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 19561–19580 of 38,428 recalls

September 28, 2018· TriMed Inc.

Recalled Item: TriMed Wrist Hook Dorsal Impactor

The Issue: The WHD/WHV impactors can rust over time due

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

Class II — Potential Health HazardOngoing
September 28, 2018· Tosoh Bioscience Inc

Recalled Item: AIA-2000 Analyzer

The Issue: Tosoh Bioscience has become aware of a potential

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

Class II — Potential Health HazardTerminated
September 28, 2018· Tosoh Bioscience Inc

Recalled Item: AIA-900Analyzer

The Issue: Tosoh Bioscience has become aware of a potential

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

Class II — Potential Health HazardTerminated
September 28, 2018· Tosoh Bioscience Inc

Recalled Item: AIA-2000 Analyzer

The Issue: There is a possibility that the liquid suction

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

Class II — Potential Health HazardTerminated
September 28, 2018· Tosoh Bioscience Inc

Recalled Item: Tosoh AIA-900 immunoassay Analyzer

The Issue: A software issue may cause the liquid volume

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

Class II — Potential Health HazardTerminated
September 28, 2018· Siemens Healthcare Diagnostics, Inc.

Recalled Item: Dimension Thermal Chamber Motor Cable located in the following models:

The Issue: Thermal chamber motors have electrical cables with single

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

Class II — Potential Health HazardTerminated
September 28, 2018· Siemens Medical Solutions USA, Inc.

Recalled Item: Biograph mCT: a) S(64)-3R

The Issue: The terminals on the plug may become loose

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

Class II — Potential Health HazardTerminated
September 28, 2018· Siemens Medical Solutions USA, Inc.

Recalled Item: Biograph Horizon a) 3R

The Issue: The terminals on the plug may become loose

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

Class II — Potential Health HazardTerminated
September 27, 2018· Orthofix Srl

Recalled Item: ORTHOFIX Catalogue Number:

The Issue: As a result of complaint investigations it was

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

Class II — Potential Health HazardTerminated
September 27, 2018· Orthofix Srl

Recalled Item: ORTHOFIX Catalogue Number:

The Issue: As a result of complaint investigations it was

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

Class II — Potential Health HazardTerminated
September 27, 2018· Orthofix Srl

Recalled Item: ORTHOFIX Catalogue Number:

The Issue: As a result of complaint investigations it was

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

Class II — Potential Health HazardTerminated
September 27, 2018· Orthofix Srl

Recalled Item: ORTHOFIX Catalogue Number:

The Issue: As a result of complaint investigations it was

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

Class II — Potential Health HazardTerminated
September 27, 2018· Orthofix Srl

Recalled Item: ORTHOFIX Catalogue Number:

The Issue: As a result of complaint investigations it was

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

Class II — Potential Health HazardTerminated
September 27, 2018· Orthofix Srl

Recalled Item: ORTHOFIX Catalogue Number:

The Issue: As a result of complaint investigations it was

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

Class II — Potential Health HazardTerminated
September 27, 2018· Orthofix Srl

Recalled Item: ORTHOFIX Catalogue Number:

The Issue: As a result of complaint investigations it was

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

Class II — Potential Health HazardTerminated
September 27, 2018· Orthofix Srl

Recalled Item: ORTHOFIX Catalogue Number:

The Issue: As a result of complaint investigations it was

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

Class II — Potential Health HazardTerminated
September 27, 2018· Orthofix Srl

Recalled Item: ORTHOFIX Catalogue Number:

The Issue: As a result of complaint investigations it was

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

Class II — Potential Health HazardTerminated
September 27, 2018· Orthofix Srl

Recalled Item: ORTHOFIX Catalogue Number:

The Issue: As a result of complaint investigations it was

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

Class II — Potential Health HazardTerminated
September 27, 2018· Orthofix Srl

Recalled Item: ORTHOFIX Catalogue Number:

The Issue: As a result of complaint investigations it was

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

Class II — Potential Health HazardTerminated
September 27, 2018· Orthofix Srl

Recalled Item: ORTHOFIX Catalogue Number:

The Issue: As a result of complaint investigations it was

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

Class II — Potential Health HazardTerminated