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 10421–10440 of 38,428 recalls
Recalled Item: GE Healthcare Avance CS2
The Issue: The base of the anesthesia system can have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HammerTube Implant
The Issue: Due to Titanium plasma coating not present implant
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS¿
The Issue: On-Analyzer Stability (OAS) time, supported for 6 weeks;
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOLTIVE SuperPulsed Laser Fibers
The Issue: Device model and size for affected lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SPS MEDICAL SUPPLY Crosstex International Sterilization Roll Sani-Roll...
The Issue: Facility Temperature excursions (from June 2021-August 2021) prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Absorbent dressings. 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: DERMARITE INDUSTRIES SafeWash Saline Saline Wound Flush SafeWash 7.1 oz.
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. SporView Culture Set SporView Sterilization Biological Indicator Kit Steam
The Issue: Facility Temperature excursions (from June 2021-August 2021) prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DERMARITE INDUSTRIES DermaCol 100 Collagen Powder DermaCol 100 Collagen 1
The Issue: Facility Temperature excursions (from June 2021-August 2021) prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Skin markers: a. IZI MEDICAL PRODUCTS LLC Multi-Modality Markers SKIN
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. DERMARITE INDUSTRIES DermaCol Collagen Dressing DermaCol Without Border...
The Issue: Facility Temperature excursions (from June 2021-August 2021) prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3M SYSTAGENIX/KCI KerraCel Ag DRESSING
The Issue: Facility Temperature excursions (from June 2021-August 2021) prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medical Monofilament Manufacturing MONOFILIMENT TEST
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. Comply INDICATOR
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. STERIS CORP Celerity Celerity 20 Sterilization Indicator Challenge Pack
The Issue: Facility Temperature excursions (from June 2021-August 2021) prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cooper Surgical PREFILTER
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. Skin Adhesive McKesson LiquiBand Exceed 0.4 mL Liquid Dome
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. SPS MEDICAL SUPPLY Steam Indicator Strip SPSmedical Sterilization Chemical
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. 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.
Recalled Item: a. DYNAREX Nice'n Fresh WIPE
The Issue: Facility Temperature excursions (from June 2021-August 2021) prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.