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 34441–34460 of 38,428 recalls

November 4, 2013· Stryker Neurovascular

Recalled Item: Stryker brand SUPER COMPLIANT 4MM X 7MM

The Issue: Products were shipped labeled with "use by" dates

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

Class II — Potential Health HazardTerminated
November 4, 2013· Stryker Neurovascular

Recalled Item: Stryker brand EXCELSIOR SL-10 PRE-SHAPED 90 150CM

The Issue: Products were shipped labeled with "use by" dates

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

Class II — Potential Health HazardTerminated
November 4, 2013· Stryker Neurovascular

Recalled Item: Stryker brand COMPLIANT 4MM X 15MM

The Issue: Products were shipped labeled with "use by" dates

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

Class II — Potential Health HazardTerminated
November 4, 2013· Stryker Neurovascular

Recalled Item: Stryker brand EXCELSIOR 1018 PRE-SHAPED 45 150CM

The Issue: Products were shipped labeled with "use by" dates

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

Class II — Potential Health HazardTerminated
November 4, 2013· Stryker Neurovascular

Recalled Item: Stryker brand EXCELSIOR SL-10 PRE-SHAPED C 15OCM

The Issue: Products were shipped labeled with "use by" dates

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

Class II — Potential Health HazardTerminated
November 4, 2013· Lanx, Inc.

Recalled Item: LANX Timberline MPF Lateral Modular Plate Fixation System Straight Split

The Issue: Lanx, Inc. is recalling various lots of Timberline

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

Class II — Potential Health HazardTerminated
November 4, 2013· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Dekompressor Percutaneous Discectomy Probe. The Dekompressor is a single use

The Issue: Stryker has identified a potential for the auger

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

Class II — Potential Health HazardTerminated
November 1, 2013· SALTER LABS

Recalled Item: Salter Labs EtCO2 Sample line 15' (4.6 M) tube

The Issue: It has been determined that three lots of

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

Class II — Potential Health HazardTerminated
November 1, 2013· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Acetabular Pressurizer

The Issue: On March 14, 2013 a Work Order was

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

Class II — Potential Health HazardTerminated
October 31, 2013· Hospira Inc.

Recalled Item: Abbott Acclaim Infusion Pump Designed to deliver parenteral infusions including

The Issue: Hospira has received customer reports of broken door

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

Class I — Serious Health HazardTerminated
October 31, 2013· Hospira Inc.

Recalled Item: Hospira Acclaim Encore Infusion Pump Designed to deliver parenteral infusions

The Issue: Broken door assemblies on the Hospira/Abbott Acclaim Encore

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

Class I — Serious Health HazardTerminated
October 31, 2013· Zimmer, Inc.

Recalled Item: NexGen¿ Complete Knee Solutions Stemmed Tibial Component Precoat NexGen Tibial

The Issue: Two complaints were received in which it was

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

Class II — Potential Health HazardTerminated
October 30, 2013· ACUTE Innovations, LLC

Recalled Item: The ACUTE Innovations Modular RibLoc System (RibLoc U plus) is

The Issue: The ACUTE Innovations Ribloc U plus Rib Fracture

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

Class II — Potential Health HazardTerminated
October 30, 2013· Siemens Healthcare Diagnostics, Inc.

Recalled Item: Siemens CentraLink" Data Management System V14.0.4

The Issue: Under extremely rare circumstances, a patient result that

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

Class II — Potential Health HazardTerminated
October 30, 2013· Maquet Cardiovascular, LLC

Recalled Item: Vasoview Hemopro Endoscopic Vessel Harvesting System Maquet Cardiovascular...

The Issue: Maquet has received an increase in the number

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

Class II — Potential Health HazardTerminated
October 30, 2013· Philips Medical Systems, Inc.

Recalled Item: Easy Diagnost Eleva Universal Fluoroscopic applications

The Issue: The delivered application software was an outdated version

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

Class II — Potential Health HazardTerminated
October 30, 2013· Ergosafe Products LLC DBA Prism Medical Services USA

Recalled Item: Medcare Products Max-500 Stand

The Issue: The lift might fail with the labeled 500-lb

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

Class II — Potential Health HazardTerminated
October 30, 2013· Ergosafe Products LLC DBA Prism Medical Services USA

Recalled Item: Medcare Products Max-500 Stand-N-Weigh

The Issue: The lift might fail with the labeled 500-lb

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

Class II — Potential Health HazardTerminated
October 29, 2013· Kimberly-Clark Corporation

Recalled Item: Kimberly-Clark RadiOpaque Radiofrequency Cannula

The Issue: Product may contain a cannula with an active

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

Class II — Potential Health HazardTerminated
October 29, 2013· Orthofix, Inc

Recalled Item: Azure Anterior Cervical Plate System

The Issue: There is a possibility that the locking mechanism

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

Class II — Potential Health HazardTerminated