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 34261–34280 of 38,428 recalls

November 22, 2013· Smiths Medical ASD, Inc.

Recalled Item: 4043G-2: 3 mL Line Draw

The Issue: issue with the plunger tip of the Portex¿

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

Class II — Potential Health HazardTerminated
November 22, 2013· Smiths Medical ASD, Inc.

Recalled Item: 4043E: 3 mL Line Draw

The Issue: issue with the plunger tip of the Portex¿

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

Class II — Potential Health HazardTerminated
November 22, 2013· Smiths Medical ASD, Inc.

Recalled Item: 4042E: 3 mL Line Draw

The Issue: issue with the plunger tip of the Portex¿

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

Class II — Potential Health HazardTerminated
November 22, 2013· Smiths Medical ASD, Inc.

Recalled Item: G1762: 3 mL Line Draw

The Issue: issue with the plunger tip of the Portex¿

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

Class II — Potential Health HazardTerminated
November 22, 2013· Smiths Medical ASD, Inc.

Recalled Item: G1725: 3 mL Line Draw

The Issue: issue with the plunger tip of the Portex¿

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

Class II — Potential Health HazardTerminated
November 22, 2013· Smiths Medical ASD, Inc.

Recalled Item: G1469J: 3 mL Line Draw

The Issue: issue with the plunger tip of the Portex¿

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

Class II — Potential Health HazardTerminated
November 22, 2013· Smiths Medical ASD, Inc.

Recalled Item: 4040-2: Umbilical 3 mL Line Draw

The Issue: issue with the plunger tip of the Portex¿

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

Class II — Potential Health HazardTerminated
November 22, 2013· Smiths Medical ASD, Inc.

Recalled Item: 4043W-2: 3 mL Line Draw

The Issue: issue with the plunger tip of the Portex¿

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

Class II — Potential Health HazardTerminated
November 22, 2013· Smiths Medical ASD, Inc.

Recalled Item: 4043-2: 3 mL Line Draw

The Issue: issue with the plunger tip of the Portex¿

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

Class II — Potential Health HazardTerminated
November 22, 2013· Bio-Rad Laboratories, Inc.

Recalled Item: D-10 Dual Program

The Issue: D-10 A1c Dual Program Floppy was programmed incorrectly

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

Class III — Low RiskTerminated
November 22, 2013· CryoLife, Inc.

Recalled Item: Pulmonary Hemi-Artery SG Used in heart surgery

The Issue: Serological testing for the donor was performed with

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

Class II — Potential Health HazardTerminated
November 22, 2013· Smiths Medical ASD, Inc.

Recalled Item: Medfusion¿ 4000 Syringe Infusion Pumps Medfusion¿ 4000 Syringe Infusion Pumps

The Issue: Smiths Medical is conducting a recall involving all

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

Class II — Potential Health HazardTerminated
November 21, 2013· Neuro Kinetics, Inc.

Recalled Item: Normative Data Template CD for use with the I-Portal devices. Used to measure

The Issue: The data provided on the Normative Data Template

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

Class II — Potential Health HazardTerminated
November 21, 2013· Horiba Instruments, Inc dba Horiba Medical

Recalled Item: ABX PENTRA N Control

The Issue: Horiba Medical is recalling the ABX PENTRA N

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

Class II — Potential Health HazardTerminated
November 21, 2013· Medrad Mr Inc

Recalled Item: Medrad Veris MR Monitor units The system is intended to

The Issue: The main board, P/N 301641, installed in some

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

Class II — Potential Health HazardTerminated
November 21, 2013· Remel Inc

Recalled Item: Oxoid Antimicrobial Susceptibility Testing Disc

The Issue: Individual discs in the lot may not be

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

Class II — Potential Health HazardTerminated
November 21, 2013· Welch Allyn Protocol, Inc

Recalled Item: The Propaq LT Series monitors. Model numbers 802LTAN

The Issue: Welch Allyn will update Propaq 802 Series Vital

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

Class II — Potential Health HazardTerminated
November 21, 2013· Steris Corporation

Recalled Item: SYSTEM 1E Liquid Chemical Sterilant Processing System

The Issue: Customers indicated fluctuations in environmental conditions sites and

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

Class II — Potential Health HazardTerminated
November 21, 2013· Ziehm Imaging Inc

Recalled Item: Ziehm Vision(2) C-Arm Interventional Fluoroscopic X-Ray System. Mobile...

The Issue: Engineering change in 2006 resulted in a minor

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

Class II — Potential Health HazardTerminated
November 21, 2013· Ziehm Imaging Inc

Recalled Item: Ziehm Vista/Vista Plus C-Arm Interventional Fluoroscopic X-Ray System....

The Issue: Engineering change in 2006 resulted in a minor

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

Class II — Potential Health HazardTerminated