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 18021–18040 of 38,428 recalls
Recalled Item: Maquet Getinge-BEQ-TOP 250011/4 1/4 Less than 20 kg up Material:
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-T 51502 Ochsner ECC Ancillary Pack Material:709000115
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 8075 S-Quadrox iD Plus Pack wRF3 Material: 709000460
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-T 49002 ROTAFLOW SUPPORT PACK Material: 701067280
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 35503 SGD Pack Material: 701068797
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 8013 ECC QUADROX iD Pack RF32 Material:701047962R01
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 8208#3/8 inch ECC Pack Material: 701068798
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 27609 ECC PACK 1/4" Material: 701065504
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-T 52360 Cardioplegia Pack Material: 709000127
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 26300 CUSTOM PACK Material: 701050975
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 22600 ECC QUADROX iD 3/8 Material:701049440R02
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- (1) Material :701067370R01 BO-TOP 38803 OPEN HEART PACK
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-T 3501 LVAD 3/8" Material: 701068008R01
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 31203 CUSTOM PACK NEO Material: 701065510
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-T 9410 Lurie Chldns Small 1/4 Material: 709000430
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 38302 INFANT CPS QPID Material: 701055866
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-T 4963 CARDIOPLEGIA PACK Material: 701067203
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-T 9403 Small Patient Tubing Pack Material: 701049994
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 15704 Circulatory Circuit 3/8" Material: 701050859
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 25500 ECC 3/8 in AV Loop w Qx-iD
The Issue: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.