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 35341–35360 of 38,428 recalls

June 14, 2013· Biomerieux Inc

Recalled Item: bioMerieux Vitek 2 Systems Software version 6.01 software

The Issue: A product issue has been identified for customers

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

Class II — Potential Health HazardTerminated
June 14, 2013· Biomerieux Inc

Recalled Item: bioMerieux Vitek 2 Systems Software version 6.01 software

The Issue: A product issue has been identified for customers

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

Class II — Potential Health HazardTerminated
June 13, 2013· Becton Dickinson & Co.

Recalled Item: BD Affirm VPIII Microbial Identification Tests

The Issue: In vitro diagnostic test kit may exhibit invalid

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

Class II — Potential Health HazardTerminated
June 13, 2013· GE Healthcare, LLC

Recalled Item: Elscint APEX Helix

The Issue: GE became aware of an incident at a

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

Class I — Serious Health HazardTerminated
June 13, 2013· GE Healthcare, LLC

Recalled Item: Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640

The Issue: GE became aware of an incident at a

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

Class I — Serious Health HazardTerminated
June 13, 2013· GE Healthcare, LLC

Recalled Item: Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging...

The Issue: GE became aware of an incident at a

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

Class I — Serious Health HazardTerminated
June 13, 2013· GE Healthcare, LLC

Recalled Item: GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The

The Issue: GE became aware of an incident at a

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

Class I — Serious Health HazardTerminated
June 13, 2013· GE Healthcare, LLC

Recalled Item: Brivo NM615

The Issue: GE became aware of an incident at a

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

Class I — Serious Health HazardTerminated
June 13, 2013· GE Healthcare, LLC

Recalled Item: GE Healthcare Infinia Hawkeye 4 Option For Dual-Head Variable Angle Gamma Camera

The Issue: GE became aware of an incident at a

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

Class I — Serious Health HazardTerminated
June 13, 2013· GE Healthcare, LLC

Recalled Item: Discovery NM 630

The Issue: GE became aware of an incident at a

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

Class I — Serious Health HazardTerminated
June 12, 2013· Ortho-Clinical Diagnostics

Recalled Item: VITROS Chemistry Products PROT Slides packaged as 90 slides/pack catalog

The Issue: Ortho Clinical Diagnostics is recalling Slide Dispense cartridges

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

Class II — Potential Health HazardTerminated
June 12, 2013· Ortho-Clinical Diagnostics

Recalled Item: VITROS Chemistry Products SALI Slides packaged as 90 slides/pack catalog

The Issue: Ortho Clinical Diagnostics is recalling Slide Dispense cartridges

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

Class II — Potential Health HazardTerminated
June 12, 2013· Ortho-Clinical Diagnostics

Recalled Item: VITROS Chemistry Products ALKP Slides

The Issue: Ortho Clinical Diagnostics is recalling Slide Dispense cartridges

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

Class II — Potential Health HazardTerminated
June 12, 2013· Ortho-Clinical Diagnostics

Recalled Item: VITROS Chemistry Products PHOS Slides packaged as 300 slides/pack catalog

The Issue: Ortho Clinical Diagnostics is recalling Slide Dispense cartridges

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

Class II — Potential Health HazardTerminated
June 12, 2013· Ortho-Clinical Diagnostics

Recalled Item: VITROS Chemistry Products AMYL Slides packaged as 300 slides/pack catalog

The Issue: Ortho Clinical Diagnostics is recalling Slide Dispense cartridges

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

Class II — Potential Health HazardTerminated
June 12, 2013· Ortho-Clinical Diagnostics

Recalled Item: VITROS Chemistry Products ALB Slides

The Issue: Ortho Clinical Diagnostics is recalling Slide Dispense cartridges

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

Class II — Potential Health HazardTerminated
June 12, 2013· Ortho-Clinical Diagnostics

Recalled Item: VITROS Chemistry Products Li Slides packaged as 300 slides/pack catalog

The Issue: Ortho Clinical Diagnostics is recalling Slide Dispense cartridges

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

Class II — Potential Health HazardTerminated
June 12, 2013· Ortho-Clinical Diagnostics

Recalled Item: VITROS Chemistry Products Mg Slides packaged as 300 slides/pack catalog

The Issue: Ortho Clinical Diagnostics is recalling Slide Dispense cartridges

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

Class II — Potential Health HazardTerminated
June 12, 2013· Ortho-Clinical Diagnostics

Recalled Item: VITROS Chemistry Products DGXN Slides packaged as 90 slides/pack catalog

The Issue: Ortho Clinical Diagnostics is recalling Slide Dispense cartridges

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

Class II — Potential Health HazardTerminated
June 12, 2013· Ortho-Clinical Diagnostics

Recalled Item: VITROS Chemistry Products TBIL Slides packaged as 300 slides/pack catalog

The Issue: Ortho Clinical Diagnostics is recalling Slide Dispense cartridges

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

Class II — Potential Health HazardTerminated