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.
Showing 10461–10480 of 38,428 recalls
Recalled Item: BEAVER-VISITEC INTERNATIONAL
The Issue: Facility Temperature excursions (from June 2021-August 2021) prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STERIS CORP Revital-Ox Resert Hydrogen Peroxide High-Level Disinfectant...
The Issue: Facility Temperature excursions (from June 2021-August 2021) prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HORIBA ABX MEDICAL INC ABX PENTRA ETCHING CP System Fluid
The Issue: Facility Temperature excursions (from June 2021-August 2021) prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BEAVER-VISITEC INTERNATIONAL
The Issue: Facility Temperature excursions (from June 2021-August 2021) prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GETINGE USA SALES LLC OCEAN Chest Drain System Atrium 2100
The Issue: Facility Temperature excursions (from June 2021-August 2021) prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Drugs of Abuse Tests: a. Wondfo Tdip Drugs of Abuse
The Issue: Facility Temperature excursions (from June 2021-August 2021) prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: a. MMS - IMMUNOSTICS INC McKesson Rapid Test Kit Consult
The Issue: Facility Temperature excursions (from June 2021-August 2021) prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: B. BRAUN MEDICAL INC. Anesthesia Support Tray SUPPORT TRAY
The Issue: Facility Temperature excursions (from June 2021-August 2021) prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE INDUSTRIES Medline Plug
The Issue: Facility Temperature excursions (from June 2021-August 2021) prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ethicon SURGIFLO Hemostatic Matrix Kit with Thrombin (6/CS)
The Issue: Facility Temperature excursions (from June 2021-August 2021) prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FISHER SCIENTIFIC Sure-Vue PIPETTE
The Issue: Facility Temperature excursions (from June 2021-August 2021) prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FISHER SCIENTIFIC Aseptic Control¿ LUBRICATING JELLY PAP TEST 4OZ(12/PK) Catalog
The Issue: Facility Temperature excursions (from June 2021-August 2021) prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE INDUSTRIES Centurion IV Securement Kit Model Number: IVSSTK3
The Issue: Facility Temperature excursions (from June 2021-August 2021) prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: a. BECTON DICKINSON BD Vacutainer SST TUBE
The Issue: Facility Temperature excursions (from June 2021-August 2021) prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NANOSONICS LTD Sonex-HL Ultrasound Probe Disinfectant trophon Sonex-HL 80 mL
The Issue: Facility Temperature excursions (from June 2021-August 2021) prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DYNAREX DynaLube LUBRICATING JELLY
The Issue: Facility Temperature excursions (from June 2021-August 2021) prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Wetfield Eraser Bipolar Hemostatic Eraser Wet-Field Eraser 23 Gauge Tapered
The Issue: Facility Temperature excursions (from June 2021-August 2021) prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FISHER SCIENTIFIC Fisherbrand SWAB TRANS STUARTS DBL 50BX Catalog #1490721
The Issue: XXX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
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.
Recalled Item: TELEFLEX LLC Arrow Central Venous Catheter Kit 16
The Issue: Facility Temperature excursions (from June 2021-August 2021) prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.