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 37981–38000 of 38,428 recalls

February 5, 2012· Hospira Inc.

Recalled Item: Plum A+3 Infusion Pump System

The Issue: Hospira has received reports of distal pressure sensor

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

Class II — Potential Health HazardTerminated
February 5, 2012· Hospira Inc.

Recalled Item: Plum A+ Hyperbaric Infusion Pump

The Issue: Hospira has received reports of distal pressure sensor

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

Class II — Potential Health HazardTerminated
February 5, 2012· Hospira Inc.

Recalled Item: Plum A+ Infusion Pump

The Issue: Hospira has received reports of distal pressure sensor

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

Class II — Potential Health HazardTerminated
February 5, 2012· Hospira Inc.

Recalled Item: Plum A+ Infusion Pump

The Issue: Hospira has received reports of distal pressure sensor

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

Class II — Potential Health HazardTerminated
February 4, 2012· Orthosensor

Recalled Item: "****ORTHO SENSOR**12-123-A Knee Trial for Trithion***1560 Saw grass...

The Issue: Ortho sensor in Sunrise, FL is recalling the

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

Class II — Potential Health HazardTerminated
February 1, 2012· Roche Molecular Systems, Inc.

Recalled Item: COBAS AmpliPrep Sample Tube Input Barcode Clips

The Issue: Certain lots of COBAS AmpliPrep (CAP) S-tube Input

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

Class II — Potential Health HazardTerminated
February 1, 2012· Abbott Point Of Care Inc.

Recalled Item: i-Stat BNP cartridges Abbott Point of Care Inc. The i-Stat

The Issue: The frequency of suppressed results for i-Stat cTnl,

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

Class II — Potential Health HazardTerminated
February 1, 2012· Abbott Point Of Care Inc.

Recalled Item: i-Stat CK-MP cartridges Abbott Point of Care Inc. The i-Stat

The Issue: The frequency of suppressed results for i-Stat cTnl,

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

Class II — Potential Health HazardTerminated
February 1, 2012· Abbott Point Of Care Inc.

Recalled Item: i-Stat cTnl cartridges Abbott Point of Care Inc. The i-Stat

The Issue: The frequency of suppressed results for i-Stat cTnl,

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

Class II — Potential Health HazardTerminated
January 31, 2012· Abbott Molecular

Recalled Item: Abbott Molecular Bar Code Scanner User's Guide

The Issue: In the Abbott Molecular Bar Code Scanner User's

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

Class II — Potential Health HazardTerminated
January 27, 2012· Beckman Coulter Inc.

Recalled Item: IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent

The Issue: The recall was initiated because Beckman Coulter has

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

Class II — Potential Health HazardTerminated
January 26, 2012· Stryker Howmedica Osteonics Corp.

Recalled Item: Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH

The Issue: Stryker has become aware that there exists a

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

Class II — Potential Health HazardTerminated
January 24, 2012· Exactech, Inc.

Recalled Item: ***NOVATION MODULAR DRILL BIT LENGTH: 30mm

The Issue: Exactech Inc. of Gainesville, FL is recalling their

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

Class II — Potential Health HazardTerminated
January 24, 2012· Exactech, Inc.

Recalled Item: ***NOVATION MODULAR DRILL BIT LENGTH: 40mm

The Issue: Exactech Inc. of Gainesville, FL is recalling their

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

Class II — Potential Health HazardTerminated
January 24, 2012· Exactech, Inc.

Recalled Item: ***NOVATION MODULAR DRILL BIT LENGTH: 20mm

The Issue: Exactech Inc. of Gainesville, FL is recalling their

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

Class II — Potential Health HazardTerminated
January 24, 2012· Exactech, Inc.

Recalled Item: ***NOVATION MODULAR DRILL BIT LENGTH: 40mm

The Issue: Exactech Inc. of Gainesville, FL is recalling their

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

Class II — Potential Health HazardTerminated
January 24, 2012· Exactech, Inc.

Recalled Item: ***NOVATION MODULAR DRILL BIT LENGTH: 20mm

The Issue: Exactech Inc. of Gainesville, FL is recalling their

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

Class II — Potential Health HazardTerminated
January 24, 2012· Exactech, Inc.

Recalled Item: ***NOVATION MODULAR DRILL BIT LENGTH: 30mm

The Issue: Exactech Inc. of Gainesville, FL is recalling their

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

Class II — Potential Health HazardTerminated
January 23, 2012· GE Healthcare, LLC

Recalled Item: VMX

The Issue: GE Healthcare has become aware of an issue

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

Class II — Potential Health HazardTerminated
January 20, 2012· Beckman Coulter Inc.

Recalled Item: Active Renin IRMA Kit

The Issue: The recall was initiated because Beckman Coulter has

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

Class II — Potential Health HazardTerminated