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 16301–16320 of 38,428 recalls
Recalled Item: ABL90 FLEX PLUS
The Issue: The analyzers fail on S7950 (Range +) QC
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic MiniMed 630G System with SmartGuard
The Issue: There have been reported incidents of a loose
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic MiniMed 640G Insulin Infusion Pump
The Issue: There have been reported incidents of a loose
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic MiniMed 620G Insulin Infusion Pump
The Issue: There have been reported incidents of a loose
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic MiniMed 670G System with SmartGuard
The Issue: There have been reported incidents of a loose
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The
The Issue: Four units of European version FreeStyle Comfort were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Pin To Rod Coupling External Fixation System Hoffmann II
The Issue: Pin To Rod Coupling could not clamp the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The products involved are DeWALT laser distance measurers
The Issue: The products are labeled as Class II lasers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3M Durapore Advanced
The Issue: While the product meets all safety and efficacy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal KNEE BRACE
The Issue: The Warrior Recovery Knee Brace has the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ProxiDiagnost N90
The Issue: Unexpected increase in peak tube potential (kV) will
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Y-Type Blood Set
The Issue: for leakage at the joint between the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Y-Type Blood Set
The Issue: for leakage at the joint between the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Y-Type Blood Set
The Issue: for leakage at the joint between the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Y-Type Blood Set
The Issue: for leakage at the joint between the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reinforced Introducer Sets Maquet 8 Fr.
The Issue: for compromised sterility in breached pouches of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Safeline Y-Type Blood Set
The Issue: for leakage at the joint between the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Safeline Y-Type Blood Set
The Issue: for leakage at the joint between the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Outlook Safety Infusion System Y-type Blood Set
The Issue: for leakage at the joint between the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reinforced Introducer Sets Maquet 7 Fr.
The Issue: for compromised sterility in breached pouches of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.