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 26901–26920 of 38,428 recalls

June 16, 2016· Ab Sciex

Recalled Item: AB SCIEX 3200MD QTRAP¿ LC/MS/MS System Mass Spectrometer for In-Vitro

The Issue: MultiQuant MD software where under certain conditions a

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

Class II — Potential Health HazardTerminated
June 16, 2016· Ab Sciex

Recalled Item: AB SCIEX Triple Quad 4500MD LC/MS/MS System. Mass Spectrometer for

The Issue: MultiQuant MD software where under certain conditions a

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

Class II — Potential Health HazardTerminated
June 16, 2016· Halyard Health, Inc

Recalled Item: Coolife Sinergy Radiofrequency Kit

The Issue: Mismatch between the length of the RF electrode

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

Class II — Potential Health HazardTerminated
June 16, 2016· Stryker Instruments Div. of Stryker Corporation

Recalled Item: 6.0mm Round Fluted Bur

The Issue: Foreign Object Contamination

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

Class II — Potential Health HazardTerminated
June 16, 2016· Medtronic Inc., Cardiac Rhythm and Heart Failure

Recalled Item: Medtronic

The Issue: This Pacing Lead System does not comply with

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

Class II — Potential Health HazardTerminated
June 16, 2016· Stryker Instruments Div. of Stryker Corporation

Recalled Item: 5.0mm Round Fluted Bur

The Issue: Foreign Object Contamination

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

Class II — Potential Health HazardTerminated
June 15, 2016· Handicare AB

Recalled Item: EVA Floor Lifts

The Issue: After feedback from customers and internal suspicion, Handicare

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

Class II — Potential Health HazardOngoing
June 15, 2016· Boston Scientific Corporation

Recalled Item: Pacemakers: Accolade MRI DR Model L311

The Issue: Five Accolate MRI and Essentio MRI DR pulse

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

Class II — Potential Health HazardTerminated
June 15, 2016· Mindray DS USA, Inc. dba Mindray North America

Recalled Item: A7 Anesthesia Delivery System

The Issue: for a leak to occur on the

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

Class II — Potential Health HazardTerminated
June 15, 2016· Smith & Nephew, Inc.

Recalled Item: Smith and Nephew TWINFIX QUICK-T Knot Pusher Suture Cutter

The Issue: The device could be subject to breaches of

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

Class II — Potential Health HazardTerminated
June 15, 2016· The Anspach Effort, Inc.

Recalled Item: Anspach G1 High Speed Electric Handpiece Air Cooled (eG1A) Use

The Issue: The graphics at the attachment interface indicating locked

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

Class II — Potential Health HazardTerminated
June 14, 2016· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Stryker AutoPlex System. Model Numbers 0607-687-000

The Issue: The Piston Head can become separated from the

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

Class II — Potential Health HazardTerminated
June 14, 2016· Hill-Rom, Inc.

Recalled Item: Volker 2080

The Issue: The current construction of the side rail latch

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

Class II — Potential Health HazardTerminated
June 14, 2016· WalkMed Infusion, LLC

Recalled Item: The pump (with cushioning foam inserts) is packaged in a

The Issue: WalkMed Infusion, LLC Announces a Voluntary Field Action

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

Class II — Potential Health HazardTerminated
June 14, 2016· WalkMed Infusion, LLC

Recalled Item: T095-120 IV Set with 1.2 Micron Filter. Packaged in a Tyvek pouch

The Issue: WalkMed Infusion, LLC Announces a Voluntary Field Action

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

Class II — Potential Health HazardTerminated
June 14, 2016· WalkMed Infusion, LLC

Recalled Item: T100-022WF

The Issue: WalkMed Infusion, LLC Announces a Voluntary Field Action

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

Class II — Potential Health HazardTerminated
June 14, 2016· WalkMed Infusion, LLC

Recalled Item: T105-000WC IV Set w/2 Y-Sites

The Issue: WalkMed Infusion, LLC Announces a Voluntary Field Action

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

Class II — Potential Health HazardTerminated
June 14, 2016· WalkMed Infusion, LLC

Recalled Item: The pump (with cushioning foam inserts) is packaged in a

The Issue: WalkMed Infusion, LLC Announces a Voluntary Field Action

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

Class II — Potential Health HazardTerminated
June 14, 2016· WalkMed Infusion, LLC

Recalled Item: T090-000 90" 20 Drop IV Admin Set. Packaged in a Tyvek pouch

The Issue: WalkMed Infusion, LLC Announces a Voluntary Field Action

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

Class II — Potential Health HazardTerminated
June 14, 2016· WalkMed Infusion, LLC

Recalled Item: T100-000WF

The Issue: WalkMed Infusion, LLC Announces a Voluntary Field Action

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

Class II — Potential Health HazardTerminated