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 18141–18160 of 38,428 recalls
Recalled Item: Maquet Getinge-BEQ-TOP 22702 ECC W/HMOD 30000 Material: 701051179
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 28906 1/4" with Bridge Ancillary P Material: 709000072
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:701050859R01
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 9409 Lurie Chlds Large 3/8 Material: 709000428
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: 701053941R01 BEQ-TOP 9005 3/8 Custom Pk
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 27602 709000417 Adult Custom Pack Material: 709000417
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 8029 PRESSURE PIGTAIL 6" Material: 701055995
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 36504 ADULT ECC PACK Material: 701065765
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 8025 1/4" ECC Pack with RF32 Material:701055142
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 44201 MAYO PULMONARY PACK Material: 701064834
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 32100 Adult Custom Pack Material:701054438R01
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 30300 Material:701052623
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 30907 ECC PUMP PACK Material: 701065770
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: 701053486R01
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 35503 SGD PACK Material: 701067668
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 4903 Mercy Med w/o Oxy Material:701066664
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 52301 ¿ Sash & Accessory Pack Material: 709000266
The Issue: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo Advanced Perfusion System 1 Electronic Patient Gas System
The Issue: The gas flow rate output of the EPGS
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generator PG
The Issue: Updated Warning Statements in the Operator's Manual/Directions for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero...
The Issue: Updated Warning Statements in the Operator's Manual/Directions for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.