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 21501–21520 of 38,428 recalls

March 22, 2018· Volcano Corporation

Recalled Item: Philips Volcano CORE M2 Vascular System

The Issue: The incorrect resistor has been used in affected

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

Class II — Potential Health HazardTerminated
March 22, 2018· Cook Inc.

Recalled Item: Cook Vacuum Pump (Cook Aspiration Unit) K-MAR-5200-US

The Issue: Pump was found to be constructed from crimp

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

Class II — Potential Health HazardTerminated
March 22, 2018· Cook Inc.

Recalled Item: Cook Vacuum Pump ( Cook Aspiration Unit) K-MAR-5200-US

The Issue: Pump was found to be constructed from crimp

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

Class II — Potential Health HazardTerminated
March 22, 2018· Becton Dickinson & Company

Recalled Item: BD Vacutainer¿ Lithium Heparin Green Top Tube

The Issue: BD Vacutainer EDTA Lavender, Tan, and Pink Top

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

Class I — Serious Health HazardTerminated
March 22, 2018· Becton Dickinson & Company

Recalled Item: BD Vacutainer¿ EDTA Pink Top Tube

The Issue: BD Vacutainer EDTA Lavender, Tan, and Pink Top

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

Class I — Serious Health HazardTerminated
March 22, 2018· Becton Dickinson & Company

Recalled Item: BD Vacutainer¿ EDTA Tan Top Tube

The Issue: BD Vacutainer EDTA Lavender, Tan, and Pink Top

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

Class I — Serious Health HazardTerminated
March 22, 2018· Becton Dickinson & Company

Recalled Item: BD Vacutainer¿ EDTA Lavender Top Tubes: Catalog Numbers: 1. 366401

The Issue: BD Vacutainer EDTA Lavender, Tan, and Pink Top

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

Class I — Serious Health HazardTerminated
March 21, 2018· Bard Medical Division

Recalled Item: Bard Midstream Urine Collector with Rigid Funnel and Iodophor Prep

The Issue: Medline notified BMD that the Aplicare Povidone Iodine

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

Class II — Potential Health HazardTerminated
March 21, 2018· Siemens Healthcare Diagnostics, Inc.

Recalled Item: Dimension Vista¿ MULTI 1 SDIL

The Issue: The diluent may have an incomplete slit on

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

Class II — Potential Health HazardTerminated
March 21, 2018· Siemens Healthcare Diagnostics, Inc.

Recalled Item: Dimension Vista¿ MULTI 2 SDIL

The Issue: The diluent may have an incomplete slit on

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

Class II — Potential Health HazardTerminated
March 21, 2018· Siemens Healthcare Diagnostics, Inc.

Recalled Item: Dimension Vista¿ CTNI Sample Diluent

The Issue: The diluent may have an incomplete slit on

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

Class II — Potential Health HazardTerminated
March 21, 2018· Madison Polymeric Engineering

Recalled Item: First Step Endoscopic Cleaning Pad

The Issue: The products exhibit an unpleasant odor due to

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

Class II — Potential Health HazardTerminated
March 21, 2018· Madison Polymeric Engineering

Recalled Item: Travel Kit

The Issue: The products exhibit an unpleasant odor due to

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

Class II — Potential Health HazardTerminated
March 21, 2018· Madison Polymeric Engineering

Recalled Item: First Step Endoscopic Cleaning Pad

The Issue: The products exhibit an unpleasant odor due to

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

Class II — Potential Health HazardTerminated
March 21, 2018· Madison Polymeric Engineering

Recalled Item: First Step Endoscopic Cleaning Pad

The Issue: The products exhibit an unpleasant odor due to

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

Class II — Potential Health HazardTerminated
March 21, 2018· Madison Polymeric Engineering

Recalled Item: First Step Endoscopic Cleaning Pad with 4" Button Brush

The Issue: The products exhibit an unpleasant odor due to

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

Class II — Potential Health HazardTerminated
March 21, 2018· Madison Polymeric Engineering

Recalled Item: Draco Enzymatic Deep-Cleaning Pad

The Issue: The products exhibit an unpleasant odor due to

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

Class II — Potential Health HazardTerminated
March 20, 2018· Epic Extremity, LLC

Recalled Item: Epic Extremity Plate System

The Issue: There is an error in the caddy artwork

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

Class II — Potential Health HazardTerminated
March 20, 2018· Epic Extremity, LLC

Recalled Item: Epic Extremity Plate System

The Issue: There is an error in the caddy artwork

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

Class II — Potential Health HazardTerminated
March 20, 2018· Becton Dickinson & Company

Recalled Item: BD Vacutainer¿ Ultra TouchTM Push Button Blood Collection Set 0.6

The Issue: Products do not meet the labeled sterility claim

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

Class II — Potential Health HazardTerminated