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 14441–14460 of 38,428 recalls
Recalled Item: Perceval Single Use Accessory Kit
The Issue: LivaNova received complaints indicating the impossibility to collapse
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Perceval Single Use Accessory Kit
The Issue: LivaNova received complaints indicating the impossibility to collapse
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AVANOS MIC-KEY SF Gastrostomy Feeding Tube
The Issue: Devices had cracked or detached from the feeding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PROTEXIS Latex Micro Surgical Gloves Size 6.0 - Product Usage:
The Issue: A degradation defect was found that could lead
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PROTEXIS Latex Micro Surgical Gloves Size 8.5 - Product Usage:
The Issue: A degradation defect was found that could lead
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PROTEXIS Latex Micro Surgical Gloves Size 7.5 - Product Usage:
The Issue: A degradation defect was found that could lead
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PROTEXIS Latex Micro Surgical Gloves Size 5.5 - Product Usage:
The Issue: A degradation defect was found that could lead
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PROTEXIS Latex Micro Surgical Gloves Size 8.0 - Product Usage:
The Issue: A degradation defect was found that could lead
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PROTEXIS Latex Micro Surgical Gloves Size 9.0 - Product Usage:
The Issue: A degradation defect was found that could lead
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PROTEXIS Latex Micro Surgical Gloves Size 7.0 - Product Usage:
The Issue: A degradation defect was found that could lead
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PROTEXIS Latex Micro Surgical Gloves Size 6.5 - Product Usage:
The Issue: A degradation defect was found that could lead
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayCare
The Issue: When performing offline image review in RayCare 2C,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Control
The Issue: Product was shipped with refrigeration (ice) instead of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD SafetyGlideTM 3ml 25G x 1 3mL SafetyGlide syringes
The Issue: Printed scale markings on the 3mL SafetyGlide syringes,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Screw Removal Case Assembly
The Issue: Hardware removal kit does not include drivers to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hardware removal kit
The Issue: Hardware removal kit does not include drivers to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: JINYINSHAN
The Issue: Test results revealed that the KN95 masks failed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medcomp 15.SF X 24CM Titan HD CATHETER (CUFF 19CM FROM TIP)
The Issue: Kits were packaged with the incorrect size valve
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Plastic Cannula HOLDEX Item # 450216 - Product Usage: -
The Issue: Sample leaking from the sleeve covering the needle
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 34cc IAB Kit P/N:
The Issue: Endotoxin Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.