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 35381–35400 of 38,428 recalls

June 12, 2013· Ortho-Clinical Diagnostics

Recalled Item: VITROS Chemistry Products CRBM 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 TRIG 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 BUN/UREA 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 dHDL 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 PHBR 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 AST 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 LAC 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· Accelerated Care Plus Corporation

Recalled Item: Omnicycle Elite

The Issue: An anomaly in the firmware that may cause

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

Class II — Potential Health HazardTerminated
June 12, 2013· Physio Control, Inc.

Recalled Item: The LIFEPAK 500 Automated External Defibrillator is a semi-automatic...

The Issue: The LIFEPAK 500 Automated External Defibrillator (AED) could

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

Class II — Potential Health HazardTerminated
June 12, 2013· Synthes USA HQ, Inc.

Recalled Item: Synthes CMF Distraction System The product is intended for use

The Issue: The firm initiated a voluntary recall of the

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

Class II — Potential Health HazardTerminated
June 12, 2013· Medtronic Inc. Cardiac Rhythm Disease Management

Recalled Item: Medtronic

The Issue: Mislabeling

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

Class II — Potential Health HazardTerminated
June 11, 2013· GE Healthcare It

Recalled Item: The Centricity PACS Workstation is intended for use as a

The Issue: GE has recently become aware of potential issues

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

Class II — Potential Health HazardTerminated
June 11, 2013· Integra LifeSciences Corp.

Recalled Item: Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain

The Issue: Integra LifeSciences Corporation has determined that there is

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

Class II — Potential Health HazardTerminated
June 11, 2013· Integra LifeSciences Corp.

Recalled Item: Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen

The Issue: Integra LifeSciences Corporation has determined that there is

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

Class II — Potential Health HazardTerminated
June 11, 2013· Integra LifeSciences Corp.

Recalled Item: Inegra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain

The Issue: Integra LifeSciences Corporation has determined that there is

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

Class II — Potential Health HazardTerminated
June 11, 2013· Integra LifeSciences Corp.

Recalled Item: Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain

The Issue: Integra LifeSciences Corporation has determined that there is

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

Class II — Potential Health HazardTerminated
June 11, 2013· Integra LifeSciences Corp.

Recalled Item: Integra Licox Brain Tissue Oxygen Monitoring

The Issue: Integra LifeSciences Corporation has determined that there is

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

Class II — Potential Health HazardTerminated
June 11, 2013· Integra LifeSciences Corp.

Recalled Item: Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen

The Issue: Integra LifeSciences Corporation has determined that there is

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

Class II — Potential Health HazardTerminated
June 11, 2013· Integra LifeSciences Corp.

Recalled Item: Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain

The Issue: Integra LifeSciences Corporation has determined that there is

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

Class II — Potential Health HazardTerminated
June 11, 2013· Integra LifeSciences Corp.

Recalled Item: Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain

The Issue: Integra LifeSciences Corporation has determined that there is

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

Class II — Potential Health HazardTerminated