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 21061–21080 of 38,428 recalls

May 2, 2018· Galt Medical Corporation

Recalled Item: 1) ELITE HV

The Issue: The products listed might contain unsafe levels of

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

Class II — Potential Health HazardTerminated
May 2, 2018· Galt Medical Corporation

Recalled Item: TVS LPA

The Issue: The products listed might contain unsafe levels of

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

Class II — Potential Health HazardTerminated
May 2, 2018· Galt Medical Corporation

Recalled Item: 1) Vascular Dilator

The Issue: The products listed might contain unsafe levels of

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

Class II — Potential Health HazardTerminated
May 2, 2018· Ad-Tech Medical Instrument Corporation

Recalled Item: AD-TECH Medical Instrument Corporation Drill Sleeve Guides DSG-6-3-090-2.4N...

The Issue: The diameter of the drill sleeve guide raw

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

Class II — Potential Health HazardTerminated
May 2, 2018· The Seaberg Company Inc

Recalled Item: Part #: SAM XT-M

The Issue: Based on internal testing, results indicated a possible

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

Class II — Potential Health HazardTerminated
May 2, 2018· The Seaberg Company Inc

Recalled Item: Part #: SAM XT-C

The Issue: Based on internal testing, results indicated a possible

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

Class II — Potential Health HazardTerminated
May 2, 2018· The Seaberg Company Inc

Recalled Item: Part #: SAM XT-C

The Issue: Based on internal testing, results indicated a possible

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

Class II — Potential Health HazardTerminated
May 2, 2018· Fresenius Medical Care Renal Therapies Group, LLC

Recalled Item: NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis

The Issue: Mislabeling

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

Class II — Potential Health HazardTerminated
May 2, 2018· Roche Molecular Systems, Inc.

Recalled Item: MagNA Pure 24 System

The Issue: Cross-contamination of samples has been reported when running

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

Class II — Potential Health HazardTerminated
May 2, 2018· Heartware

Recalled Item: Heartware Medtronic HVAD System for cardiac use. Including the following

The Issue: transient electrical connection interruption between an HVAD

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

Class I — Serious Health HazardOngoing
May 2, 2018· Smith & Nephew, Inc.

Recalled Item: smith&nephew ANTHOLOGY POROUS HIGH OFFSET STEM

The Issue: Three lots of Anthology HO Porous size 7

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

Class II — Potential Health HazardTerminated
May 1, 2018· Siemens Medical Solutions USA, Inc

Recalled Item: Artis Q.zen floor

The Issue: After the Large Display returns from power save

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

Class II — Potential Health HazardTerminated
May 1, 2018· Siemens Medical Solutions USA, Inc

Recalled Item: Artis Q.zeego

The Issue: After the Large Display returns from power save

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

Class II — Potential Health HazardTerminated
May 1, 2018· Siemens Medical Solutions USA, Inc

Recalled Item: Artis Q biplane

The Issue: After the Large Display returns from power save

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

Class II — Potential Health HazardTerminated
May 1, 2018· Siemens Medical Solutions USA, Inc

Recalled Item: Artis Q ceiling

The Issue: After the Large Display returns from power save

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

Class II — Potential Health HazardTerminated
May 1, 2018· Siemens Medical Solutions USA, Inc

Recalled Item: ARTIS Pheno Interventional Fluoroscopic X-Ray System

The Issue: If the C-arm is manually moved in the

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

Class II — Potential Health HazardCompleted
May 1, 2018· Siemens Medical Solutions USA, Inc

Recalled Item: Artis zee biplane MN

The Issue: After the Large Display returns from power save

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

Class II — Potential Health HazardTerminated
May 1, 2018· Siemens Medical Solutions USA, Inc

Recalled Item: Artis zeego

The Issue: After the Large Display returns from power save

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

Class II — Potential Health HazardTerminated
May 1, 2018· Philips Medical Systems Nederlands

Recalled Item: OmniDiagnost-Eleva X-ray system Angiographic and Diagnostic

The Issue: The fixation of the upper and lower tilt

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

Class II — Potential Health HazardTerminated
May 1, 2018· Siemens Medical Solutions USA, Inc

Recalled Item: Artis zee MP

The Issue: After the Large Display returns from power save

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

Class II — Potential Health HazardTerminated