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 23381–23400 of 38,428 recalls

June 29, 2017· Sorin Group USA, Inc.

Recalled Item: NON-STERILE SAMPLE

The Issue: Medtronic informed LivaNova that some of their DLP

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

Class II — Potential Health HazardTerminated
June 29, 2017· Sorin Group USA, Inc.

Recalled Item: SORIN GROUP

The Issue: Medtronic informed LivaNova that some of their DLP

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

Class II — Potential Health HazardTerminated
June 29, 2017· Sorin Group USA, Inc.

Recalled Item: SORIN GROUP

The Issue: Medtronic informed LivaNova that some of their DLP

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

Class II — Potential Health HazardTerminated
June 29, 2017· Sorin Group USA, Inc.

Recalled Item: STERILE SAMPLE SORIN GROUP

The Issue: Medtronic informed LivaNova that some of their DLP

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

Class II — Potential Health HazardTerminated
June 29, 2017· Sorin Group USA, Inc.

Recalled Item: SORIN GROUP

The Issue: Medtronic informed LivaNova that some of their DLP

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

Class II — Potential Health HazardTerminated
June 29, 2017· Sorin Group USA, Inc.

Recalled Item: SORIN GROUP

The Issue: Medtronic informed LivaNova that some of their DLP

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

Class II — Potential Health HazardTerminated
June 28, 2017· GE Inspection Technologies, LP

Recalled Item: GE Inspection Technologies Blade|line Industrial Cabinet X-ray system

The Issue: GE Inspection Technologies, LP determined that the Blade|line

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

Class II — Potential Health HazardTerminated
June 27, 2017· Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables

Recalled Item: Safety-Deluxe Basic Soft Tissue Biopsy Tray without Biopsy Needle

The Issue: BD SafetyGlide Needle 22GA 1-1/2 inch may contain

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

Class II — Potential Health HazardTerminated
June 27, 2017· Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables

Recalled Item: Safety Deluxe Bone Marrow Biopsy/Aspiration Tray

The Issue: BD SafetyGlide Needle 22GA 1-1/2 inch may contain

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

Class II — Potential Health HazardTerminated
June 27, 2017· Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables

Recalled Item: Safety-Deluxe Lumbar Puncture Tray

The Issue: BD SafetyGlide Needle 22GA 1-1/2 inch may contain

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

Class II — Potential Health HazardTerminated
June 27, 2017· Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables

Recalled Item: Safety-Deluxe Lumbar Puncture Tray

The Issue: BD SafetyGlide Needle 22GA 1-1/2 inch may contain

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

Class II — Potential Health HazardTerminated
June 27, 2017· Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables

Recalled Item: Lumbar Puncture Tray

The Issue: BD SafetyGlide Needle 22GA 1-1/2 inch may contain

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

Class II — Potential Health HazardTerminated
June 27, 2017· Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables

Recalled Item: Safety Deluxe Bone Marrow Biopsy/ Aspiration Tray with Biopsy Needle

The Issue: BD SafetyGlide Needle 22GA 1-1/2 inch may contain

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

Class II — Potential Health HazardTerminated
June 27, 2017· Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables

Recalled Item: Laceration Tray

The Issue: BD SafetyGlide Needle 22GA 1-1/2 inch may contain

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

Class II — Potential Health HazardTerminated
June 27, 2017· Terumo Cardiovascular Systems Corporation

Recalled Item: TERUMO(R) Overpressure Safety Valve

The Issue: Terumo Cardiovascular Systems (Terumo CVS) has received reports

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

Class II — Potential Health HazardTerminated
June 27, 2017· Terumo Cardiovascular Systems Corporation

Recalled Item: Custom surgical kits containing TERUMO(R) Overpressure Safety Valve

The Issue: Terumo Cardiovascular Systems (Terumo CVS) has received reports

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

Class II — Potential Health HazardTerminated
June 27, 2017· NOVADAQ TECHNOLOGIES INC.

Recalled Item: NOVADAQ SPY-PHI Drape

The Issue: The sterile drape material may contain a pinhole

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

Class II — Potential Health HazardTerminated
June 27, 2017· NOVADAQ TECHNOLOGIES INC.

Recalled Item: NOVADAQ SPY-PHI PAQ Intended for use with the SPY-PHI System

The Issue: The sterile drape material may contain a pinhole

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

Class II — Potential Health HazardTerminated
June 27, 2017· NOVADAQ TECHNOLOGIES INC.

Recalled Item: NOVADAQ SPY-PHI Drape

The Issue: The sterile drape material may contain a pinhole

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

Class II — Potential Health HazardTerminated
June 27, 2017· Hologic, Inc

Recalled Item: Tomcat Instrument

The Issue: A Tomcat Instrument software anomaly that causes the

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

Class II — Potential Health HazardTerminated