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 24161–24180 of 38,428 recalls

April 27, 2017· AbbVie Inc.

Recalled Item: AbbVie PEG

The Issue: PEG kits have the potential for one of

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

Class II — Potential Health HazardTerminated
April 27, 2017· Randox Laboratories

Recalled Item: Liquid Urine Control Level 3 For Professional Use in the

The Issue: According to Randox Laboratories an investigation indicates a

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

Class III — Low RiskTerminated
April 27, 2017· AbbVie Inc.

Recalled Item: AbbVie PEG Recalled by AbbVie Inc. Due to

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

Class II — Potential Health HazardTerminated
April 27, 2017· AbbVie Inc.

Recalled Item: AbbVie PEG

The Issue: PEG kits have the potential for one of

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

Class II — Potential Health HazardTerminated
April 26, 2017· Ortho-Clinical Diagnostics

Recalled Item: enGen Track System with TCAutomation Software Version 4.2

The Issue: A software anomaly with TCA Software V4.2 may

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

Class II — Potential Health HazardTerminated
April 26, 2017· Iba Dosimetry

Recalled Item: Large Stealth Chamber

The Issue: When the Stealth Chamber is used as a

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

Class II — Potential Health HazardTerminated
April 26, 2017· Zimmer Biomet, Inc.

Recalled Item: Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System

The Issue: Zimmer Biomet is conducting a voluntary recall for

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

Class II — Potential Health HazardTerminated
April 26, 2017· Abbott Vascular

Recalled Item: Absorb Bioresorbable Vascular Scaffold (BVS) system (Australia). The Absorb BVS

The Issue: Abbott Vascular is initiating a recall of the

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

Class I — Serious Health HazardTerminated
April 26, 2017· Stryker Howmedica Osteonics Corp.

Recalled Item: Hoffmann LRF Safety Clip (Bone Transport Strut)

The Issue: Stryker is recalling Hoffmann LRF (Limb Reconstruction Frame)

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

Class II — Potential Health HazardTerminated
April 25, 2017· Medistim Asa

Recalled Item: MEDISTIM VERIQ SYSTEM

The Issue: A system component overheated causing melting of the

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

Class II — Potential Health HazardTerminated
April 25, 2017· Zimmer Biomet, Inc.

Recalled Item: Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee.

The Issue: A custom implant manufactured entirely from titanium for

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

Class II — Potential Health HazardTerminated
April 25, 2017· Vascular Solutions, Inc.

Recalled Item: Venture RX Catheter

The Issue: Vascular Solutions, Inc. (VSI) is voluntarily removing all

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

Class I — Serious Health HazardTerminated
April 25, 2017· Cook Inc.

Recalled Item: Clarke-Reich Laparoscopic Knot Pusher

The Issue: reprocessing instructions do not provide sufficient detailed information

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

Class II — Potential Health HazardTerminated
April 25, 2017· Cook Inc.

Recalled Item: Stamey Needle

The Issue: reprocessing instructions do not provide sufficient detailed information

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

Class II — Potential Health HazardTerminated
April 25, 2017· Cook Inc.

Recalled Item: Endoscopic Introducer/Extractor

The Issue: reprocessing instructions do not provide sufficient detailed information

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

Class II — Potential Health HazardTerminated
April 25, 2017· Cook Inc.

Recalled Item: Pereyra-Raz Ligature Carrier

The Issue: reprocessing instructions do not provide sufficient detailed information

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

Class II — Potential Health HazardTerminated
April 25, 2017· Cook Inc.

Recalled Item: Pereyra Ligature Carrier 75

The Issue: reprocessing instructions do not provide sufficient detailed information

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

Class II — Potential Health HazardTerminated
April 25, 2017· Invacare Corporation

Recalled Item: Assist Bed Rail - 6632

The Issue: A typographical error was noted within the user

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

Class II — Potential Health HazardTerminated
April 25, 2017· Bard Access Systems Inc.

Recalled Item: StatLock¿ IV Premium Catheter Stabilization Device

The Issue: StatLockTM IV Premium Catheter Stabilization Device may contain

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

Class II — Potential Health HazardTerminated
April 25, 2017· BioMerieux SA

Recalled Item: ETEST ETP32 (Ertapenem) Ref. 531640

The Issue: False susceptible results

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

Class II — Potential Health HazardTerminated