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 32541–32560 of 38,428 recalls

July 25, 2014· Galt Medical Corporation

Recalled Item: GALT VALVED TEARAWAY INTRODUCER SET GALT VTI RX ONLY UNITS

The Issue: The adhesive used in the product could dislodge

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

Class II — Potential Health HazardTerminated
July 25, 2014· Galt Medical Corporation

Recalled Item: GALT VALVED TEARAWAY KIT GALT VTI w/ Sideport Stainless Steel

The Issue: The adhesive used in the product could dislodge

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

Class II — Potential Health HazardTerminated
July 25, 2014· GE Healthcare, LLC

Recalled Item: GE Healthcare

The Issue: GE Healthcare has become aware of a potential

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

Class II — Potential Health HazardTerminated
July 24, 2014· Stryker Howmedica Osteonics Corp.

Recalled Item: Stryker T2 Tibia System Nail Insertion Sleeve

The Issue: Stryker Orthopaedics received a report indicating some of

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

Class II — Potential Health HazardTerminated
July 24, 2014· Philips Healthcare Informatics, Inc.

Recalled Item: Philips IntelliSpace PACS 4.4 image management systems performs digital image

The Issue: A problem was detected in the Philips IntelliSpace

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

Class II — Potential Health HazardTerminated
July 23, 2014· Becton Dickinson & Co.

Recalled Item: The BD MAX MRSA Assay

The Issue: The performance of the assay no longer conforms

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

Class II — Potential Health HazardTerminated
July 23, 2014· Zimmer, Inc.

Recalled Item: Vl DBL OFFST WI LRG STPL

The Issue: The firm received complaints for failure of the

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

Class II — Potential Health HazardTerminated
July 23, 2014· Zimmer, Inc.

Recalled Item: Double Offset Rasp Handle

The Issue: The firm received complaints for failure of the

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

Class II — Potential Health HazardTerminated
July 23, 2014· Zimmer, Inc.

Recalled Item: Double Offset Rasp Handle

The Issue: The firm received complaints for failure of the

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

Class II — Potential Health HazardTerminated
July 23, 2014· Zimmer, Inc.

Recalled Item: Double Offset Rasp Handle

The Issue: The firm received complaints for failure of the

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

Class II — Potential Health HazardTerminated
July 23, 2014· Zimmer, Inc.

Recalled Item: Double Offset Rasp Handle

The Issue: The firm received complaints for failure of the

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

Class II — Potential Health HazardTerminated
July 23, 2014· Zimmer, Inc.

Recalled Item: 23.5 Deg Rasp Handle Assy- RIGHT Nonsterile

The Issue: The firm received complaints for failure of the

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

Class II — Potential Health HazardTerminated
July 23, 2014· Zimmer, Inc.

Recalled Item: VI DBL OFFST W/ LRG STPL

The Issue: The firm received complaints for failure of the

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

Class II — Potential Health HazardTerminated
July 23, 2014· Zimmer, Inc.

Recalled Item: Double Offset Rasp Handle

The Issue: The firm received complaints for failure of the

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

Class II — Potential Health HazardTerminated
July 23, 2014· Zimmer, Inc.

Recalled Item: VER2 DBL OFFSET RASP HANDLE

The Issue: The firm received complaints for failure of the

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

Class II — Potential Health HazardTerminated
July 23, 2014· Zimmer, Inc.

Recalled Item: Double Offset Rasp Handle

The Issue: The firm received complaints for failure of the

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

Class II — Potential Health HazardTerminated
July 23, 2014· Zimmer, Inc.

Recalled Item: Double Offset Rasp Handle

The Issue: The firm received complaints for failure of the

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

Class II — Potential Health HazardTerminated
July 23, 2014· Zimmer, Inc.

Recalled Item: 23.5 Deg Rasp Handle Assy- LEFT Nonsterile

The Issue: The firm received complaints for failure of the

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

Class II — Potential Health HazardTerminated
July 23, 2014· Zimmer, Inc.

Recalled Item: VER2 HANDLE

The Issue: The firm received complaints for failure of the

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

Class II — Potential Health HazardTerminated
July 23, 2014· Zimmer, Inc.

Recalled Item: VER2 HANDLE

The Issue: The firm received complaints for failure of the

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

Class II — Potential Health HazardTerminated