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 17821–17840 of 38,428 recalls

May 1, 2019· Abbott Vascular

Recalled Item: Abbott MitraClip XTR Clip Delivery System

The Issue: Reports of implantable mitral valve repair system clips

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

Class II — Potential Health HazardTerminated
April 30, 2019· Beckman Coulter Inc.

Recalled Item: Beckman Coulter ACCESS Immunoassay Systems

The Issue: The recalling firm characterized the potential interference effects

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

Class II — Potential Health HazardTerminated
April 30, 2019· Beckman Coulter Inc.

Recalled Item: Beckman Coulter ACCESS Immunoassay Systems

The Issue: The recalling firm characterized the potential interference effects

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

Class II — Potential Health HazardTerminated
April 30, 2019· Beckman Coulter Inc.

Recalled Item: Beckman Coulter ACCESS Immunoassay Systems

The Issue: The recalling firm characterized the potential interference effects

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

Class II — Potential Health HazardTerminated
April 30, 2019· Beckman Coulter Inc.

Recalled Item: Beckman Coulter Access Immunoassay Systems

The Issue: The recalling firm characterized the potential interference effects

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

Class II — Potential Health HazardTerminated
April 30, 2019· Beckman Coulter Inc.

Recalled Item: Beckman Coulter ACCESS Immunoassay Systems

The Issue: The recalling firm characterized the potential interference effects

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

Class II — Potential Health HazardTerminated
April 30, 2019· Beckman Coulter Inc.

Recalled Item: Beckman Coulter Access Immunoassay Systems

The Issue: The recalling firm characterized the potential interference effects

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

Class II — Potential Health HazardTerminated
April 30, 2019· Cardinal Health 200, LLC

Recalled Item: Monoject Standard Hypodermic Needle

The Issue: Manufacturing defect was found for the cartridge component,

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

Class II — Potential Health HazardCompleted
April 30, 2019· Cardinal Health 200, LLC

Recalled Item: Monoject Standard Hypodermic Needle

The Issue: Manufacturing defect was found for the cartridge component,

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

Class II — Potential Health HazardCompleted
April 30, 2019· Cardinal Health 200, LLC

Recalled Item: Monoject Standard Hypodermic Needle Item code: 8881200029

The Issue: Manufacturing defect was found for the cartridge component,

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

Class II — Potential Health HazardCompleted
April 30, 2019· Cardinal Health 200, LLC

Recalled Item: Monoject Standard Hypodermic Needle

The Issue: Manufacturing defect was found for the cartridge component,

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

Class II — Potential Health HazardCompleted
April 30, 2019· Cardinal Health 200, LLC

Recalled Item: Monoject Blunt Cannula

The Issue: Manufacturing defect was found for the cartridge component,

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

Class II — Potential Health HazardCompleted
April 30, 2019· Cardinal Health 200, LLC

Recalled Item: Monoject Standard Hypodermic Needle

The Issue: Manufacturing defect was found for the cartridge component,

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

Class II — Potential Health HazardCompleted
April 30, 2019· Cardinal Health 200, LLC

Recalled Item: Monoject Blunt Cannula

The Issue: Manufacturing defect was found for the cartridge component,

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

Class II — Potential Health HazardCompleted
April 30, 2019· Cardinal Health 200, LLC

Recalled Item: Monoject 201 Vet Pak Hypodermic Needle

The Issue: Manufacturing defect was found for the cartridge component,

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

Class II — Potential Health HazardCompleted
April 30, 2019· Cardinal Health 200, LLC

Recalled Item: Monoject 201 Vet Pak Hypodermic Needle

The Issue: Manufacturing defect was found for the cartridge component,

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

Class II — Potential Health HazardCompleted
April 30, 2019· Cardinal Health 200, LLC

Recalled Item: Monoject 201 Vet Pak Hypodermic Needle

The Issue: Manufacturing defect was found for the cartridge component,

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

Class II — Potential Health HazardCompleted
April 30, 2019· Cardinal Health 200, LLC

Recalled Item: Monoject Blunt Cannula

The Issue: Manufacturing defect was found for the cartridge component,

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

Class II — Potential Health HazardCompleted
April 30, 2019· Cardinal Health 200, LLC

Recalled Item: Monoject Blunt Cannula

The Issue: Manufacturing defect was found for the cartridge component,

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

Class II — Potential Health HazardCompleted
April 30, 2019· Cardinal Health 200, LLC

Recalled Item: Monoject 201 Vet Pak Hypodermic Needle

The Issue: Manufacturing defect was found for the cartridge component,

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

Class II — Potential Health HazardCompleted