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 26701–26720 of 38,428 recalls

July 11, 2016· Alere San Diego, Inc.

Recalled Item: Alere INRatio2 PT/INR Home Monitoring System Model Number: 0200432

The Issue: Alere San Diego is initiating a voluntary recall

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

Class I — Serious Health HazardTerminated
July 11, 2016· Alere San Diego, Inc.

Recalled Item: Alere INRatio PT/INR System Professional Model Numbers: 0100004 Product Usage:

The Issue: Alere San Diego is initiating a voluntary recall

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

Class I — Serious Health HazardTerminated
July 11, 2016· Ivoclar Vivadent, Inc.

Recalled Item: OptraPol Polishing Discs

The Issue: After a few seconds of polishing with moderate

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

Class II — Potential Health HazardTerminated
July 10, 2016· Trumpf Medical Systems, Inc.

Recalled Item: Operating Table TruSystem 7000 U

The Issue: Three complaints describing TruSystem tables unexpectedly descending approximate

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

Class II — Potential Health HazardTerminated
July 10, 2016· Trumpf Medical Systems, Inc.

Recalled Item: Mobile Column TruSystem 7500

The Issue: Three complaints describing TruSystem tables unexpectedly descending approximate

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

Class II — Potential Health HazardTerminated
July 10, 2016· Trumpf Medical Systems, Inc.

Recalled Item: Floor Mounting Column TS 7500 U

The Issue: Three complaints describing TruSystem tables unexpectedly descending approximate

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

Class II — Potential Health HazardTerminated
July 10, 2016· Trumpf Medical Systems, Inc.

Recalled Item: Stationary Column TruSystem 7599

The Issue: Three complaints describing TruSystem tables unexpectedly descending approximate

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

Class II — Potential Health HazardTerminated
July 8, 2016· Elekta, Inc.

Recalled Item: Medical Linear Accelerator

The Issue: There have been instances in hospitals where the

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

Class II — Potential Health HazardTerminated
July 8, 2016· Nakanishi Inc.

Recalled Item: Diamond Coated Tips and Burs are accessories to the air

The Issue: Through an error, the labeling failed to include

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

Class II — Potential Health HazardTerminated
July 8, 2016· Nakanishi Inc.

Recalled Item: Diamond Coated Tips and Burs are accessories to the Ultrasonic

The Issue: Through an error, the labeling failed to include

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

Class II — Potential Health HazardTerminated
July 8, 2016· Nakanishi Inc.

Recalled Item: Diamond Coated Tips and Burs are accessories to the air

The Issue: Through an error, the labeling failed to include

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

Class II — Potential Health HazardTerminated
July 8, 2016· Medtronic

Recalled Item: Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes 3" Item Code:...

The Issue: for compromise of the package resulting in

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

Class II — Potential Health HazardTerminated
July 8, 2016· Medtronic

Recalled Item: Valleylab Laparoscopic Wire J-Hook Electrode 36CM Item Code: E277236 The

The Issue: for compromise of the package resulting in

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

Class II — Potential Health HazardTerminated
July 8, 2016· Medtronic

Recalled Item: Valleylab Laparoscopic Flexible Laparoscopic Argon Blade Electrodes 28CM...

The Issue: for compromise of the package resulting in

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

Class II — Potential Health HazardTerminated
July 8, 2016· Medtronic

Recalled Item: Valleylab Laparoscopic Wire J-Hook Electrode 45CM Item Code: E277345 The

The Issue: for compromise of the package resulting in

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

Class II — Potential Health HazardTerminated
July 8, 2016· Medtronic

Recalled Item: Valleylab Laparoscopic Flat L-Hook Electrode 28cm Item Code: E278428 The

The Issue: for compromise of the package resulting in

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

Class II — Potential Health HazardTerminated
July 8, 2016· Medtronic

Recalled Item: Valleylab Laparoscopic Wire J-Hook Electrode 28CM Item Code: E278228 The

The Issue: for compromise of the package resulting in

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

Class II — Potential Health HazardTerminated
July 8, 2016· Medtronic

Recalled Item: Valleylab Laparoscopic Flat L-Hook Electrode Retractable Item Code:...

The Issue: for compromise of the package resulting in

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

Class II — Potential Health HazardTerminated
July 8, 2016· Medtronic

Recalled Item: Valleylab Laparoscopic Wire L-Hook Electrode Retractable Item Code:...

The Issue: for compromise of the package resulting in

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

Class II — Potential Health HazardTerminated
July 8, 2016· Medtronic

Recalled Item: Valleylab Laparoscopic Wire L-Hook Electrode Retractable Item Code:...

The Issue: for compromise of the package resulting in

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

Class II — Potential Health HazardTerminated