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 38321–38340 of 38,428 recalls

June 1, 2009· Karl Storz Endoscopy America Inc

Recalled Item: Electrode

The Issue: damage to the sterile packaging (blister tray)

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

Class II — Potential Health HazardTerminated
June 1, 2009· Karl Storz Endoscopy America Inc

Recalled Item: Loop

The Issue: damage to the sterile packaging (blister tray)

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

Class II — Potential Health HazardTerminated
June 1, 2009· Karl Storz Endoscopy America Inc

Recalled Item: Electrode

The Issue: damage to the sterile packaging (blister tray)

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

Class II — Potential Health HazardTerminated
May 28, 2009· Alere San Diego, Inc.

Recalled Item: Triage TOX Drug Screen Panel

The Issue: Mislabeling

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

Class II — Potential Health HazardTerminated
April 17, 2009· Spinal Elements, Inc

Recalled Item: Mercury Spinal System DIA 5.5 x 50mm Straight Rod

The Issue: Spinal Elements has initiated a recall for the

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

Class III — Low RiskTerminated
April 17, 2009· Spinal Elements, Inc

Recalled Item: Mercury Spinal System DIA 5.5 x 110mm Straight Rod

The Issue: Spinal Elements has initiated a recall for the

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

Class III — Low RiskTerminated
April 17, 2009· Spinal Elements, Inc

Recalled Item: Mercury Spinal System DIA 5.5 x 40mm Straight Rod

The Issue: Spinal Elements has initiated a recall for the

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

Class III — Low RiskTerminated
April 17, 2009· Spinal Elements, Inc

Recalled Item: Mercury Spinal System DIA 5.5 x 30mm Straight Rod

The Issue: Spinal Elements has initiated a recall for the

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

Class III — Low RiskTerminated
April 17, 2009· Spinal Elements, Inc

Recalled Item: Mercury Spinal System DIA 5.5 x 70 MM Lordosed Rod

The Issue: Spinal Elements has initiated a recall for the

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

Class III — Low RiskTerminated
April 17, 2009· Spinal Elements, Inc

Recalled Item: Mercury Spinal System DIA 5.5 x 30 MM Lordosed Rod

The Issue: Spinal Elements has initiated a recall for the

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

Class III — Low RiskTerminated
April 17, 2009· Spinal Elements, Inc

Recalled Item: Mercury Spinal System DIA 5.5 x 60mm Straight Rod

The Issue: Spinal Elements has initiated a recall for the

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

Class III — Low RiskTerminated
April 17, 2009· Spinal Elements, Inc

Recalled Item: Mercury Spinal System DIA 5.5 x 400mm Straight Rod

The Issue: Spinal Elements has initiated a recall for the

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

Class III — Low RiskTerminated
April 17, 2009· Spinal Elements, Inc

Recalled Item: Mercury Spinal System DIA 5.5 x 50 MM Lordosed Rod

The Issue: Spinal Elements has initiated a recall for the

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

Class III — Low RiskTerminated
April 17, 2009· Spinal Elements, Inc

Recalled Item: Mercury Spinal System DIA 5.5 x 80mm Straight Rod

The Issue: Spinal Elements has initiated a recall for the

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

Class III — Low RiskTerminated
April 17, 2009· Spinal Elements, Inc

Recalled Item: Mercury Spinal System DIA 5.5 x 120mm Lordosed Rod

The Issue: Spinal Elements has initiated a recall for the

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

Class III — Low RiskTerminated
April 17, 2009· Spinal Elements, Inc

Recalled Item: Mercury Spinal System DIA 5.5 x 90mm Straight Rod

The Issue: Spinal Elements has initiated a recall for the

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

Class III — Low RiskTerminated
April 17, 2009· Spinal Elements, Inc

Recalled Item: Mercury Spinal System DIA 5.5 x 70mm Straight Rod

The Issue: Spinal Elements has initiated a recall for the

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

Class III — Low RiskTerminated
April 17, 2009· Spinal Elements, Inc

Recalled Item: Mercury Spinal System DIA 5.5 x 110mm Lordosed Rod

The Issue: Spinal Elements has initiated a recall for the

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

Class III — Low RiskTerminated
April 17, 2009· Spinal Elements, Inc

Recalled Item: Mercury Spinal System DIA 5.5 x 80 MM Lordosed Rod

The Issue: Spinal Elements has initiated a recall for the

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

Class III — Low RiskTerminated
April 17, 2009· Spinal Elements, Inc

Recalled Item: Mercury Spinal System DIA 5.5 x 100mm Straight Rod

The Issue: Spinal Elements has initiated a recall for the

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

Class III — Low RiskTerminated