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Recalls

A list of FDA Recalls that is updated daily. It references medical equipment and medical product notifications and recalls. 

109 topics in this forum

  1. Hologic, Inc. Recalls BioZorb Marker Due to Complications with Implanted Devices

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    • 161 views

  2. Hospira Inc. Issues A Voluntary Nationwide Recall For Buprenorphine Hydrochloride Injection CarpujectTM Units and Labetalol Hydrochloride Injection, USP CarpujectTM Units Due to the Potential for Incomplete Crimp Seals

    By FDA Recalls,
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    • 162 views

  3. BioZorb Markers and Potential Risks with Use in Breast Tissue: FDA Safety Communication

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    • 153 views

  4. Abbott Recalls HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kit for Risk of Blood Leakage or Air Entering System Between Inflow Cannula and Apical Cuff

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    • 143 views

  5. Philips Respironics, Inc. Recalls Trilogy Evo Continuous Ventilators due to a Software-Related Possible Power Malfunction

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    • 153 views

  6. 2024 Safety Communications

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    • 129 views

  7. Do Not Use Cue Health’s COVID-19 Tests Due to Risk of False Results: FDA Safety Communication

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    • 108 views

  8. Route 92 Medical Inc. Recalls Catheter due to Distal Tip Separation at the Proximal Marker Band

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    • 151 views

  9. MEGADYNE™ Initiates Global Discontinuation and Voluntary Recall of MEGA SOFT™ Pediatric Patient Return Electrode

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    • 184 views

  10. Safety and Quality Concerns with Getinge Cardiovascular Devices - Letter to Health Care Providers

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    • 171 views

  11. Oxygenator Devices Used for Extracorporeal Circulation - Letter to Health Care Providers

    By FDA Recalls,
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    • 103 views

  12. UPDATE: Risk of Device Failures for Getinge’s Maquet/Datascope Cardiosave Intra-Aortic Balloon Pump (IABP) – Letter to Health Care Providers

    By FDA Recalls,
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    • 209 views

  13. Getinge/Maquet Cardiohelp System: Potential Insufficient Packaging Sterility with HLS Set Advanced - Letter to Health Care Providers

    By FDA Recalls,
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    • 140 views

  14. 2024 Letters to Health Care Providers

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    • 126 views

  15. Tandem Diabetes Care, Inc. Recalls Version 2.7 of the Apple iOS t:connect Mobile App Used in Conjunction with t:slim X2 Insulin Pump with Control-IQ Technology Prompted by a Software Problem Leading to Pump Battery Depletion

    By FDA Recalls,
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    • 181 views

  16. BioMérieux Inc. Recalls VITEK 2 AST Kit due to Incorrect Ceftriaxone Concentrations

    By FDA Recalls,
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    • 200 views

  17. SonarMed Inc. Recalls Airway Monitors Due to a Software Anomaly Resulting in Failure to Detect a Partial Obstruction in 2.5mm Sensors and Up To 3mm Distal to the Sensor Tip

    By FDA Recalls,
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    • 111 views

  18. SonarMed Inc. Recalls Airway Acoustic Sensors Due to a Restricted Inner Diameter of Airway Causing Suction Catheter Passage Difficulty

    By FDA Recalls,
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    • 106 views

  19. Elekta Instrument AB Recalls Disposable Biopsy Needle Kit for Leksell Stereotactic System for Possibly Containing Microscopic Stainless Steel Debris on the Inside of the Biopsy Needle

    By FDA Recalls,
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    • 140 views

  20. FDA Encourages the Public to Follow Established Choking Rescue Protocols: FDA Safety Communication

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    • 114 views

  21. Outset Medical, Inc. Recalls Certain Tablo Hemodialysis Systems for Risk of Patient Exposure to Higher Than Allowable Levels of Toxic Compound NDL-PCBAs

    By FDA Recalls,
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    • 139 views

  22. InfuTronix, LLC Recalls Nimbus and Nimbus II Infusion Pump Systems for Multiple Device Failures That May Cause Severe Injury and Death

    By FDA Recalls,
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    • 106 views

  23. Update: Potential Risk of Exposure to Toxic Compounds When Using Hemodialysis and Peritoneal Dialysis Systems – Letter to Health Care Providers

    By FDA Recalls,
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    • 194 views

  24. UPDATE: Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication

    By FDA Recalls,
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    • 143 views

  25. Fresenius Medical Care Recalls Stay-Safe Catheter Extension Sets and Stay-Safe/Luer Lock Adapter for Risk of Patient Exposure to Higher Than Allowable Levels of Toxic Compound NDL-PCBA

    By FDA Recalls,
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    • 185 views
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