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 34881–34900 of 38,428 recalls

August 28, 2013· Zimmer, Inc.

Recalled Item: VerSys¿ Cemented Revision Calcar (CRC) Hip System Femoral Stems VerSys

The Issue: Based on a review of historic packaging validations,

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

Class II — Potential Health HazardTerminated
August 28, 2013· Zimmer, Inc.

Recalled Item: Ti-Magna Fx Washer Ti-Versa-FX¿II Femoral Fixation System S/C Plates The

The Issue: Zimmer recently conducted a review of historic packaging

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

Class II — Potential Health HazardTerminated
August 28, 2013· Globus Medical, Inc.

Recalled Item: Globus Medical MicroFuse Putty

The Issue: The sterility of this product to a Sterility

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

Class II — Potential Health HazardTerminated
August 28, 2013· GE Healthcare, LLC

Recalled Item: GE Healthcare

The Issue: GE Healthcare has recently become aware of a

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

Class I — Serious Health HazardTerminated
August 28, 2013· Camlog Usa

Recalled Item: C2244.4308 CONELOG Titanium Base CC ¿4.3GH2 0.8 inkl HS Product

The Issue: Product not cleared for sale/use in the United

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

Class II — Potential Health HazardTerminated
August 28, 2013· Camlog Usa

Recalled Item: C2244.5008 CONELOG Titanbasis CAD/CAM Conelog Titanium Base CAD/CAM Rx only

The Issue: Product not cleared for sale/use in the United

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

Class II — Potential Health HazardTerminated
August 28, 2013· Camlog Usa

Recalled Item: C2244.3820

The Issue: Product not cleared for sale/use in the United

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

Class II — Potential Health HazardTerminated
August 28, 2013· Camlog Usa

Recalled Item: C2244.3808

The Issue: Product not cleared for sale/use in the United

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

Class II — Potential Health HazardTerminated
August 28, 2013· Carefusion 2200 Inc

Recalled Item: *** 1) Cat. 4341B

The Issue: Catheters included in Thoracentesis Tray and Safe-T Thoracentesis

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

Class II — Potential Health HazardTerminated
August 27, 2013· Siemens Healthcare Diagnostics

Recalled Item: T3F

The Issue: Siemens Healthcare Diagnostics confirmed customer complaints regarding an

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

Class II — Potential Health HazardTerminated
August 27, 2013· Siemens Healthcare Diagnostics

Recalled Item: T3F

The Issue: Siemens Healthcare Diagnostics confirmed customer complaints regarding an

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

Class II — Potential Health HazardTerminated
August 27, 2013· Clark Laboratories, Inc. (dba,Trinity Biotech USA)

Recalled Item: Captia Syphilis-G Test Kit Product Usage: This is an enzyme

The Issue: Trinity Biotech recalled Trinity Biotech Captia Syphilis IgG

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

Class II — Potential Health HazardTerminated
August 27, 2013· Smith & Nephew Inc

Recalled Item: GENESIS(R) II

The Issue: The Tyvek(TM) lid on one, or both, of

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

Class II — Potential Health HazardTerminated
August 27, 2013· Smith & Nephew Inc

Recalled Item: GENESIS(R) II

The Issue: The Tyvek(TM) lid on one, or both, of

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

Class II — Potential Health HazardTerminated
August 27, 2013· Smith & Nephew Inc

Recalled Item: GENESIS(R) II

The Issue: The Tyvek(TM) lid on one, or both, of

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

Class II — Potential Health HazardTerminated
August 27, 2013· Smith & Nephew Inc

Recalled Item: GENESIS(R) II

The Issue: The Tyvek(TM) lid on one, or both, of

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

Class II — Potential Health HazardTerminated
August 27, 2013· Smith & Nephew Inc

Recalled Item: GENESIS(R) II

The Issue: The Tyvek(TM) lid on one, or both, of

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

Class II — Potential Health HazardTerminated
August 27, 2013· Smith & Nephew Inc

Recalled Item: GENESIS(R) II

The Issue: The Tyvek(TM) lid on one, or both, of

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

Class II — Potential Health HazardTerminated
August 27, 2013· H & H Associates

Recalled Item: H&H Emergency Cricothyrotomy Kit (Part No. HHECT01/ HHECTK01

The Issue: Medical device tubing used for endotracheal airway application

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

Class I — Serious Health HazardTerminated
August 26, 2013· Snug Seat Inc

Recalled Item: Crocodile (size 3) are two-armed

The Issue: The bolts, which secure the handles, on the

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

Class II — Potential Health HazardTerminated