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 17961–17980 of 38,428 recalls
Recalled Item: SureSigns VS4 Government Bundle
The Issue: System software inhibits the monitor and as a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SureSigns VS3 NBP
The Issue: System software inhibits the monitor and as a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SureSigns VS3 NBP
The Issue: System software inhibits the monitor and as a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SureSigns VS4 NBP
The Issue: System software inhibits the monitor and as a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet Getinge-BEQ-T 8805 ECC PACK Material: 701053361
The Issue: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet Getinge-BEQ-TOP 33704 ECC 1/4" PACK Material: 701054150
The Issue: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet Getinge-T 8030 4 in High Flow Pigtail Material: 709000366
The Issue: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet Getinge-BEQ-TOP 27901 SMALL PATIENT CI Material:701052287
The Issue: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Skytron Integrity 270 Steam Sterilizer and Skytron Integrity 270VP Steam
The Issue: Weld attaching the air heater assembly to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral
The Issue: Incorrect raw material used by the supplier in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral
The Issue: Incorrect raw material used by the supplier in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral
The Issue: Incorrect raw material used by the supplier in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral
The Issue: Incorrect raw material used by the supplier in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral
The Issue: Incorrect raw material used by the supplier in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral
The Issue: Incorrect raw material used by the supplier in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Neurovascular
The Issue: A design related issue can contribute to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet Getinge-BEQ-TOP 5502 ECC Pack Material:701051791R01
The Issue: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet Getinge-BEQ-TOP 21502# Med City Childr Material: 701050060
The Issue: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet Getinge-BO-TOP 15200 OR PACK HMO & RF Material:701050647R01
The Issue: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet Getinge-BEQ-TOP 22701 Material: 701050790
The Issue: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.