Recalls

210 topics in this forum

1. Central Admixture Pharmacy Services (CAPS) Issues Nationwide Recall of Phenylephrine 40 mg Added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bags Due to Visible Black Particulate Matter in a Single-Sealed Vial

   By FDA Recalls, February 25
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   • 76 views
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   • FDA Recalls
   • February 25

3. Ascent Consumer Products Inc. Issues Voluntary Nationwide Recall of SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System Due to Microbial Contamination

   By FDA Recalls, February 25
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   • 67 views
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   • FDA Recalls
   • February 25

4. Pacemaker Recall: Boston Scientific Corporation Recalls Accolade Pacemaker Devices Due to a Manufacturing Issue That May Lead to Early Device Replacement

   By FDA Recalls, February 21
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   • 142 views
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   • FDA Recalls
   • February 21

5. One Source Nutrition, Inc. Issues Voluntary Nationwide Recall of Vitality Capsules Due to Presence of Undeclared Sildenafil and Tadalafil

   By FDA Recalls, February 20
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   • 67 views
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   • FDA Recalls
   • February 20

6. BD Announces Voluntary Worldwide Recall for One Lot of ChloraPrep™ Clear 1 mL Applicators Due to Fungal Contamination

   By FDA Recalls, February 18
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   • 81 views
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   • FDA Recalls
   • February 18

7. Heart Pump Recall: Abiomed, Inc. Updates Use Instructions for Impella RP with SmartAssist and Impella RP Flex with SmartAssist Due to A Risk That the Tip of Guidewires or Other Medical Devices May Come into Contact with The Impella Pump During Insertion,

   By FDA Recalls, February 14
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   • 108 views
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   • FDA Recalls
   • February 14

8. ICU Medical Issues Nationwide Recall of Potassium Chloride Injection, 20 mEq and Potassium Chloride Injection, 10 mEq Due to Mislabeling

   By FDA Recalls, February 14
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   • 94 views
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   • FDA Recalls
   • February 14

9. Breathing Circuit Kit Recall: Sentec/Percussionaire Removes VDR4 Phasitron Breathing Circuits due to Venturi Component Malfunctions that May Reduce Pressure and Volume Flow

   By FDA Recalls, February 10
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   • 72 views
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   • FDA Recalls
   • February 10

10. Early Alert: Atherectomy Catheter System Issue from Bard Peripheral Vascular

    By FDA Recalls, February 6
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    • 106 views
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    • FDA Recalls
    • February 6

11. Arterial Catheter Recall: Medline Industries, LP, Removes Integrated Arterial Catheters due to Excess Material at Catheter Hub that May Detach

    By FDA Recalls, February 6
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    • 101 views
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    • FDA Recalls
    • February 6

12. Continuous Ventilator Correction: Baxter Healthcare Corporation Issues Correction for Life2000 Ventilator due to a nonconforming battery charger, which triggers a battery alarm and renders the ventilator inoperable

    By FDA Recalls, February 5
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    • 94 views
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    • FDA Recalls
    • February 5

13. FDA Alerts Patients to Regularly Check Diabetes-Related Smartphone Device Alert Settings, Especially Following Phone Hardware or Software Changes

    By FDA Recalls, February 5
    • 0 replies
    • 87 views
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    • FDA Recalls
    • February 5

14. Oxygen Concentrator Recall: JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD Removes JMC5A Ni/TruAire-5 Oxygen Concentrator due to the devices spontaneously catching fire

    By FDA Recalls, February 5
    • 0 replies
    • 91 views
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    • FDA Recalls
    • February 5

15. Pressure Monitoring Device Recall: Medtronic Neurosurgery Issues Correction for Becker and Exacta External Drainage and Monitoring Systems Due to Cracks And/Or Leaks in Stopcocks

    By FDA Recalls, February 3
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    • 101 views
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    • FDA Recalls
    • February 3

16. Alvogen Issues Voluntary Nationwide Recall for One Lot of Fentanyl Transdermal System 25 mcg/h Due to a Defective Delivery System

    By FDA Recalls, January 31
    • 0 replies
    • 121 views
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    • FDA Recalls
    • January 31

17. Update on Alert: Endoscope Accessories Forceps/Irrigation Plug Issue from Olympus

    By FDA Recalls, January 31
    • 0 replies
    • 102 views
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    • FDA Recalls
    • January 31

18. Update on Alert: Infusion Pump Issue from Fresenius Kabi USA

    By FDA Recalls, January 31
    • 0 replies
    • 124 views
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    • FDA Recalls
    • January 31

19. Gas Powered Emergency Resuscitator Recall: Mercury Medical Removes Neo-Tee T-Piece Resuscitator Due to An Undersized Spring in The Controller That May Prevent the Device from Delivering the Required Pressure Levels Needed for Effective Ventilation

    By FDA Recalls, January 31
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    • 94 views
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    • FDA Recalls
    • January 31

20. Update on Alert: Nephroscope Sheath Issue from Trokamed GmbH

    By FDA Recalls, January 31
    • 0 replies
    • 107 views
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    • FDA Recalls
    • January 31

21. Update on Alert: Fluid Delivery Set Issue from Medline

    By FDA Recalls, January 31
    • 0 replies
    • 98 views
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    • FDA Recalls
    • January 31

22. Update on Alert: Extracorporeal Blood Circuit Issue from Nuwellis

    By FDA Recalls, January 31
    • 0 replies
    • 92 views
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    • FDA Recalls
    • January 31

23. Cybersecurity Vulnerabilities with Certain Patient Monitors from Contec and Epsimed: FDA Safety Communication

    By FDA Recalls, January 30
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    • 98 views
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    • FDA Recalls
    • January 30

24. Olympus Issues Medical Device Advisory Notice to Use Alternative Devices to the MAJ-891 Forceps/Irrigation Plug

    By FDA Recalls, January 30
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    • 95 views
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    • FDA Recalls
    • January 30

25. Glucose and Glucose/Ketone Meter Correction: Nova Biomedical Corporation Issues Software Correction for StatStrip Glucose and Glucose/Ketone Hospital Meters Due to Risk for Transmission of Incorrect Patient Results

    By FDA Recalls, January 30
    • 0 replies
    • 75 views
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    • FDA Recalls
    • January 30

26. Provepharm Inc. Issues Voluntary Nationwide Recall of One Lot of Phenylephrine Hydrochloride Injection, USP, 10 mg/ mL (Pharmacy Bulk Package) Due to Presence of Particulate Matter

    By FDA Recalls, January 24
    • 0 replies
    • 84 views
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    • FDA Recalls
    • January 24