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 24941–24960 of 38,428 recalls

February 7, 2017· LeMaitre Vascular, Inc.

Recalled Item: LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer...

The Issue: The Contains Latex symbol was not printed onto

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

Class II — Potential Health HazardTerminated
February 7, 2017· LeMaitre Vascular, Inc.

Recalled Item: LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter (eIFU) REF# e2401-50

The Issue: The Contains Latex symbol was not printed onto

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

Class II — Potential Health HazardTerminated
February 7, 2017· LeMaitre Vascular, Inc.

Recalled Item: LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF#

The Issue: The Contains Latex symbol was not printed onto

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

Class II — Potential Health HazardTerminated
February 7, 2017· LeMaitre Vascular, Inc.

Recalled Item: LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter with Introducer...

The Issue: The Contains Latex symbol was not printed onto

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

Class II — Potential Health HazardTerminated
February 7, 2017· LeMaitre Vascular, Inc.

Recalled Item: LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter (paper IFU)

The Issue: The Contains Latex symbol was not printed onto

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

Class II — Potential Health HazardTerminated
February 7, 2017· LeMaitre Vascular, Inc.

Recalled Item: LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF#

The Issue: The Contains Latex symbol was not printed onto

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

Class II — Potential Health HazardTerminated
February 7, 2017· LeMaitre Vascular, Inc.

Recalled Item: LeMaitre Vascular Reddick Cholangiogram Catheter (eIFU) REF# e2400-50

The Issue: The Contains Latex symbol was not printed onto

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

Class II — Potential Health HazardTerminated
February 7, 2017· LeMaitre Vascular, Inc.

Recalled Item: LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer...

The Issue: The Contains Latex symbol was not printed onto

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

Class II — Potential Health HazardTerminated
February 7, 2017· LeMaitre Vascular, Inc.

Recalled Item: LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter (eIFU) REF# e2400-51

The Issue: The Contains Latex symbol was not printed onto

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

Class II — Potential Health HazardTerminated
February 6, 2017· GE Healthcare, LLC

Recalled Item: Table Patient Step on RFX/SFX

The Issue: Reported incidents of a patient step detaching from

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

Class II — Potential Health HazardTerminated
February 3, 2017· Siemens Medical Solutions USA, Inc

Recalled Item: Artis zee

The Issue: Failures can result due to a component defect

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

Class II — Potential Health HazardTerminated
February 3, 2017· CORPAK MedSystems, Inc.

Recalled Item: CORFLO PEG Kit

The Issue: Firm is initiating voluntary correction of CORFLO PEG

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

Class II — Potential Health HazardTerminated
February 3, 2017· CORPAK MedSystems, Inc.

Recalled Item: CORFLO

The Issue: Firm is initiating voluntary correction of CORFLO PEG

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

Class II — Potential Health HazardTerminated
February 3, 2017· CORPAK MedSystems, Inc.

Recalled Item: CORFLO

The Issue: Firm is initiating voluntary correction of CORFLO PEG

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

Class II — Potential Health HazardTerminated
February 3, 2017· Heartware

Recalled Item: HeartWare HVAD System Controller The HeartWare Ventricular Assist System (VAS

The Issue: Product recall of all HVAD Controllers currently on

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

Class I — Serious Health HazardOngoing
February 2, 2017· Elcam Medical, Inc.

Recalled Item: Elcam Minimal Residual Volume Luer-activated Swabable-stockcock (MRVLS) 4w...

The Issue: The stopcock was found to have punctures

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

Class II — Potential Health HazardTerminated
February 2, 2017· CP Medical Inc

Recalled Item: PGCL [poly (glycolide-co-caprolactone)] Absorbable Suture

The Issue: The tensile strength minimum as directed by USP

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

Class II — Potential Health HazardOngoing
February 2, 2017· Siemens Healthcare Diagnostics, Inc.

Recalled Item: ADVIA Centaur XPT System Software Versions V1.0.1

The Issue: Multiple software issues, which may affect the operation

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

Class II — Potential Health HazardTerminated
February 2, 2017· Smith & Nephew, Inc.

Recalled Item: Smith & Nephew Dyonics Saw Blade

The Issue: The single use devices are provided sterile and

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

Class II — Potential Health HazardTerminated
February 2, 2017· Smith & Nephew, Inc.

Recalled Item: Smith & Nephew Dyonics Saw Blade

The Issue: The single use devices are provided sterile and

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

Class II — Potential Health HazardTerminated