovember 25, 2022 · Chemistry · Performance · Type II
- PDS (Polydioxanone) Monofilament SutureNovember 25, 2022 · General and plastic surgery · Performance · Type II
- Aquac Uno H Reverse Osmosis System - Main UnitNovember 25, 2022 · Chemistry · Performance · Type II
- T2100 TreadmillNovember 25, 2022 · Physical medicine · Performance · Type II
- Power-Pro 2November 25, 2022 · Physical medicine · Performance · Type II
- Ortho Optix™ ReaderNovember 25, 2022 · Haematology · Performance · Type II
- Vivid Ultrasound SystemsNovember 24, 2022 · Radiology · Performance · Type II
- Modified Saf TransportNovember 24, 2022 · Medical devices · Performance · Type II
- Autocat 2 SystemsNovember 24, 2022 · Cardiovascular · Performance · Type I
- Magec 2 DeviceNovember 24, 2022 · Orthopaedics · Sterility · Type II
- 3M™ Steri-Drape™ Surgical Drapes PacksNovember 24, 2022 · Health products - Cardiovascular - General hospital and personal use - Orthopaedics · Performance · Type II
- Jamshidi Bone Marrow Biopsy/Aspiration NeedleNovember 24, 2022 · General hospital and personal use · Labelling and packaging - Sterility · Type II
- V. Mueller Bipolar ForcepsNovember 14, 2022 · General and plastic surgery · Labelling and packaging · Type II
- Single Use Oats SetNovember 14, 2022 · Orthopaedics · Device compatibility - Labelling and packaging · Type II
- Easystand BantamNovember 14, 2022 · Physical medicine · Performance · Type II
- Permanent Life Support SetNovember 14, 2022 · Cardiovascular · Sterility · Type II
- Ranger Blood/Fluid Warming SystemsNovember 14, 2022 · General hospital and personal use · Performance · Type II
- Trackmaster TreadmillsNovember 14, 2022 · Medical devices · Performance · Type II
- Safety Cartridge SterileNovember 14, 2022 · General and plastic surgery · Sterility · Type II
- Custom-Pak™ Ophthalmic Surgery Procedure PackNovember 10, 2022 · General hospital and personal use · Performance · Type II
- 2.5mm Lifeport Adapters and Patient Circuit KitsNovember 10, 2022 · Anaesthesiology · Performance · Type II
- Progressa (Frame)November 10, 2022 · Orthopaedics · Performance · Type II
- Pinnacle and Cirrus Ceiling LiftNovember 10, 2022 · General hospital and personal use · Performance · Type II
- Enduracharge 36v Li-Ion BatteryNovember 10, 2022 · Medical devices · Performance · Type II
- Neo-Fit Neonatal Endotracheal Tube GripNovember 10, 2022 · Ear, nose and throat · Performance · Type II
- Liberator Stationary Liquid Oxygen DeviceNovember 9, 2022 · Anaesthesiology · Performance · Type II
- Emblem MRI S-ICD PGNovember 9, 2022 · Cardiovascular · Performance · Type II
- Unlicensed ozone saunas may pose serious health risks to users and anyone in close proximityNovember 2, 2022 · Medical devices · Product safety - Unauthorised device
- Extension Table TopNovember 2, 2022 · General and plastic surgery · Performance · Type II
- Da Vinci Xi/X Sureform 45/60 StaplerNovember 2, 2022 · General and plastic surgery · Performance · Type II
- Omnipod Dash SystemOctober 27, 2022 · General hospital and personal use · Performance · Type II
- Sonicaid Freedom Wireless Fetal Monitoring SystemOctober 26, 2022 · Obstetrics and gynaecology · Performance · Type II
- Vitros Chemistry Products Calibrator Kit 9October 26, 2022 · Chemistry · Performance · Type II
- Orise Proknife Procedure and Gel Syringe KitsOctober 26, 2022 · General and plastic surgery - General hospital and personal use · Performance · Type II
- 3m™ Steri-Drape™ Surgical DrapesOctober 19, 2022 · General and plastic surgery · Performance · Type II
- X-Guide X-Mark Probe ToolOctober 19, 2022 · Dental · Performance · Type II
- Cardinal Health Reusable Hot and Cold Gel PacksOctober 14, 2022 · General hospital and personal use · Labelling and packaging · Type II
- Ortho Vision AnalyzersOctober 14, 2022 · Haematology · Performance · Type II
- Mas Omni CardioOctober 14, 2022 · Chemistry · Labelling and packaging · Type II
- V-Loc PBT Non-Absorbable/180 Absorbable DevicesOctober 14, 2022 · General and plastic surgery · Performance · Type II
- G7 Acetabular Shell 3 Hole Osseoti, CementlessOctober 14, 2022 · Orthopaedics · Labelling and packaging · Type II
- Aquilex Fluid Control SystemOctober 14, 2022 · General hospital and personal use · Performance · Type II
- IH-500October 13, 2022 · Haematology · Performance · Type II
- MNA-240 ENCOctober 13, 2022 · Medical devices · Performance · Type II
- Invisus SLP Ultrasound OptionOctober 13, 2022 · Radiology · Unauthorised device · Type II
- Veritas Advanced Infusion PackOctober 10, 2022 · Ophthalmology · Performance · Type II
- Minimed 630g and 670gOctober 3, 2022 · General hospital and personal use · Performance · Type II
- Large Bone Shoulder BoltOctober 3, 2022 · Orthopaedics · Performance · Type II
- Centricity High Acuity AnesthesiaOctober 3, 2022 · General hospital and personal use · Performance · Type II
- Clearpro Double Swivel Closed Suction CatheterOctober 3, 2022 · Anaesthesiology · Performance · Type II
- Artis Pheno SystemSeptember 28, 2022 · Radiology · Performance · Type II
- BD Vacutainer Tube Sodium Fluoride/Potassium OxalateSeptember 28, 2022 · General hospital and personal use · Performance · Type II
- Magnets in certain Philips Respironics sleep therapy masks may cause serious injury to some individualsSeptember 26, 2022 · Medical devices · New safety information
- Prismaflex SetsSeptember 23, 2022 · Gastroenterology and urology · Labelling and packaging · Type II
- Gelita Tuft-It®September 23, 2022 · General and plastic surgery · Performance · Type II
- Leica Microsystems M530 Optics CarrierSeptember 23, 2022 · Ear, nose and throat · Performance · Type II
- Alinity Hs/Hq SystemSeptember 23, 2022 · Haematology - Pathology · Performance · Type II
- Mitraclip/Triclip G4 Delivery SystemsSeptember 23, 2022 · Cardiovascular · Performance · Type II
- Respironics MasksSeptember 23, 2022 · Anaesthesiology · Labelling and packaging · Type II
- Flexible CystoscopeSeptember 20, 2022 · Gastroenterology and urology · Sterility · Type II
- Smallbore T-Port Extension SetSeptember 20, 2022 · General hospital and personal use · Performance · Type II
- Xpert EV AssaySeptember 20, 2022 · Medical devices · Performance · Type II
- Anti-GM1 Autoantibodies Elisa IVD TestSeptember 20, 2022 · Medical devices · Performance · Type II
- Heat And Moisture Exchanger (HME) And FiltersSeptember 20, 2022 · Anaesthesiology · Performance · Type II
- Artis Q, Icono and Pheno SystemsSeptember 20, 2022 · Radiology · Performance · Type II
- Ent-Single-Use Suction TubeSeptember 14, 2022 · Ear, nose and throat · Labelling and packaging · Type II
- Vitros Immunodiagnostic Products HIV Combo Reagent PackSeptember 14, 2022 · Haematology · Performance · Type II
- Fep Introcan Safety IV Catheter - Straight (No Wings)September 8, 2022 · General hospital and personal use · Sterility · Type II
- K360 Scalpel HandleSeptember 8, 2022 · General and plastic surgery · Performance · Type II
- Power KneeSeptember 8, 2022 · Orthopaedics · Performance · Type II
- Puritan Bennett 560 VentilatorAugust 31, 2022 · Anaesthesiology · Performance · Type I
- Advanced Perfusion System 1-Base UnitAugust 31, 2022 · Cardiovascular · Performance · Type II
- Evolve Modular Radial Head System - Cocr Stem ComponentAugust 31, 2022 · Orthopaedics · Labelling and packaging · Type II
- Omnilab Advanced and BiPAP A40August 31, 2022 · Anaesthesiology · Performance · Type II
- Ecotest Covid-19 Antigen Rapid Test DeviceAugust 24, 2022 · Pathology · Unauthorised device - COVID · Type II
- Teflon Coated Bentson and WireguidesAugust 22, 2022 · Cardiovascular - General hospital and personal use - Radiology · Sterility · Type II
- Powerseal Curved Jaw Sealer & Divider Double ActionAugust 22, 2022 · General and plastic surgery · Performance · Type II
- Ortho Optix™ ReaderAugust 22, 2022 · Haematology · Performance · Type II
- Corvocet Biopsy SystemAugust 22, 2022 · Gastroenterology and urology · Performance · Type II
- Microclave Clear Connectors - Central Catheter PacksAugust 22, 2022 · General hospital and personal use · Performance · Type II
- Vanta Clinician Programmer ApplicationAugust 15, 2022 · General hospital and personal use · Performance · Type II
- Vanta/Sequentia Lt Clinician Programmer ApplicationAugust 15, 2022 · General hospital and personal use · Performance · Type II
- Clarity Retainers, Attachment Template and AlignersAugust 15, 2022 · Dental · Performance · Type II
- Cobas Analytical and Supply UnitAugust 15, 2022 · Chemistry - General hospital and personal use · Performance · Type II
- BD Maxguardtm Extension SetsAugust 8, 2022 · Dental - General hospital and personal use · Labelling and packaging · Type II
- Microclave Clear SetsAugust 8, 2022 · General hospital and personal use · Performance · Type II
- Counterfeit COVID-19 antigen rapid test kits found in OntarioAugust 5, 2022 · Medical devices · Product safety
- HL7 Outbound Results InterfaceAugust 4, 2022 · General hospital and personal use · Software defect · Type II
- Activa Clinician Programmer Application For Deep Brain StimulationAugust 2, 2022 · General hospital and personal use · Device compatibility · Type II
- Nobel Biocare N1 Tiultra Tcc NpAugust 2, 2022 · Dental · Performance · Type II
- Pulmovista 500 SystemAugust 2, 2022 · Radiology · Device compatibility · Type II
- Assurity Mri Pulse GeneratorAugust 2, 2022 · Cardiovascular · Performance · Type I
- Self-Righting Luer Slip And Lock Tip CapsAugust 2, 2022 · General hospital and personal use · Sterility · Type II
- Vitros Xt SystemsAugust 2, 2022 · Chemistry · Performance · Type II
- Giraffe/Panda IRES WarmerAugust 2, 2022 · General hospital and personal use · Labelling and packaging · Type II
- Vitek® 2 Ast-N391August 2, 2022 · Medical devices · Labelling and packaging · Type II
- Onetouch Reveal Mobile App (iOS/Andriod)August 2, 2022 · General hospital and personal use · Software defect · Type II
- Phaseal Y – Site Connector C80August 2, 2022 · General hospital and personal use · Labelling and packaging · Type II
- Centricity Universal Viewer And Universal ViewerAugust 2, 2022 · Radiology · Performance · Type II
- NexSys PCS 300/ PCS2 Plasma Collection SystemAugust 2, 2022 · Gastroenterology and urology - Haematology · Performance · Type II
- Dimension Vista System - Ca15-3 Flex Reagent CartridgeJuly 25, 2022 · Medical devices · Performance · Type II
- Everflex Self-Expanding Peripheral Stent With Entrust Delivery SystemJuly 25, 2022 · Cardiovascular · Performance · Type II
- Roadrunner GuidewireJuly 25, 2022 · Cardiovascular · Performance · Type II
- Pentacam AxlJuly 25, 2022 · Ophthalmology · Performance · Type II
- Hls Set Advanced 5.0 and 7.0 With Bioline CoatingJuly 25, 2022 · Gastroenterology and urology · Labelling and packaging · Type II
- EM2400 Exactamix Valve SetJuly 25, 2022 · General hospital and personal use · Performance · Type II
- Asp6025 and Asp300 SJuly 25, 2022 · Pathology · Performance · Type II
- HLS Set Advanced Bioline CoatingJuly 25, 2022 · Gastroenterology and urology · Labelling and packaging · Type II
- Med-Rx Epidural Anesthesia KitJuly 25, 2022 · Anaesthesiology · Labelling and packaging · Type II
- Emblem S-Icd and Latitude Programming SystemsJuly 25, 2022 · Cardiovascular · Performance · Type II
- Zoom Latitude Programmer/Recorder/Monitor (Prm)July 25, 2022 · Cardiovascular · Performance · Type II
- Kaluza C SoftwareJuly 25, 2022 · Chemistry · Performance · Type II
- Straight Rod - TIJuly 20, 2022 · Orthopaedics · Quality · Type II
- Alphenix INFX-8000v Main UnitJuly 18, 2022 · Radiology · Performance · Type II
- BD Veritor Plus AnalyzerJuly 18, 2022 · Chemistry · Performance · Type II
- CereLink ICP MonitorJuly 18, 2022 · Neurology · Performance · Type II
- Neuromate Stereotactic SystemJuly 18, 2022 · Neurology · Performance · Type I
- Pas Staining KitJuly 18, 2022 · Pathology · Performance · Type II
- Ventana HE 600 SystemJuly 18, 2022 · Pathology · Performance · Type II
- Centricity Radiology, Zero Footprint and Pacs SystemsJuly 15, 2022 · General hospital and personal use - Radiology · Inaccurate test or measurement results · Type II
- Blood Group Reagent Anti-Lea (Murine Monoclonal)BiocloneJuly 11, 2022 · Haematology · Performance · Type II
- Level 1 H-2 Pressure ChamberJuly 11, 2022 · General hospital and personal use · Performance · Type I
- Syngo.ViaJuly 11, 2022 · Radiology · Performance · Type II
- Siemens Healthcare MagnetomJuly 11, 2022 · Radiology · Performance · Type II
- Pro+ MattressJuly 11, 2022 · General hospital and personal use · Performance · Type II
- ICU Medical Inc. Chemolock™July 11, 2022 · General hospital and personal use · Performance · Type II
- Sight Olo-E1 & Sight Olo-U1July 11, 2022 · Haematology · Performance · Type II
- Skytron Channel MountJuly 11, 2022 · General and plastic surgery · Performance · Type II
- Attune Measured Sizing And Rotation GuideJuly 11, 2022 · Orthopaedics · Performance · Type II
- Nuclisens® - Magnetic SilicaJuly 11, 2022 · Medical devices · Performance · Type II
- Hemo-O-Lock & Endowrist Clip ApplierJuly 11, 2022 · General and plastic surgery - General hospital and personal use · Performance · Type I
- Teg 6sJuly 11, 2022 · Haematology · Performance · Type II
- X-Stream Laparoscopic Irrigation ControllerJuly 11, 2022 · Gastroenterology and urology · Performance · Type II
- Anti-Lua (Lu1)July 11, 2022 · Haematology · Inaccurate test or measurement results · Type II
- Heartware Ventricular Assist System – Heartware BatteryJuly 4, 2022 · General hospital and personal use · Performance · Type I
- INOmax DSJuly 4, 2022 · Anaesthesiology · Performance · Type II
- Servo-N and Servo-UJuly 4, 2022 · Anaesthesiology · Performance · Type II
- Centricity Pacs Workstation - SoftwareJuly 4, 2022 · Radiology · Performance · Type II
- Crome and Cobalt MRI SurescanJuly 4, 2022 · Cardiovascular · Performance · Type I
- Vanta With Adaptive Stim TechnologyJuly 4, 2022 · Neurology · Performance · Type II
- Tacticath Contact Force Ablation Catheter, Sensor EnabledJuly 4, 2022 · Cardiovascular · Performance · Type II
- Intraosseous Powered Drive and Needle KitsJune 27, 2022 · General and plastic surgery - General hospital and personal use · Performance · Type II
- Tps System - Elite BursJune 27, 2022 · General and plastic surgery · Performance · Type II
- Aquac Uno H Reverse Osmosis System - Main UnitJune 27, 2022 · Chemistry · Performance · Type II
- Defigard Touch7June 27, 2022 · Cardiovascular · Performance · Type II
- Digital ThermometerJune 27, 2022 · General hospital and personal use · Unauthorised device · Type II
- Fingertip Pulse OximeterJune 27, 2022 · General hospital and personal use · Unauthorised device · Type II
- Infrared ThermometerJune 27, 2022 · General hospital and personal use · Unauthorised device · Type II
- Merlin Patient Care System - Programmer SoftwareJune 27, 2022 · Cardiovascular · Performance · Type II
- NCB Screw 5.0 L=38June 27, 2022 · Orthopaedics · Labelling and packaging · Type II
- Zero Footprint ClientJune 20, 2022 · General hospital and personal use · Performance · Type II
- Modular Cathcart Fracture HeadJune 20, 2022 · Orthopaedics · Labelling and packaging · Type II
- F/O LaryngoscopeJune 20, 2022 · Anaesthesiology - Ear, nose and throat · Labelling and packaging · Type II
- Ambu Vivasight 2 Dlt KitJune 20, 2022 · Anaesthesiology · Performance · Type II
- Epoc Blood Analysis Bgem Test CardsJune 20, 2022 · Chemistry · Performance · Type II
- Coolsculpting System - Applicator - VacuumJune 20, 2022 · Physical medicine · Performance · Type II
- Palindrome/Mahurkar Chronic CatheterJune 20, 2022 · General hospital and personal use · Performance · Type II
- Cholestech Ldx Total, HDL, Triglycerides Cholesterol and Glucose TestJune 20, 2022 · Chemistry · Labelling and packaging - Performance · Type II
- Alinity and Architect A1C Reagent KitJune 20, 2022 · Chemistry · Performance · Type II
- Global PET-CT TablesJune 20, 2022 · Radiology · Performance · Type II
- Trusight Cystic Fibrosis Library Prep KitJune 13, 2022 · Chemistry · Performance · Type II
- Aisys Cs2June 13, 2022 · Anaesthesiology · Performance · Type II
- Minimed Pump battery capJune 13, 2022 · General hospital and personal use · Performance · Type II
- Hydro-Surg Plus Laparoscopic IrrigatorsJune 13, 2022 · General hospital and personal use · Performance · Type II
- Xhibit Telemetry Receiver (Xtr) 96280 V.1.4.0June 13, 2022 · General hospital and personal use · Performance · Type II
- Aisys Cs2June 13, 2022 · Anaesthesiology · Performance · Type II
- Alinity M SystemJune 13, 2022 · Chemistry · Performance · Type II
- Yukon Lock Shaft InserterJune 13, 2022 · Orthopaedics · Performance · Type II
- Evolve Triad Plate CutterJune 13, 2022 · Orthopaedics · Sterility · Type II
- Omniwire Pressure Guide Wire J-TipJune 13, 2022 · Cardiovascular · Sterility · Type II
- Dimension Exl System - Cardiac Troponin-I (CTnI) AssayJune 13, 2022 · Chemistry · Performance · Type II
- Yelloport Elite Universal SealJune 13, 2022 · General and plastic surgery · Sterility · Type II
- Nucleus 7 Processing UnitJune 13, 2022 · Ear, nose and throat · Performance · Type III
- Digital Diagnost C90June 13, 2022 · Radiology · Performance · Type III
- Cardinal Health - Presource KitsJune 13, 2022 · Anaesthesiology - Cardiovascular - General hospital and personal use · Sterility · Type II
- Navicare Nurse CallJune 7, 2022 · Medical devices · Performance · Type II
- Snare, Pediatric, For Slim GastroscopesJune 7, 2022 · Gastroenterology and urology · Performance · Type II
- NordicbrainexJune 7, 2022 · General hospital and personal use · Performance · Type II
- Cortrak 2 Enteral Access SystemJune 7, 2022 · General hospital and personal use · Unauthorised device · Type II
- Soltive Superpulsed Laser Ball Tip Fiber Single UseJune 7, 2022 · General hospital and personal use · Labelling and packaging · Type III
- Infinity Resection GuideJune 7, 2022 · General and plastic surgery · Labelling and packaging · Type II
- Pressure Monitoring SetJune 7, 2022 · Cardiovascular · Performance · Type II
- Palmaz Genesis Biliary Stent/Opta Pro .035" Delivery SystemJune 7, 2022 · Gastroenterology and urology · Performance · Type II
- 1 Series Phototherapy DeviceJune 7, 2022 · General and plastic surgery · Performance · Type II
- Hamilton C6 Intensive Care VentilatorJune 7, 2022 · Anaesthesiology · Performance · Type II
- Inteliq Specialty Immunoassay ControlJune 7, 2022 · Chemistry · Medical devices · Type II
- Duraclone B27 Reagent KitJune 7, 2022 · Medical devices · Performance · Type II
- KN95/FFP2 Particulate Respirator Mask - Model 516WJune 7, 2022 · General hospital and personal use · Unauthorised device · Type II
- Eea Autosuture Circular Stapler With Dst SeriesJune 7, 2022 · General and plastic surgery · Performance · Type II
- Cobalt and Crome Mri SurescanJune 3, 2022 · Cardiovascular - General hospital and personal use · Performance · Type II
- Medline Pill SplitterMay 30, 2022 · General hospital and personal use · Performance · Type II
- Absolute Pro Ll .035 Peripheral Self-Expanding Stent SystemMay 30, 2022 · Cardiovascular · Performance · Type II
- Surestrips Rapid Response Covid-19 Antigen Rapid Test DeviceMay 30, 2022 · General hospital and personal use · Unauthorised device - COVID · Type II
- Heater Unit Hu35May 30, 2022 · Physical medicine · Device compatibility · Type II
- Volista Surgical LightsMay 30, 2022 · Medical devices · Sterility · Type II
- Ortho ConnectMay 30, 2022 · Cardiovascular · Software defect · Type II
- Presource Procedure PacksMay 30, 2022 · General hospital and personal use · Device compatibility · Type II
- Avance and Aespire Anethiesia MachinesMay 30, 2022 · Anaesthesiology · Performance · Type II
- Bond Wash SolutionMay 30, 2022 · Pathology · Device compatibility · Type III
- I-Visc 1%May 30, 2022 · Ophthalmology · Sterility · Type I
- Pagewriter ElectrocardiographMay 30, 2022 · Cardiovascular · Performance · Type III
- Tornado, Nestor and Hilal Embolization MicrocoilsMay 30, 2022 · Cardiovascular - Neurology · Performance - Sterility · Type II
- Alliance Earloop Procedure MaskMay 30, 2022 · General and plastic surgery · Sterility · Type II
- HVAD Implant KitMay 30, 2022 · General hospital and personal use · Performance · Type II
- Surestrips Covid-19 Antigen TestMay 30, 2022 · General hospital and personal use · Unauthorised device - COVID · Type II
- Poches A Sang QuadrupleMay 24, 2022 · Haematology · Performance · Type II
- ABL800 Flex SystemMay 24, 2022 · Chemistry · Performance · Type II
- Ks White Nitrile Medical Examination GlovesMay 20, 2022 · General hospital and personal use · Performance · Type II
- Alinity Hs/Hq SystemMay 16, 2022 · Haematology - Pathology · Performance · Type II
- Carescape Central StationMay 16, 2022 · Cardiovascular · Electrical defect · Type II
- Argyle Safety Fistula Cannula With Anti-Reflux ValveMay 16, 2022 · Cardiovascular · Performance · Type II
- Belotero LidocaineMay 16, 2022 · General and plastic surgery · Quality · Type II
- SOCLEAN 2 AUTOMATED SUPPLEMENTAL PAP MAINTENANCE DEVICEMay 16, 2022 · General hospital and personal use · Performance · Type II
- Hemosil Readiplastin (20 mL Size)May 13, 2022 · Haematology · Performance · Type II
- Health Canada reminds Canadians that plasma pens are unauthorized and may pose health risks, following complaints involving Calgary and North York spasMay 11, 2022 · Medical devices · Unauthorised device
- Plasma pens are not authorized in Canada and may pose health risksMay 11, 2022 · Medical devices · Unauthorised device
- Citadel Bed Frame SystemMay 10, 2022 · General hospital and personal use · Increased risk or new adverse events · Type II
- Breathing System Filter Safestar 55May 10, 2022 · Anaesthesiology · Increased risk or new adverse events · Type I
- Nim™ Standard Reinforced Emg Endotracheal Tube & Nim Contact™ Reinforced Emg Endotracheal TubeMay 10, 2022 · Ear, nose and throat · Revised instructions for use · Type I
- Primus Anaesthetic WorkstationMay 10, 2022 · Anaesthesiology - Cardiovascular · Manufacturing defect · Type II
- BililuxMay 10, 2022 · General hospital and personal use · Manufacturing defect · Type II
- Flexible Video Cysto-Urethroscope (C-View)May 9, 2022 · Gastroenterology and urology · Manufacturing defect · Type II
- Engstrom Pro, Carescape, Engstrom CarestationMay 9, 2022 · Anaesthesiology · Electrical defect · Type II
- Artis Icono BiplaneMay 9, 2022 · Radiology · Software defect · Type II
- ICDs and CRT-DsMay 9, 2022 · Cardiovascular · Software defect · Type II
- Catheter Mount and FiltersMay 9, 2022 · Anaesthesiology · Quality · Type II
- Nimbus Professional Premium MattressMay 9, 2022 · General hospital and personal use · Manufacturing defect · Type II
- Fore-Sight Elite Tissue Oximeter ModuleMay 9, 2022 · Cardiovascular · Inaccurate test or measurement results · Type II
- DuoDerm Sealing defect (2021-08-20)May 4, 2022 · General hospital and personal use · Labelling and packaging · Type II
- Nimbus 4 & Nimbus Professional mattresses (2021-04-13)May 4, 2022 · General hospital and personal use · Manufacturing defect · Type II
- Somatom ForceMay 3, 2022 · Radiology · Software defect · Type II
- Bd Anti-Kappa PeMay 3, 2022 · Haematology · Manufacturing defect · Type II
- Syngo.ViaMay 3, 2022 · Radiology · Software defect · Type II
- Ih-Qc 3May 3, 2022 · Haematology · Increased risk or new adverse events · Type II
- IntelepacsMay 3, 2022 · Radiology · Revised instructions for use · Type II
- Trigen Intertan NailsMay 3, 2022 · Orthopaedics · Manufacturing defect · Type II
- Motorized Wheel SystemMay 3, 2022 · General hospital and personal use · Quality · Type II
- Universal Plus Laparoscopic ElectrodeApril 25, 2022 · General and plastic surgery · Quality · Type II
- Negative Pressure Wound Therapy Sved DeviceApril 25, 2022 · General hospital and personal use · Revised instructions for use · Type II
- Reliance Synergy Washer/DisinfectorApril 25, 2022 · General hospital and personal use · Electrical defect · Type II
- Dragonfly Opstar Imaging CatheterApril 25, 2022 · Cardiovascular · Quality · Type I
- Syngo.ViaApril 25, 2022 · Radiology · Software defect · Type II
- Pico50 Arterial Blood SamplerApril 25, 2022 · Anaesthesiology · Sterility · Type II
- Syngo.ViaApril 25, 2022 · Radiology · Software defect · Type II
- Xvivo Organ ChamberApril 25, 2022 · General hospital and personal use · Revised instructions for use · Type II
- Invacare® Tdx® Sp2 With Narrow Base Battery Wiring HarnessApril 21, 2022 · Physical medicine · Quality · Type II
- Ortho Optix™ ReaderApril 19, 2022 · Haematology · Software defect · Type II
- Cortrak*2 Enteral Access System (Eas)April 19, 2022 · General hospital and personal use · Labelling and packaging · Type I
- Fabian HFOi VentilatorApril 12, 2022 · Anaesthesiology · Software defect · Type I
- Sonialvision G4April 12, 2022 · Radiology · Software defect · Type II
- Zeus Infinity Empowered (Anesthesia Workstation)April 11, 2022 · General hospital and personal use · Performance · Type II
- Karl Storz Se & Co. Kg DevicesApril 11, 2022 · Ear, nose and throat - Gastroenterology and urology · Labelling and packaging · Type II
- Percept Pc Brainsense Deep Brain Stimulation Implantable NeurostimulatorApril 11, 2022 · Neurology · Software defect · Type II
- Disposable Grasping ForcepsApril 11, 2022 · Gastroenterology and urology · Mechanical defect · Type II
- Smart Toe II Intramedullary Arthrodesis ImplantApril 11, 2022 · Orthopaedics · Performance · Type II
- LUMINOS DRF MAX, UROSKOP OMNIA MAX, MULTITOM RAXApril 11, 2022 · Radiology · Software defect · Type II
- Puritan Bennett980 Series VentilatorApril 11, 2022 · Anaesthesiology · Software defect · Type II
- Medfusion Syringe Infusion PumpsApril 11, 2022 · General hospital and personal use · Software defect · Type I
- Vitros® Immunodiagnostic ProductsApril 11, 2022 · Chemistry · Quality · Type II
- Reveal Linq Mobile ManagerApril 11, 2022 · General hospital and personal use · Software defect · Type II
- Updated safety review of breast implants underscores the continuing importance of monitoring for cancer; increased risk with highly textured (macro-textured) implantsApril 6, 2022 · Medical devices · New safety information
- Sara PlusApril 4, 2022 · General hospital and personal use · Increased risk or new adverse events · Type II
- In.Pact Admiral Paclitaxelcoated Pta Balloon CatheterApril 4, 2022 · Cardiovascular · Quality · Type II
- Alinity I Homocysteine Reagent KitApril 4, 2022 · Chemistry · Quality · Type II
- Hugo Ras Arm Cart AssemblyApril 4, 2022 · General and plastic surgery · Manufacturing defect · Type II
- Ellex Tango Reflex and Ultra Q Reflex devicesApril 4, 2022 · Ophthalmology · Revised instructions for use · Type II
- Ultrasonic GastrovideoscopeApril 4, 2022 · Gastroenterology and urology · Unauthorised device · Type II
- Sureform 45/60April 4, 2022 · General and plastic surgery · Performance · Type II
- Vessel SealerApril 4, 2022 · General hospital and personal use · Quality · Type II
- Respironics VentilatorMarch 29, 2022 · Anaesthesiology · Software defect · Type II
- Merlin Patient Care System - Programmer SoftwareMarch 29, 2022 · Cardiovascular · Software defect · Type II
- Prismax Control UnitMarch 29, 2022 · Gastroenterology and urology · Inaccurate test or measurement results · Type II
- Indeflator DeviceMarch 28, 2022 · Cardiovascular · Quality · Type II
- Immulite 2000 System-Human Chorionic Gonadotropin (HCG) AssayMarch 28, 2022 · Chemistry · Inaccurate test or measurement results · Type II
- Mani Diamond Tomita-SawMarch 28, 2022 · Orthopaedics · Unauthorised device · Type II
- Optima MR360March 21, 2022 · Radiology · Increased risk or new adverse events · Type I
- Optima MR450wMarch 21, 2022 · Radiology · Increased risk or new adverse events · Type I
- Optima Mr430s 1.5t - Main UnitMarch 21, 2022 · Radiology · Increased risk or new adverse events · Type I
- Muse™ NXMarch 21, 2022 · General hospital and personal use · Software defect · Type II
- Artis IconoMarch 21, 2022 · General hospital and personal use - Radiology · Software defect · Type II
- Heartstart Defibrillation PadsMarch 21, 2022 · Cardiovascular · Quality · Type II
- Gelita- Spon® Rapid3March 14, 2022 · General and plastic surgery · Increased risk or new adverse events · Type II
- Architect "I" System - Stat Myoglobin AssayMarch 14, 2022 · Chemistry · Unauthorised device · Type II
- Rotawire Drive Guidewire And Wireclip TorquerMarch 14, 2022 · Cardiovascular · Quality · Type II
- Infinity Centralstation WideMarch 14, 2022 · General hospital and personal use · Software defect · Type I
- Med-Rx Medication/Primary Solution Administration KitMarch 14, 2022 · General hospital and personal use · Quality · Type I
- Atellica SystemMarch 14, 2022 · Cardiovascular - Chemistry · Inaccurate test or measurement results · Type II
- Triathlon SystemMarch 14, 2022 · Orthopaedics · Labelling and packaging · Type II
- CompellaMarch 14, 2022 · Physical medicine · Electrical defect · Type II
- Exalt Model D Single-Use DuodenoscopeMarch 14, 2022 · Gastroenterology and urology · Revised instructions for use · Type II
- Ysio X.PreeMarch 14, 2022 · Radiology · Software defect · Type II
- Self-Righting Luer Slip Tip Cap (Discpac, 100 Pack), YellowMarch 14, 2022 · General hospital and personal use · Labelling and packaging · Type II
- Artis SystemMarch 14, 2022 · Radiology · Mechanical defect · Type II
- Catheter Valve IntroducersMarch 14, 2022 · Cardiovascular · Quality · Type II
- Raystation 4-11bMarch 14, 2022 · Radiology · Software defect · Type II
- Restore Wound CleanserMarch 14, 2022 · General and plastic surgery · Unauthorised device · Type II
- Irispec Ca/Cb/CcMarch 14, 2022 · Chemistry · Software defect · Type II
- Dabir SystemMarch 14, 2022 · General hospital and personal use · Revised instructions for use · Type II
- Infinity Acute CareMarch 14, 2022 · Anaesthesiology - Cardiovascular · Software defect · Type II
- Access HstniMarch 14, 2022 · Chemistry · Inaccurate test or measurement results · Type II
- Iq Calibrator Pack and Control/Focus SetMarch 14, 2022 · Chemistry · Quality · Type II
- MENTOR ® Saline Breast ImplantsMarch 10, 2022 · General and plastic surgery · Premature failure · Type II
- Advanta V12March 7, 2022 · Cardiovascular · Quality · Type II
- Liko Universal Twinbar 670 QrhMarch 7, 2022 · General hospital and personal use · Manufacturing defect · Type II
- Acl Top CtsMarch 7, 2022 · Haematology · Inaccurate test or measurement results · Type II
- Spaceoar SystemMarch 7, 2022 · Orthopaedics · Revised instructions for use · Type II
- Cardiohelp-IFebruary 28, 2022 · Gastroenterology and urology · Manufacturing defect · Type II
- Bd AlarisFebruary 28, 2022 · General hospital and personal use · Unauthorised device · Type II
- Clearchoice Foam Face ShieldsFebruary 25, 2022 · General hospital and personal use · Increased risk or new adverse events · Type II
- Temperature ProbesFebruary 21, 2022 · General hospital and personal use · Revised instructions for use · Type III
- Sonialvision G4February 21, 2022 · Radiology · Manufacturing defect · Type II
- Vidas High Sensitive Troponin I (Tnhs)February 21, 2022 · Chemistry · Software defect · Type II
- Baxter Corporation’s MiniCap Extended Life Peritoneal Dialysis Transfer Sets: Certain cleaning products, including hand sanitizers and solvents, may damage setsFebruary 16, 2022 · Medical devices · Medical devices
- Liquiband Fix8 Open Hernia Mesh Fixation DeviceFebruary 14, 2022 · General and plastic surgery · Manufacturing defect · Type I
- Vidas® Cmv Igm (Ref. 30205)February 14, 2022 · Chemistry · Software defect · Type II
- Ysio Radiography X-Ray System - Full MotorizedFebruary 14, 2022 · Radiology · Software defect · Type II
- Heartware Ventricular Assist SystemFebruary 14, 2022 · Cardiovascular - General hospital and personal use · Revised instructions for use · Type II
- Welch Allyn Diagnostic Cardiology ProductsFebruary 14, 2022 · Cardiovascular · Software defect · Type II
- Carescape Central StationFebruary 14, 2022 · Cardiovascular · Manufacturing defect · Type II
- Magec 1February 14, 2022 · Orthopaedics · Revised instructions for use · Type II
- Needle Free Dispensing PinsFebruary 14, 2022 · General hospital and personal use · Increased risk or new adverse events · Type II
- Needle Free Dispensing PinsFebruary 14, 2022 · General hospital and personal use · Increased risk or new adverse events · Type II
- Quantum Blue Anti-InfliximabFebruary 14, 2022 · General hospital and personal use · Inaccurate test or measurement results · Type II
- LiquiBandFIX8® Open Hernia Mesh Fixation DeviceFebruary 11, 2022 · General and plastic surgery · Premature failure · Type III
- 1688 4K PENDULUM CAMERA HEAD WITH INTEGRATED COUPLERFebruary 8, 2022 · Anaesthesiology · Software defect · Type II
- Traverse Rail Carrier And Traverse Rail Carrier E-System, WideFebruary 8, 2022 · General hospital and personal use · Manufacturing defect · Type II
- MinimedFebruary 8, 2022 · General hospital and personal use · Inaccurate test or measurement results · Type II
- Benchmark Ultra Stainer ModuleFebruary 8, 2022 · Pathology · Manufacturing defect · Type II
- Biolox DeltaFebruary 8, 2022 · Orthopaedics · Labelling and packaging · Type II
- Ai Face Recognition Screening MachineFebruary 8, 2022 · General hospital and personal use · Unauthorised device · Type II
- Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console (2021-03-05)February 8, 2022 · Cardiovascular · Manufacturing defect · Type II
- Medical Mask (Adult)January 31, 2022 · General and plastic surgery · Quality · Type II
- Acuson JuniperJanuary 31, 2022 · Radiology · Performance · Type II
- Sight Olo ProductsJanuary 31, 2022 · Haematology · Software defect · Type II
- Acuson Sequoia Diagnostic Ultrasound SystemJanuary 31, 2022 · Radiology · Performance · Type II
- St80i Stress Test SystemJanuary 31, 2022 · Cardiovascular · Software defect · Type II
- Sensis VibeJanuary 31, 2022 · Radiology · Performance · Type II
- Ipela Fhd Ptz Tile Kits (Accessory) For Neuroworks/Sleepworks SoftwareJanuary 31, 2022 · Neurology · Manufacturing defect · Type II
- Interstim Percutaneous ExtensionJanuary 24, 2022 · Gastroenterology and urology · Increased risk or new adverse events · Type II
- Cara V4January 24, 2022 · Ophthalmology · Unauthorised device · Type II
- Liko M220 / M230 Mobile LiftJanuary 24, 2022 · General and plastic surgery · Increased risk or new adverse events · Type I
- Pack,Hot/Cold,Curad,Retail W/CovJanuary 24, 2022 · Physical medicine · Labelling and packaging · Type II
- Navitracker Kit A : KneeJanuary 24, 2022 · Neurology · Increased risk or new adverse events · Type II
- Minicap Extended Life Pd Transfer Set ClampsJanuary 24, 2022 · Gastroenterology and urology · Increased risk or new adverse events · Type II
- Da Vinci Xi And X 12-8 Mm Cannula ReducerJanuary 24, 2022 · General hospital and personal use · Quality · Type II
- Arrow-Trerotola ProductsJanuary 18, 2022 · Cardiovascular · Quality · Type II
- Signa, Discovery and Optima ProductsJanuary 18, 2022 · Radiology · Performance · Type II
- Signa ProductsJanuary 18, 2022 · Radiology · Performance · Type II
- Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 15 Mm, 83 Mm LongJanuary 17, 2022 · Orthopaedics · Increased risk or new adverse events · Type II
- Bd Veritor Plus AnalyzerJanuary 17, 2022 · Medical devices · Increased risk or new adverse events · Type II
- Optima Mr430s 1.5t - Main UnitJanuary 17, 2022 · Radiology · Quality · Type II
- Syngo.ViaJanuary 17, 2022 · Radiology · Quality · Type II
- Somatom Edge ProductsJanuary 17, 2022 · Radiology · Quality · Type II
- Crag Lateral Flow AssayJanuary 17, 2022 · Medical devices · Lack of efficacy · Type II
- Batec Mobility ProductsJanuary 17, 2022 · Physical medicine · Manufacturing defect · Type II
- Endurant Iis Stent Graft SystemJanuary 17, 2022 · Cardiovascular · Manufacturing defect · Type II
- Simplexa Covid-19 Direct AssayJanuary 10, 2022 · Medical devices · Manufacturing defect · Type II
- Duramatrix-Onlay ® Collagen Dura Substitute MembraneJanuary 10, 2022 · General and plastic surgery · Labelling and packaging · Type II
- Nobelreplace Conical Connection Rp 4.3x11.5 MmJanuary 10, 2022 · Dental · Quality · Type II
- Precice SystemJanuary 10, 2022 · Orthopaedics · Revised instructions for use · Type II
- Spectrum Iq Infusion System With Dose Iq Safety SoftwareJanuary 4, 2022 · General hospital and personal use · Performance · Type II
- Sigma Spectrum Infusion Pump With Master Drug Library (V8 Platform)January 4, 2022 · General hospital and personal use · Performance · Type II
- Novum Iq LvpJanuary 4, 2022 · General hospital and personal use · Mechanical defect · Type II
- Nim Trivantage Emg Endotracheal TubeJanuary 4, 2022 · Anaesthesiology · Performance · Type II
- Csan Pronto Test StripsJanuary 4, 2022 · Medical devices · Performance · Type II
- Mic-Peg KitJanuary 4, 2022 · Medical devices · Manufacturing defect · Type II
- Disposable Subdermal Eeg Needle ElectrodeJanuary 4, 2022 · Neurology · Mechanical defect · Type II
- Syngo.ViaJanuary 4, 2022 · Radiology · Software defect · Type II
- Medpor Titan Orbital Floor And Wall (Mtb)January 1, 2022 · General and plastic surgery · Unauthorised device · Type II
- Dall-Miles productsJanuary 1, 2022 · Orthopaedics · Premature failure · Type II
- Mazor X Robotic Guidance SystemJanuary 1, 2022 · Orthopaedics · Inaccurate test or measurement results · Type II
- Vitros Chemistry Products VersatipsJanuary 1, 2022 · Medical devices · Manufacturing defect · Type II
- Delfia XpressJanuary 1, 2022 · Medical devices · Performance · Type II
- Veriseq Pgs KitJanuary 1, 2022 · Medical devices · Unauthorised device · Type II