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 29321–29340 of 38,428 recalls

August 26, 2015· Edwards Lifesciences, LLC

Recalled Item: ThruPort Knot Pusher. This device is sold individually (Model KP1)

The Issue: The configuration of the slot at the tip

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

Class II — Potential Health HazardTerminated
August 25, 2015· Collagen Matrix Inc

Recalled Item: NuOSS Cancellous Intended for use in dental surgery.

The Issue: On 8/25/2015, Collagen Matrix, Inc discovered that one

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

Class II — Potential Health HazardTerminated
August 25, 2015· Resource Optimization & Innovation Llc

Recalled Item: Regard

The Issue: Custom surgical kits contain a component (ORS fluid

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

Class II — Potential Health HazardTerminated
August 25, 2015· Resource Optimization & Innovation Llc

Recalled Item: Regard

The Issue: Custom surgical kits contain a component (ORS fluid

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

Class II — Potential Health HazardTerminated
August 25, 2015· Resource Optimization & Innovation Llc

Recalled Item: Regard Custom Surgical Pack

The Issue: The kits contain pressure monitoring kits or sets

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

Class II — Potential Health HazardTerminated
August 25, 2015· Resource Optimization & Innovation Llc

Recalled Item: Regard

The Issue: Custom surgical kits contain a component (ORS fluid

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

Class II — Potential Health HazardTerminated
August 25, 2015· Resource Optimization & Innovation Llc

Recalled Item: Regard

The Issue: Custom surgical kits contain a component (ORS fluid

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

Class II — Potential Health HazardTerminated
August 25, 2015· Resource Optimization & Innovation Llc

Recalled Item: Regard

The Issue: Custom surgical kits contain a component (ORS fluid

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

Class II — Potential Health HazardTerminated
August 25, 2015· Resource Optimization & Innovation Llc

Recalled Item: Regard

The Issue: Custom surgical kits contain a component (ORS fluid

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

Class II — Potential Health HazardTerminated
August 25, 2015· Resource Optimization & Innovation Llc

Recalled Item: Regard

The Issue: Custom surgical kits contain a component (ORS fluid

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

Class II — Potential Health HazardTerminated
August 25, 2015· Resource Optimization & Innovation Llc

Recalled Item: Regard

The Issue: Custom surgical kits contain a component (ORS fluid

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

Class II — Potential Health HazardTerminated
August 25, 2015· Cardinal Health

Recalled Item: Ambitex NMD400 Nitrile Exam Gloves size medium. General Hospital and

The Issue: Ambitex Nitrile NMD400 Exam Gloves size medium on

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

Class II — Potential Health HazardTerminated
August 25, 2015· Boston Scientific Corporation

Recalled Item: Boston Scientific

The Issue: Cross-threading of the hemostasis valve may occur if

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

Class II — Potential Health HazardTerminated
August 25, 2015· Boston Scientific Corporation

Recalled Item: Boston Scientific

The Issue: Cross-threading of the hemostasis valve may occur if

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

Class II — Potential Health HazardTerminated
August 24, 2015· Perkin Elmer Life Sciences Inc

Recalled Item: Perkin Elmer Specimen Gate

The Issue: It would be possible for an abnormal analytical

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

Class II — Potential Health HazardTerminated
August 24, 2015· Teleflex Medical

Recalled Item: Rusch Flexi-slip tracheal tube Stylet

The Issue: Due to reports of the plastic coating of

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

Class II — Potential Health HazardTerminated
August 24, 2015· Teleflex Medical

Recalled Item: R¿sch Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip

The Issue: Due to reports of the plastic coating of

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

Class II — Potential Health HazardTerminated
August 24, 2015· STERILMED, INC.

Recalled Item: Zimmer

The Issue: Mislabeling

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

Class II — Potential Health HazardTerminated
August 24, 2015· Siemens Healthcare Diagnostics Inc

Recalled Item: Siemens RAPIDPoint 500 Measurement Cartridge Lactate (750 tests) Part Number:

The Issue: RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through

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

Class II — Potential Health HazardTerminated
August 24, 2015· Terumo Cardiovascular Systems Corp

Recalled Item: Terumo Custom Cardiovascular Procedure Kit Tubing Pack P/N: 66041-1 Terumo

The Issue: Custom Cardiovascular Procedure Kits contain recalled component Medivators

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

Class II — Potential Health HazardTerminated