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 19541–19560 of 38,428 recalls

October 2, 2018· Zimmer Biomet, Inc.

Recalled Item: Affixus Hip Fracture Nail Left 125 Deg 11x300mm

The Issue: The set screw is not able to advance

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

Class II — Potential Health HazardTerminated
October 2, 2018· Zimmer Biomet, Inc.

Recalled Item: Affixus Hip Fracture Nail 125 Deg 10x165mm

The Issue: The set screw is not able to advance

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

Class II — Potential Health HazardTerminated
October 2, 2018· Zimmer Biomet, Inc.

Recalled Item: Affixus Hip Fracture Nail Left Deg 9x300mm

The Issue: The set screw is not able to advance

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

Class II — Potential Health HazardTerminated
October 2, 2018· Zimmer Biomet, Inc.

Recalled Item: Affixus Hip Fracture Nail 130 Deg 12x165mm

The Issue: The set screw is not able to advance

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

Class II — Potential Health HazardTerminated
October 2, 2018· Straumann Manufacturing, Inc.

Recalled Item: Neodent¿ GM Mini Conical Abutment - Product Usage: Mini Conical

The Issue: Laser engraved label does not match with the

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

Class II — Potential Health HazardTerminated
October 2, 2018· Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Recalled Item: Medtronic CareLink Encore 29901 Programmer

The Issue: Vulnerabilities have been identified in the SDN download

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

Class II — Potential Health HazardOngoing
October 2, 2018· Randox Laboratories Ltd.

Recalled Item: Liquid Cardiac Control

The Issue: Randox has previously issued a recall for Liquid

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

Class II — Potential Health HazardTerminated
October 2, 2018· Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Recalled Item: Medtronic CareLink 2090 Programmer

The Issue: Vulnerabilities have been identified in the SDN download

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

Class II — Potential Health HazardOngoing
October 2, 2018· Randox Laboratories Ltd.

Recalled Item: Liquid Cardiac Control

The Issue: Randox has previously issued a recall for Liquid

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

Class II — Potential Health HazardTerminated
October 1, 2018· Medical Components, Inc dba MedComp

Recalled Item: C3 Wave App

The Issue: When the iPad is updated with Apple iOS

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

Class II — Potential Health HazardTerminated
October 1, 2018· Comet Technologies Usa Inc

Recalled Item: YXLON Cougar Cabinet X-Ray System Product Usage: The products are

The Issue: Failure to meet the requirement of the performance

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

Class II — Potential Health HazardTerminated
October 1, 2018· Comet Technologies Usa Inc

Recalled Item: YXLON Cheetah cabinet X-Ray System Product Usage: The products are

The Issue: Failure to meet the requirement of the performance

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

Class II — Potential Health HazardTerminated
October 1, 2018· Mevion Medical Systems, Inc.

Recalled Item: MEVION S250i

The Issue: Treatment is allowed to continue (via partials) in

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

Class II — Potential Health HazardTerminated
October 1, 2018· SVS LLC

Recalled Item: PremierPro Aluminum Adjustable Walker

The Issue: This recall is due to a mandated order

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

Class II — Potential Health HazardTerminated
October 1, 2018· LeMaitre Vascular, Inc.

Recalled Item: LeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying Carotid Shunt

The Issue: Pouches from this lot are not sealed compromising

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

Class II — Potential Health HazardTerminated
September 28, 2018· Paragon 28, Inc.

Recalled Item: P28

The Issue: Mislabeling

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

Class II — Potential Health HazardTerminated
September 28, 2018· TriMed Inc.

Recalled Item: TriMed Countersink 1.7mm

The Issue: The epoxy on Apex manufactured epoxy-coated instruments can

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

Class II — Potential Health HazardOngoing
September 28, 2018· TriMed Inc.

Recalled Item: TriMed Peg Guide Extender

The Issue: The spring on the PEG-Extender can rust due

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

Class II — Potential Health HazardOngoing
September 28, 2018· TriMed Inc.

Recalled Item: TriMed Locking Drill Guide

The Issue: The epoxy on Apex manufactured epoxy-coated instruments can

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

Class II — Potential Health HazardOngoing
September 28, 2018· TriMed Inc.

Recalled Item: TriMed Hex Driver 1.2

The Issue: The epoxy on Apex manufactured epoxy-coated instruments can

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

Class II — Potential Health HazardOngoing