Recalls

68 topics in this forum

1. 2024 Medical Device Recalls

   By FDA Recalls, April 30
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   • 125 views
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   • FDA Recalls
   • April 30

2. Vascular Embolization Device Correction: Boston Scientific Updates Use Instructions for Obsidio Conformable Embolic for Increased Ischemia Risk When Used for GI Bleeding

   By FDA Recalls, October 18
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   • FDA Recalls
   • October 18

3. Insulin Pump Recall: Medtronic Notifies Users of MiniMed 600 and 700 Series Pumps of Risk of Shorter than Expected Battery Life

   By FDA Recalls, October 17
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   • FDA Recalls
   • October 17

4. Staska Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Ascorbic Acid Solution for Injection (Preservative Free, Non-Corn) 500mg/mL Due to the Presence of Glass Particles

   By FDA Recalls, October 16
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   • 6 views
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   • FDA Recalls
   • October 16

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

   By FDA Recalls, October 16
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   • 4 views
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   • FDA Recalls
   • October 16

6. C&A Naturistics Issues Voluntary Nationwide Recall of AK Forte Tablets con Ortiga y Omega 3 Due to the Presence of Undeclared Drug Ingredients: Diclofenac, Dexamethasone, and Methocarbamol

   By FDA Recalls, October 16
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   • FDA Recalls
   • October 16

7. Infusion Pump Recall: Zyno Medical Removes Z-800, Z-800F, Z-800W, and Z800WF Infusion Pumps due to an Air-in-Line Software Defect That May Allow Larger than Expected Air Bubbles to Enter Patients

   By FDA Recalls, October 15
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   • 5 views
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   • FDA Recalls
   • October 15

8. Resuscitator Recall: Mercury Medical Removes Neo-Tee T-Piece Resuscitators due to Risk of Inline Controller Detachment that May Impact Ventilation

   By FDA Recalls, October 7
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   • 14 views
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   • FDA Recalls
   • October 7

9. Philips Respironics Issues Additional Usage Instructions for Trilogy Evo Ventilators Related to Use of In-Line Nebulizers

   By FDA Recalls, October 7
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   • 10 views
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   • FDA Recalls
   • October 7

10. IPV Therapy Device Correction: Sentec/Percussionaire Updates Use Instructions for Phasitron 5 In-Line Valve to Prevent Accidental Misuse of Expiratory Port Plug

    By FDA Recalls, October 2
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    • 13 views
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    • FDA Recalls
    • October 2

11. Infusion Pump Software Correction: Fresenius Kabi USA, LLC, Issues Correction for Ivenix Infusion System Large Volume Pump (LVP) Software due to Multiple Anomalies that May Cause Delay or Underdosage of Therapy

    By FDA Recalls, October 1
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    • 10 views
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    • FDA Recalls
    • October 1

12. Ventilator Software Correction: Philips Respironics Issues Mandatory Software Correction and Updates Use Instructions for Trilogy Evo, EV300, EvoO2, and Evo Universal to Address Multiple Issues that May Impact Ventilation

    By FDA Recalls, October 1
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    • 12 views
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    • FDA Recalls
    • October 1

13. Ventilator Correction: Smiths Medical Issues Correction for paraPAC Plus P300 and P310 Ventilators due to Inadvertent Tidal Volume Knob Movement

    By FDA Recalls, September 30
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    • 17 views
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    • FDA Recalls
    • September 30

14. Compounding Device Inlet Correction: Baxter Healthcare Corporation Updates Use Instructions for Exactamix Automated Compounding Device Inlets due to Risk for Particulate Matter in Device Components

    By FDA Recalls, September 24
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    • 39 views
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    • FDA Recalls
    • September 24

15. Electrode Pad Correction: Megadyne Issues Correction for MEGA SOFT, MEGA SOFT DUAL and MEGA 2000 Patient Return Electrodes to Limit Risk of Pediatric Burns

    By FDA Recalls, September 23
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    • 31 views
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    • FDA Recalls
    • September 23

16. Gilead Issues Voluntary Nationwide Recall of One Lot of Veklury (Remdesivir) for Injection 100 mg/vial Due to the Presence of a Glass Particle

    By FDA Recalls, September 23
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    • 29 views
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    • FDA Recalls
    • September 23

17. Megadyne Medical Products, Inc. Recalls Mega Soft Universal Patient Return Electrode Due to Reports of Patient Burns

    By FDA Recalls, September 23
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    • 19 views
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    • FDA Recalls
    • September 23

18. Ventilator Recall: Smiths Medical Removes ParaPAC Plus Ventilators due to Loosened or Detached Patient Outlet Connector

    By FDA Recalls, September 20
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    • 19 views
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    • FDA Recalls
    • September 20

19. Related Recalls - Plastic Syringes Made in China for Potential Device Failures

    By FDA Recalls, September 19
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    • 20 views
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    • FDA Recalls
    • September 19

20. Bionpharma Inc. Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension Due to Bacterial Contamination

    By FDA Recalls, September 18
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    • 28 views
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    • FDA Recalls
    • September 18

21. Tracheostomy Tube Recall: Smiths Medical Removes Certain Bivona Neonatal/Pediatric and Adult Tracheostomy Tubes due to Manufacturing Defect that May Cause Tracheostomy Displacement or Decannulation

    By FDA Recalls, September 18
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    • 14 views
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    • FDA Recalls
    • September 18

22. Infusion Pump Correction: B. Braun Medical Inc. Issues Correction for lnfusomat Space Infusion System/Large Volume Pump, in addition to Infusomat Space Large Volume Pump Wireless, and lnfusomat Space Large Volume Pump Non-Wireless BATTERY PACK, Due to Fau

    By FDA Recalls, September 17
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    • 16 views
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    • FDA Recalls
    • September 17

23. Zimmer Biomet CPT Hip System Femoral Stem and Increased Risk of Thigh Bone Fracture - FDA Safety Communication

    By FDA Recalls, September 17
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    • 29 views
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    • FDA Recalls
    • September 17

24. Infusion Pump Administration Set Recall: Fresenius Kabi USA Removes Certain Ivenix Large Volume Pump Primary Administration Sets

    By FDA Recalls, September 16
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    • 18 views
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    • FDA Recalls
    • September 16

25. FDA Adds Warning About Rare Occurrence of Serious Liver Injury with Use of Veozah (fezolinetant) for Hot Flashes Due to Menopause. Stop Medicine if Signs and Symptoms of Liver Injury Occur - Drug Safety Communication

    By FDA Recalls, September 12
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    • 24 views
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    • FDA Recalls
    • September 12