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 18081–18100 of 38,428 recalls
Recalled Item: Maquet Getinge- BEQ-T 5211 ECC Large Children's Hospital Material: 701064560R01
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 50903 Custom ECC Pack-Pedriatric Material: 709000078
The Issue: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fenestrated Tap Adapter (REF# 5001-90011) Product Usage: The K2M Fenestrated
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet Getinge-BEQ-T 46500 PRIME PACK Material:701065823
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 46200 3/16" x 1/4" Neonate Pack Material: 701065620
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 30601 CMC ACCESSORY KIT Material: 701064701
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 57000 Rotaflow Pack Material: 709000424
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 5900 3/8 Quadrox iD Pack w/BB Material: 701050228
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 20705 SMALL PATIENT 1/4 Material: 701053486
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 8068 1/4" WITH BRIDGE Material: 701066883
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 2303 Small Adult Cardiac Surgery Material:709000004
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 49103 ECC Pack 0 No Bladder Material: 709000058
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 4901 Material: 701050839
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 22706 SAMPLE MANIFOLD Material:701054912
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 38300 ADULT CPS QID Material: 701055862
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 8207 1/4" ECC PACK Material: 701068395
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 46201 Small Pediatric Cardiac Surge Material: 709000133
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 36507 Accessory Pk Mercy Material: 709000390
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 46700 ADULT ECC PACK Material:701065833R01
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 28601 NEONATE ECC QPiD Material: 701051935R01
The Issue: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.