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 37721–37740 of 38,428 recalls

May 11, 2012· Spacelabs Healthcare, Llc

Recalled Item: The product is Pathfinder SL

The Issue: The firm received reports of the Pathfinder LS

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

Class II — Potential Health HazardTerminated
May 11, 2012· Vygon Corporation

Recalled Item: Vygon VY(TM)Flush Heparin Lock Flush Syringes

The Issue: Manufacturer issued a voluntary recall on multiple lots

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

Class II — Potential Health HazardTerminated
May 11, 2012· Vygon Corporation

Recalled Item: Churchill Medical Systems

The Issue: Manufacturer issued a voluntary recall on multiple lots

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

Class II — Potential Health HazardTerminated
May 11, 2012· Vygon Corporation

Recalled Item: Churchill Medical Systems

The Issue: Manufacturer issued a voluntary recall on multiple lots

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

Class II — Potential Health HazardTerminated
May 11, 2012· Vygon Corporation

Recalled Item: Vygon VY(TM)Flush Heparin Lock Flush Syringes

The Issue: Manufacturer issued a voluntary recall on multiple lots

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

Class II — Potential Health HazardTerminated
May 11, 2012· Vygon Corporation

Recalled Item: Churchill Medical Systems

The Issue: Manufacturer issued a voluntary recall on multiple lots

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

Class II — Potential Health HazardTerminated
May 11, 2012· Vygon Corporation

Recalled Item: Vygon VY(TM)Flush Heparin Lock Flush Syringes

The Issue: Manufacturer issued a voluntary recall on multiple lots

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

Class II — Potential Health HazardTerminated
May 11, 2012· Vygon Corporation

Recalled Item: Churchill Medical Systems

The Issue: Manufacturer issued a voluntary recall on multiple lots

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

Class II — Potential Health HazardTerminated
May 11, 2012· Vygon Corporation

Recalled Item: Churchill Medical Systems

The Issue: Manufacturer issued a voluntary recall on multiple lots

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

Class II — Potential Health HazardTerminated
May 11, 2012· Vygon Corporation

Recalled Item: Vygon VY(TM)Flush Heparin Lock Flush Syringes

The Issue: Manufacturer issued a voluntary recall on multiple lots

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

Class II — Potential Health HazardTerminated
May 11, 2012· Vygon Corporation

Recalled Item: Churchill Medical Systems

The Issue: Manufacturer issued a voluntary recall on multiple lots

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

Class II — Potential Health HazardTerminated
May 11, 2012· Vygon Corporation

Recalled Item: Vygon VY(TM)Flush Heparin Lock Flush Syringes

The Issue: Manufacturer issued a voluntary recall on multiple lots

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

Class II — Potential Health HazardTerminated
May 10, 2012· Perouse Medical

Recalled Item: Perouse Flamingo

The Issue: Perouse Medical in France initiated a voluntary recall

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

Class II — Potential Health HazardTerminated
May 9, 2012· SpineFrontier, Inc.

Recalled Item: Invue Solid Driver

The Issue: The nipple of the tipped driver broke off

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

Class II — Potential Health HazardTerminated
May 9, 2012· Natus Medical Incorporated

Recalled Item: The product has the Catalogue/Part number 60010. Olympic Cool-Cap System

The Issue: The Olympic Cool-Cap's Control Module has experienced a

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

Class I — Serious Health HazardTerminated
May 9, 2012· Aesculap, Inc.

Recalled Item: Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R)

The Issue: The manufacturer informed the recalling firm of a

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

Class II — Potential Health HazardTerminated
May 9, 2012· RAYSEARCH LABORATORIES AB

Recalled Item: RayStation. Generic name: Treatment Planning System. Software version

The Issue: The firm decided to recall when an issue

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

Class II — Potential Health HazardTerminated
May 9, 2012· Terumo Cardiovascular Systems Corporation

Recalled Item: Sarns Antegrade Cardioplegia Cannula: ROOT INFUSTION VENT CATHETER WITH 12

The Issue: During production of the Sarns Antegrade Cardioplegia Cannula,

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

Class II — Potential Health HazardTerminated
May 9, 2012· Terumo Cardiovascular Systems Corporation

Recalled Item: X-COATED TRANSPLANT PACK Product Usage: The Sarns Cardioplegia Cannula and

The Issue: During production of the Sarns Antegrade Cardioplegia Cannula,

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

Class II — Potential Health HazardTerminated
May 9, 2012· Terumo Cardiovascular Systems Corporation

Recalled Item: FX PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent

The Issue: During production of the Sarns Antegrade Cardioplegia Cannula,

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

Class II — Potential Health HazardTerminated