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.

38,428 total recalls
0 this month

Showing 18101–18120 of 38,428 recalls

April 18, 2019· Maquet Cardiovascular, LLC

Recalled Item: Maquet Getinge-BEQ-TOP 33500 3/8" ECC PACK Material: 701053752

The Issue: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization,

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 18, 2019· Maquet Cardiovascular, LLC

Recalled Item: Maquet Getinge- BEQ-TOP 41201 ECC 3/8 Pump Pack Wake For

The Issue: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization,

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 18, 2019· Maquet Cardiovascular, LLC

Recalled Item: Maquet Getinge-BEQ-TOP 31604 CHKD 1/4" ECC Material: 709000518

The Issue: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization,

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 18, 2019· Maquet Cardiovascular, LLC

Recalled Item: Maquet Getinge-BEQ-T-22800 Material: 701049506

The Issue: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization,

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 18, 2019· Maquet Cardiovascular, LLC

Recalled Item: Maquet Getinge- BEQ-T 53500 Evanston Rotaflow Pack Material:709000215R01

The Issue: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization,

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 18, 2019· Maquet Cardiovascular, LLC

Recalled Item: Maquet Getinge- BEQ-TOP 54500 BSW-McLANE 3/8 Quadrox iD Material:709000496R01

The Issue: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization,

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 18, 2019· Maquet Cardiovascular, LLC

Recalled Item: Maquet Getinge-BO-TOP 20700 SMALL PATIENT 3/8 Material: 701050966

The Issue: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization,

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 18, 2019· Maquet Cardiovascular, LLC

Recalled Item: Maquet Getinge-BEQ-TOP 24500 ADULT ECC Material: 701050253

The Issue: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization,

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 18, 2019· Maquet Cardiovascular, LLC

Recalled Item: Maquet Getinge-BEQ-T 4932 Mercy Adaptation Pk Pediatric Material:709000520

The Issue: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization,

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 18, 2019· Maquet Cardiovascular, LLC

Recalled Item: Maquet Getinge-BEQ-TOP 21503 ECC 1/4" AV LOOP Material:701054776

The Issue: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization,

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 18, 2019· Maquet Cardiovascular, LLC

Recalled Item: Maquet Getinge-BEQ-T 39700 ECC PACK Material:701062473

The Issue: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization,

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 18, 2019· K2M, Inc

Recalled Item: Fenestrated Taps 4.5mm

The Issue: Mislabeling

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 18, 2019· Maquet Cardiovascular, LLC

Recalled Item: Maquet Getinge-BEQ-TOP 17207 3/8 ECC PACK Material: 701049346

The Issue: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization,

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 18, 2019· Maquet Cardiovascular, LLC

Recalled Item: Maquet Getinge-BEQ-TOP 24101 Adult ECC Pack Material:701050177R01

The Issue: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization,

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 18, 2019· Maquet Cardiovascular, LLC

Recalled Item: Maquet Getinge-BEQ-TOP 50900 Custom ECC Pack-Neonatal ¿ Material: 709000069R02

The Issue: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization,

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 18, 2019· Maquet Cardiovascular, LLC

Recalled Item: Maquet Getinge BO-TOP 28903 Adult ECC Pack Material: -709000093R01

The Issue: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization,

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 18, 2019· Maquet Cardiovascular, LLC

Recalled Item: Maquet Getinge-BEQ-TOP 24105 ECC PACK Material:701064757

The Issue: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization,

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 18, 2019· Maquet Cardiovascular, LLC

Recalled Item: Maquet Getinge- BEQ-TOP 24100 Small Patient ECC Pack Material:701050175R02

The Issue: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization,

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 18, 2019· Maquet Cardiovascular, LLC

Recalled Item: Maquet Getinge-BEQ-T 52301 ¿ Sash & Accessory Pack Material:-709000266R01

The Issue: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization,

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 18, 2019· Maquet Cardiovascular, LLC

Recalled Item: Maquet Getinge-BEQ-T 30914 ECC Pump Pack 1/4" Material: 709000011

The Issue: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization,

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated