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 30541–30560 of 38,428 recalls

April 20, 2015· Stradis Healthcare, LLC.

Recalled Item: Breast Augmentation Pack and Breast Augmentation Expanded Pack - contains

The Issue: Convenience kits being recalled due to the recall

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

Class II — Potential Health HazardCompleted
April 20, 2015· Stradis Healthcare, LLC.

Recalled Item: Gyn Pack - contains Devon Light Glove Used during surgery

The Issue: Convenience kits being recalled due to the recall

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

Class II — Potential Health HazardCompleted
April 20, 2015· Stradis Healthcare, LLC.

Recalled Item: Set Up Pack - contains Devon Light Glove Used during surgery

The Issue: Convenience kits being recalled due to the recall

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

Class II — Potential Health HazardCompleted
April 20, 2015· Stradis Healthcare, LLC.

Recalled Item: Bariatric Pack - contains Devon Light Glove Used during surgery

The Issue: Convenience kits being recalled due to the recall

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

Class II — Potential Health HazardCompleted
April 20, 2015· Stradis Healthcare, LLC.

Recalled Item: Neurosurgery Pack - contains Devon Light Glove Used during surgery

The Issue: Convenience kits being recalled due to the recall

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

Class II — Potential Health HazardCompleted
April 20, 2015· Stradis Healthcare, LLC.

Recalled Item: Orthopedic Split Drape Pack - contains Devon Light Glove Used during surgery

The Issue: Convenience kits being recalled due to the recall

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

Class II — Potential Health HazardCompleted
April 20, 2015· Stradis Healthcare, LLC.

Recalled Item: Eye Pack - contains Devon Light Glove Used during surgery

The Issue: Convenience kits being recalled due to the recall

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

Class II — Potential Health HazardCompleted
April 20, 2015· Stradis Healthcare, LLC.

Recalled Item: Abdominal Pack and Abdom Pack - contains Devon Light Glove Used during surgery

The Issue: Convenience kits being recalled due to the recall

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

Class II — Potential Health HazardCompleted
April 20, 2015· Compass Health Brands

Recalled Item: Roscoe Mini Neb Compressor User Manual for the NEB-ROS Product

The Issue: Roscoe Medical has recently identified the need to

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

Class II — Potential Health HazardTerminated
April 20, 2015· Siemens Healthcare Diagnostics, Inc.

Recalled Item: Dimension Vista Systems LOCI Thyroid Stimulating Hormone

The Issue: Dimension Vista LOCI Thyroid Stimulating Hormone (TSH) Lot

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

Class II — Potential Health HazardTerminated
April 20, 2015· Siemens Medical Solutions USA, Inc

Recalled Item: SOMATOM Emotion 6

The Issue: Software bugs in VC20B SP0a or SP1 software

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

Class II — Potential Health HazardTerminated
April 20, 2015· Siemens Medical Solutions USA, Inc

Recalled Item: SOMATOM Emotion 16

The Issue: Software bugs in VC20B SP0a or SP1 software

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

Class II — Potential Health HazardTerminated
April 20, 2015· Siemens Medical Solutions USA, Inc

Recalled Item: SOMATOM Perspective

The Issue: Software bugs in VC20B SP0a or SP1 software

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

Class II — Potential Health HazardTerminated
April 20, 2015· ICU Medical, Inc.

Recalled Item: 98" (249 cm) Transfer Set w/MicroClave T-Connector

The Issue: ICU Medical is recalling MicroClave T-Connectors because they

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

Class II — Potential Health HazardTerminated
April 20, 2015· ICU Medical, Inc.

Recalled Item: 107" (272 cm) Ext Set w/2 Check Valves

The Issue: ICU Medical is recalling MicroClave T-Connectors because they

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

Class II — Potential Health HazardTerminated
April 20, 2015· ICU Medical, Inc.

Recalled Item: 113" (287cm) Transfer Set w/MicroClave T-Connector

The Issue: ICU Medical is recalling MicroClave T-Connectors because they

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

Class II — Potential Health HazardTerminated
April 20, 2015· ICU Medical, Inc.

Recalled Item: 104" (264 cm) Transfer Set w/MicroClave T-Connector

The Issue: ICU Medical is recalling MicroClave T-Connectors because they

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

Class II — Potential Health HazardTerminated
April 20, 2015· ICU Medical, Inc.

Recalled Item: 127" (323cm) Transfer Set w/Check Valve

The Issue: ICU Medical is recalling MicroClave T-Connectors because they

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

Class II — Potential Health HazardTerminated
April 20, 2015· ICU Medical, Inc.

Recalled Item: 108" (274 cm) Transfer Set w/Check Valve

The Issue: ICU Medical is recalling MicroClave T-Connectors because they

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

Class II — Potential Health HazardTerminated
April 20, 2015· ICU Medical, Inc.

Recalled Item: 119" (302 cm) Transfer Set w/MicroClave T-Connector

The Issue: ICU Medical is recalling MicroClave T-Connectors because they

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

Class II — Potential Health HazardTerminated