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 12641–12660 of 38,428 recalls
Recalled Item: DONJOY ULTRASLING PRO ER/IR 15
The Issue: failed rivet at the chafe tab of arm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PERLA TL Lateral Connector Open - Product Usage: intended to
The Issue: Due to external labelling error/mix-up. Affected product external
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FISTULA ON-OFF KIT. Medical convenience kit
The Issue: Medical convenience kits are being recalled due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DIALYSIS ACCESS Medical convenience kit
The Issue: Medical convenience kits are being recalled due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COVID-19 Self-Test Kit *** INNOVA *** 3T
The Issue: Due to distributing test kits to customers who
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2
The Issue: Due to distributing test kits to customers who
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADULT CHEST TUBE TRAY. Medical convenience kit
The Issue: Medical convenience kits are being recalled due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FISTULA (ON/OFF) ALL IN ONE BAG. Medical convenience kit
The Issue: Medical convenience kits are being recalled due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COVID-19 Self-Test Kit *** INNOVA *** 7T
The Issue: Due to distributing test kits to customers who
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kit: LVAD Dres Chg. MAI Kit Part Number: 79544B
The Issue: Medical convenience kits are being recalled due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kit: CentralLineDresChangeClrSeq MAI Kit Part Number: 79420
The Issue: Medical convenience kits are being recalled due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kit: Blood Culture. MAI Kit Part Number: 80315D
The Issue: Medical convenience kits are being recalled due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kit: Midline Insertion DA. MAI Kit Part Number: 77981B
The Issue: Medical convenience kits are being recalled due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kit: Injection REVIEW MAI Kit Part Number: 74736
The Issue: Medical convenience kits are being recalled due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kit: Blood Culture MAI Kit Part Number: 80076
The Issue: Medical convenience kits are being recalled due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tripolar Hooked Stimulation Probes
The Issue: The supplier informed them of possible deviations of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SNS Disposable Urethral Catheter Electrode
The Issue: The supplier informed them of possible deviations of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dragonfly Laryngeal Surface Electrode
The Issue: The supplier informed them of possible deviations of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SNS Disposable Urethral Catheter Electrode
The Issue: The supplier informed them of possible deviations of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dragonfly Laryngeal Surface Electrode
The Issue: The supplier informed them of possible deviations of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.