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 17981–18000 of 38,428 recalls
Recalled Item: Maquet Getinge-BEQ-TOP 41201 ECC 3/8 PUMP PAC Material: 701064867
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 13901 Rapid Response Universal Pk Material: 701054874R01
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 3502 LVAD 1/4" Material: 701068168
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 37305 1/4+3/8 TABLE LINE Material: 701067577
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: 701065765R01 BO-TOP 36504 Adult ECC 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-TOP 24202 ADULT ECC Material:701054295
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 32200 ECC Pack Material: 701053319R01
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 5208 ECC SET CARDIAC Material: 701067350
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:701068797R01
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 48400 OR PACK Material: 701064327R01
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 28901 MCV INFANT ECC Material:701056771R01
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 48003 Rotaflow ONLY Support Pack Material:709000490
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 25501 3/8" Better Bladder Pack Material: 709000370
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 44701 PEDIATRIC ECC Material: 701064825
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 5909 1/4 PACK W QPID Material: 701064992
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 8506 Transport Pack Material: 709000146
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 33501 1/4" ECC PACK Material: 701053754
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 38900 ECC PACK Material: 701056368
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: 701047962
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 37200 E-Circuit Bioline Heparin Material: 701055388R01
The Issue: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.