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 31461–31480 of 38,428 recalls

November 21, 2014· Teleflex, Inc.

Recalled Item: Bronchial One Lumen Tube - Left

The Issue: Customer complaints reporting that the cobb connector detached

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

Class II — Potential Health HazardTerminated
November 21, 2014· Teleflex, Inc.

Recalled Item: Bronchial Double Lumen Tube Set (Left)

The Issue: Customer complaints reporting that the cobb connector detached

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

Class II — Potential Health HazardTerminated
November 21, 2014· Teleflex, Inc.

Recalled Item: Bronchial One Lumen Tube - Right

The Issue: Customer complaints reporting that the cobb connector detached

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

Class II — Potential Health HazardTerminated
November 21, 2014· Teleflex, Inc.

Recalled Item: Tracheopart Set (Right)

The Issue: Customer complaints reporting that the cobb connector detached

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

Class II — Potential Health HazardTerminated
November 21, 2014· Teleflex, Inc.

Recalled Item: Bronchial Double Lumen Tube Set (Left)

The Issue: Customer complaints reporting that the cobb connector detached

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

Class II — Potential Health HazardTerminated
November 21, 2014· Teleflex, Inc.

Recalled Item: White Bronchial Double Lumen Tube Set (Right) Sterile

The Issue: Customer complaints reporting that the cobb connector detached

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

Class II — Potential Health HazardTerminated
November 21, 2014· Teleflex, Inc.

Recalled Item: Tracheopart Set (Left)

The Issue: Customer complaints reporting that the cobb connector detached

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

Class II — Potential Health HazardTerminated
November 21, 2014· Becton Dickinson & Co.

Recalled Item: BBL Port A Cul tubes with Swabs Sterile Pack

The Issue: The products may exhibit indications of excessive oxidation

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

Class II — Potential Health HazardTerminated
November 21, 2014· Becton Dickinson & Co.

Recalled Item: BBL Port A Cul tubes

The Issue: The products may exhibit indications of excessive oxidation

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

Class II — Potential Health HazardTerminated
November 21, 2014· Express Diagnostics Int'l., Inc.

Recalled Item: DrugCheck Ketamine Dip Test 31317-3P PRO-EU-SWE

The Issue: This recall has been initiated due to potential

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

Class II — Potential Health HazardTerminated
November 21, 2014· Smiths Medical ASD, Inc.

Recalled Item: Hypodermic Needle Pro¿ Edge" Safety Device 20G x1

The Issue: Needle is not captured in the needle safety

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

Class II — Potential Health HazardCompleted
November 21, 2014· Atricure Inc

Recalled Item: Cryogenic probe for cardiac ablation surgery

The Issue: Affected product may have compromised sterility due to

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

Class II — Potential Health HazardTerminated
November 21, 2014· Smiths Medical ASD, Inc.

Recalled Item: Hypodermic Needle Pro¿ Edge" Safety Device with Syringe 20G x1

The Issue: Needle is not captured in the needle safety

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

Class II — Potential Health HazardCompleted
November 21, 2014· Instrumentation Laboratory Co.

Recalled Item: HemosIL PT-Fibrinogen HS PLUS

The Issue: Some vials of HemosIL PT-Fibrinogen HS PLUS, Part

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

Class II — Potential Health HazardTerminated
November 21, 2014· Smiths Medical ASD, Inc.

Recalled Item: Hypodermic Needle Pro¿ Edge" Safety Device with Syringe 20G x1

The Issue: Needle is not captured in the needle safety

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

Class II — Potential Health HazardCompleted
November 21, 2014· Intuitive Surgical, Inc.

Recalled Item: Fluorescence Imaging Procedure Kit

The Issue: The storage conditions for indocyanine green (ICG) are

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

Class II — Potential Health HazardTerminated
November 21, 2014· Intuitive Surgical, Inc.

Recalled Item: Fluorescence Imaging Procedure Kit

The Issue: The storage conditions for indocyanine green (ICG) are

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

Class II — Potential Health HazardTerminated
November 21, 2014· Zimmer Manufacturing B.V.

Recalled Item: Bone Screw

The Issue: Analysis of returned complaint devices, product in inventory,

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

Class II — Potential Health HazardTerminated
November 21, 2014· TomoTherapy Incorporated

Recalled Item: TomoTherapy Treatment System with software versions 2.0.1 / 2.0.2 /

The Issue: Accuray has become aware of a potential safety

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

Class II — Potential Health HazardTerminated
November 20, 2014· Philips Medical Systems, Inc.

Recalled Item: Lithium Polymer Fiber Optic Module Batteries used in the Intera

The Issue: VCG battery ignited in a VCG unit when

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

Class II — Potential Health HazardTerminated