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 18121–18140 of 38,428 recalls
Recalled Item: Maquet Getinge- BEQ-TOP 5210 ECC Set - Respiratory Material: 701055604R01
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 30901 CUSTOM CPB PACK Material:701063071
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 40010 OPEN HEART PACK Material: -701067364R02
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 8028 PRESSURE PIGTAIL 4" Material: 701055993
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 41301 BUMC ECC PACK Material: 701065209
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 41303 AV MANIFOLD FOR ECC PA Material:701066551
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 Material:701054874
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 44200 MAYO PULMONARY P Material: 701064831
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 41302 PRIMING LINES BUMC Material:701066291
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 21506 ECC PACK Material:701064505
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 25503 TMC ¿ with BB & QiD Pedi Material:709000473
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 41200 ECC 1/4 PUMP PAC Material: 701063149
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 30901 CUSTOM CPB PACK Material: 701055372
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 8803#Circ Circuit Small Patient Material: 701048539
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: 701068008
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 2302 Pediatric Cardiac Surgery Pack Material: 709000006
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: 701055490R01 BEQ-TOP 15801 ¿ inch ECC
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: 701063255R01 BEQ-TOP 25003 3/8 3/8 up
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 31603 CHKD 3/8" ECC Material: 709000516
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 47800 STRINGFELLOW PED Material:701066583
The Issue: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.