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 16461–16480 of 38,428 recalls

October 22, 2019· Steris Corporation

Recalled Item: Evolution Loading Car and Transfer Carriage- Accessory to the Sterilizer

The Issue: The locking pin of the front wheel asse

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

Class II — Potential Health HazardTerminated
October 22, 2019· Steris Corporation

Recalled Item: Eagle 3000 Sterilizer

The Issue: for the incorrect pressure safety valve being

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

Class II — Potential Health HazardTerminated
October 22, 2019· Edwards Lifesciences, LLC

Recalled Item: EZ Glide Aortic Cannula

The Issue: Their is a possibility that the cannula may

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

Class II — Potential Health HazardTerminated
October 21, 2019· Beckman Coulter Inc.

Recalled Item: MicroScan WalkAway-40 plus Instrument

The Issue: WalkAway Instruments may have been assembled with the

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

Class II — Potential Health HazardOngoing
October 21, 2019· Beckman Coulter Inc.

Recalled Item: DxM 1096 MicroScan WalkAway Instrument

The Issue: WalkAway Instruments may have been assembled with the

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

Class II — Potential Health HazardOngoing
October 21, 2019· Beckman Coulter Inc.

Recalled Item: DxM 1040 MicroScan WalkAway Instrument

The Issue: WalkAway Instruments may have been assembled with the

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

Class II — Potential Health HazardOngoing
October 21, 2019· Beckman Coulter Inc.

Recalled Item: MicroScan WalkAway-40 plus Reconditioned Instrument

The Issue: WalkAway Instruments may have been assembled with the

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

Class II — Potential Health HazardOngoing
October 21, 2019· Beckman Coulter Inc.

Recalled Item: MicroScan WalkAway-96 plus Reconditioned Instrument

The Issue: WalkAway Instruments may have been assembled with the

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

Class II — Potential Health HazardOngoing
October 21, 2019· Beckman Coulter Inc.

Recalled Item: MicroScan WalkAway-96 plus Instrument

The Issue: WalkAway Instruments may have been assembled with the

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

Class II — Potential Health HazardOngoing
October 21, 2019· Haemonetics Corporation

Recalled Item: JAPAN CELL SAVER ELITE SET - 225ML - Product Usage:

The Issue: to develop leaks at the inner core

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

Class II — Potential Health HazardTerminated
October 21, 2019· Haemonetics Corporation

Recalled Item: CS5/5+ Fastpacks

The Issue: to develop leaks at the inner core

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

Class II — Potential Health HazardTerminated
October 21, 2019· Haemonetics Corporation

Recalled Item: JAPAN DISP SET

The Issue: to develop leaks at the inner core

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

Class II — Potential Health HazardTerminated
October 21, 2019· Haemonetics Corporation

Recalled Item: CS Elite Fastpack

The Issue: to develop leaks at the inner core

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

Class II — Potential Health HazardTerminated
October 21, 2019· Haemonetics Corporation

Recalled Item: Japan DISP SET

The Issue: to develop leaks at the inner core

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

Class II — Potential Health HazardTerminated
October 21, 2019· Haemonetics Corporation

Recalled Item: CS5/5+ Fastpacks

The Issue: to develop leaks at the inner core

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

Class II — Potential Health HazardTerminated
October 21, 2019· Haemonetics Corporation

Recalled Item: CS Elite Fastpack

The Issue: to develop leaks at the inner core

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

Class II — Potential Health HazardTerminated
October 21, 2019· Haemonetics Corporation

Recalled Item: Cell Saver¿5/5+ Bowl Kit (225 ml) Autotransfusion Device - Product

The Issue: to develop leaks at the inner core

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

Class II — Potential Health HazardTerminated
October 21, 2019· Haemonetics Corporation

Recalled Item: JAPAN DISP SET

The Issue: to develop leaks at the inner core

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

Class II — Potential Health HazardTerminated
October 21, 2019· Haemonetics Corporation

Recalled Item: Japan CS Elite FASTPACK DISP. SET - 125ML - Product

The Issue: to develop leaks at the inner core

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

Class II — Potential Health HazardTerminated
October 21, 2019· Haemonetics Corporation

Recalled Item: CS Elite Processing Set (225 ml) Autotransfusion Device - Product

The Issue: to develop leaks at the inner core

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

Class II — Potential Health HazardTerminated