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 31981–32000 of 38,428 recalls
Recalled Item: Arthroscopy Pack
The Issue: Significant compromised sterility, not limited to potentially damaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Foley Catheter Kit
The Issue: Customed products are being recalled because of compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gown Surgical Fabic Reinforced Large
The Issue: Customed products are being recalled because of compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cypher MIS Screw System-The system includes screws
The Issue: Inoperative screw head seat splay and/or fracture as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Open Heart Pack
The Issue: Significant compromised sterility, not limited to potentially damaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: General Minor Pack
The Issue: Significant compromised sterility, not limited to potentially damaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hip Orthopedia Pack
The Issue: Customed products are being recalled because of compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Recalled by Customed, Inc Due to Significant compromised sterility, not...
The Issue: Significant compromised sterility, not limited to potentially damaged packaging.
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pery Gyn Pack
The Issue: Significant compromised sterility, not limited to potentially damaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Laparotomy Pack
The Issue: Customed products are being recalled because of compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Laparoscopy Pack
The Issue: Significant compromised sterility, not limited to potentially damaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Femoral Pack
The Issue: Significant compromised sterility, not limited to potentially damaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cysto Tur Pack
The Issue: Significant compromised sterility, not limited to potentially damaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Peri Gyn Pack
The Issue: Customed products are being recalled because of compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lithotomy Pack
The Issue: Significant compromised sterility, not limited to potentially damaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Wound Closure Tray I
The Issue: Customed products are being recalled because of compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Angiography Pack
The Issue: Customed products are being recalled because of compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Skin Staple Removal
The Issue: Customed products are being recalled because of compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Peri Gyn Pack
The Issue: Customed products are being recalled because of compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: C-Section Pack
The Issue: Significant compromised sterility, not limited to potentially damaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.