Medical Device Recalls

This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.

Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.

38,428 total recalls
0 this month

Showing 10441–10460 of 38,428 recalls

May 25, 2022· Mckesson Medical-Surgical Inc. Corporate Office

Recalled Item: a. DYNAREX WeCare PETROLATUM JELLY

The Issue: Facility Temperature excursions (from June 2021-August 2021) prior

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class III — Low RiskOngoing
May 25, 2022· Mckesson Medical-Surgical Inc. Corporate Office

Recalled Item: a. Dynarex DRESSING

The Issue: Facility Temperature excursions (from June 2021-August 2021) prior

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class III — Low RiskOngoing
May 25, 2022· Mckesson Medical-Surgical Inc. Corporate Office

Recalled Item: a. INTEGRA LIFESCIENCE (WND CARE) Shur-Conform Oil Emulsion Oil Emulsion

The Issue: Facility Temperature excursions (from June 2021-August 2021) prior

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class III — Low RiskOngoing
May 25, 2022· Mckesson Medical-Surgical Inc. Corporate Office

Recalled Item: MERIT MEDICAL SYSTEMS StayFIX FIXATION DEVICE

The Issue: Facility Temperature excursions (from June 2021-August 2021) prior

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class III — Low RiskOngoing
May 25, 2022· Mckesson Medical-Surgical Inc. Corporate Office

Recalled Item: a. DERMA SCIENCES

The Issue: Facility Temperature excursions (from June 2021-August 2021) prior

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class III — Low RiskOngoing
May 25, 2022· Mckesson Medical-Surgical Inc. Corporate Office

Recalled Item: a. TIDI PRODUCTS

The Issue: Facility Temperature excursions (from June 2021-August 2021) prior

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class III — Low RiskOngoing
May 25, 2022· Mckesson Medical-Surgical Inc. Corporate Office

Recalled Item: a. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING

The Issue: Facility Temperature excursions (from June 2021-August 2021) prior

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class III — Low RiskOngoing
May 25, 2022· Mckesson Medical-Surgical Inc. Corporate Office

Recalled Item: a. Rapid Test Kit Coag-Sense Professional Blood Coagulation Test Prothrombin

The Issue: Facility Temperature excursions (from June 2021-August 2021) prior

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
May 25, 2022· Mckesson Medical-Surgical Inc. Corporate Office

Recalled Item: FISHER SCIENTIFIC Fisherbrand SWAB

The Issue: Facility Temperature excursions (from June 2021-August 2021) prior

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
May 25, 2022· Mckesson Medical-Surgical Inc. Corporate Office

Recalled Item: a. ABX PENTRA CREATININE 120CP JAFFE 120/130. . b.

The Issue: Facility Temperature excursions (from June 2021-August 2021) prior

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
May 25, 2022· Mckesson Medical-Surgical Inc. Corporate Office

Recalled Item: MedSource IV Start kit

The Issue: Facility Temperature excursions (from June 2021-August 2021) prior

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
May 25, 2022· Mckesson Medical-Surgical Inc. Corporate Office

Recalled Item: Perifix LOR Syringe Perifix 8 mL Pouch Luer Lock Tip

The Issue: Facility Temperature excursions (from June 2021-August 2021) prior

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
May 25, 2022· Mckesson Medical-Surgical Inc. Corporate Office

Recalled Item: Excelsior Heparin Sodium

The Issue: Facility Temperature excursions (from June 2021-August 2021) prior

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
May 25, 2022· Mckesson Medical-Surgical Inc. Corporate Office

Recalled Item: CENTURION MEDICAL PRODUCTS

The Issue: Facility Temperature excursions (from June 2021-August 2021) prior

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
May 25, 2022· Mckesson Medical-Surgical Inc. Corporate Office

Recalled Item: BECKMAN COULTER

The Issue: Facility Temperature excursions (from June 2021-August 2021) prior

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
May 25, 2022· Mckesson Medical-Surgical Inc. Corporate Office

Recalled Item: MAGELLAN DIAGNOSTICS LeadCare II Blood Lead Test Kit Rapid Test

The Issue: Facility Temperature excursions (from June 2021-August 2021) prior

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
May 25, 2022· Mckesson Medical-Surgical Inc. Corporate Office

Recalled Item: a. METREX RESEARCH CORP CaviCide1 DISINFECTANT

The Issue: Facility Temperature excursions (from June 2021-August 2021) prior

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
May 25, 2022· Mckesson Medical-Surgical Inc. Corporate Office

Recalled Item: a. Medefil Normal Saline IV Flush Syringe NORMAL SALINE FLUSH

The Issue: Facility Temperature excursions (from June 2021-August 2021) prior

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
May 25, 2022· Mckesson Medical-Surgical Inc. Corporate Office

Recalled Item: a. MERIT MEDICAL SYSTEMS Aspira Dressing Kit Aspira Model Number:

The Issue: Facility Temperature excursions (from June 2021-August 2021) prior

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
May 25, 2022· Mckesson Medical-Surgical Inc. Corporate Office

Recalled Item: MEDICAL CHEMICAL CORPORATION Total-Fix STOOL COLL KIT

The Issue: Facility Temperature excursions (from June 2021-August 2021) prior

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing