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 8641–8660 of 38,428 recalls

March 1, 2023· Coloplast Manufacturing US, LLC

Recalled Item: Titan NB Scrotal Zero Ang 18cm

The Issue: A decrease in wall thickness has the potential

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

Class II — Potential Health HazardOngoing
March 1, 2023· Coloplast Manufacturing US, LLC

Recalled Item: Titan Touch NB Scrot Zero 18cm

The Issue: A decrease in wall thickness has the potential

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

Class II — Potential Health HazardOngoing
March 1, 2023· Coloplast Manufacturing US, LLC

Recalled Item: Titan Touch Scro Zero Ang 22cm

The Issue: A decrease in wall thickness has the potential

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

Class II — Potential Health HazardOngoing
March 1, 2023· Coloplast Manufacturing US, LLC

Recalled Item: Titan Touch Scro Zero Ang 20cm

The Issue: A decrease in wall thickness has the potential

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

Class II — Potential Health HazardOngoing
March 1, 2023· Covidien, LP

Recalled Item: Step Bladeless Trocars

The Issue: Medtronic was made aware of a supplier calibration

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

Class II — Potential Health HazardOngoing
March 1, 2023· Coloplast Manufacturing US, LLC

Recalled Item: Titan 0-Deg Scrotal 20 Cm

The Issue: XXX

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

Class II — Potential Health HazardOngoing
March 1, 2023· Coloplast Manufacturing US, LLC

Recalled Item: Titan Touch Scro Zero Ang 16cm

The Issue: A decrease in wall thickness has the potential

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

Class II — Potential Health HazardOngoing
March 1, 2023· Coloplast Manufacturing US, LLC

Recalled Item: Titan Touch NB Scrot Zero 16cm

The Issue: A decrease in wall thickness has the potential

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

Class II — Potential Health HazardOngoing
March 1, 2023· Shanghai United Imaging Healthcare Co., Ltd.

Recalled Item: Shanghai United Imaging Healthcare Co.

The Issue: Due to a software issue where the process

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

Class II — Potential Health HazardOngoing
March 1, 2023· Coloplast Manufacturing US, LLC

Recalled Item: Titan Touch Infr Zero Ang 18cm

The Issue: A decrease in wall thickness has the potential

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

Class II — Potential Health HazardOngoing
March 1, 2023· Covidien, LP

Recalled Item: Chromic Gut Absorbable Sutures

The Issue: Medtronic was made aware of a supplier calibration

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

Class II — Potential Health HazardOngoing
March 1, 2023· Coloplast Manufacturing US, LLC

Recalled Item: Titan Touch NB Infr Zero 16cm

The Issue: A decrease in wall thickness has the potential

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

Class II — Potential Health HazardOngoing
March 1, 2023· Coloplast Manufacturing US, LLC

Recalled Item: Titan 0-Deg Infrapubic 20 Cm

The Issue: A decrease in wall thickness has the potential

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

Class II — Potential Health HazardOngoing
March 1, 2023· Covidien, LP

Recalled Item: Plain Gut Absorbable Sutures

The Issue: Medtronic was made aware of a supplier calibration

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

Class II — Potential Health HazardOngoing
March 1, 2023· Coloplast Manufacturing US, LLC

Recalled Item: Titan Touch Infr Zero Ang 22cm

The Issue: A decrease in wall thickness has the potential

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

Class II — Potential Health HazardOngoing
March 1, 2023· Coloplast Manufacturing US, LLC

Recalled Item: Titan 0-Deg Scrotal 22 Cm

The Issue: A decrease in wall thickness has the potential

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

Class II — Potential Health HazardOngoing
March 1, 2023· Covidien, LP

Recalled Item: Mild Chromic Gut Absorbable Sutures

The Issue: Medtronic was made aware of a supplier calibration

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

Class II — Potential Health HazardOngoing
March 1, 2023· Coloplast Manufacturing US, LLC

Recalled Item: Titan Touch NB Infr Zero 18cm

The Issue: A decrease in wall thickness has the potential

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

Class II — Potential Health HazardOngoing
March 1, 2023· Coloplast Manufacturing US, LLC

Recalled Item: Titan 0-Deg Scrotal 18 Cm

The Issue: A decrease in wall thickness has the potential

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

Class II — Potential Health HazardOngoing
March 1, 2023· Coloplast Manufacturing US, LLC

Recalled Item: Titan Touch Pump

The Issue: A decrease in wall thickness has the potential

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

Class II — Potential Health HazardOngoing