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 37241–37260 of 38,428 recalls

August 13, 2012· GE Healthcare, LLC

Recalled Item: GE Healthcare

The Issue: GE Healthcare became aware of a potential issue

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

Class II — Potential Health HazardTerminated
August 13, 2012· Mindray DS USA, Inc. d.b.a. Mindray North America

Recalled Item: Mindray A5 Anesthesia Delivery System Manufactured in China for Mindray

The Issue: Mindray has identified the potential for a system

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

Class I — Serious Health HazardTerminated
August 13, 2012· Mindray DS USA, Inc. d.b.a. Mindray North America

Recalled Item: Mindray A3 Anesthesia Delivery System Manufactured in China for Mindray

The Issue: Mindray has identified the potential for a system

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

Class I — Serious Health HazardTerminated
August 13, 2012· Vital Images, Inc.

Recalled Item: Software for Vitrea

The Issue: Vital Images has found two potential errors in

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

Class II — Potential Health HazardTerminated
August 13, 2012· Neomend Inc

Recalled Item: Progel Pleural Air Leak Sealant

The Issue: Product was distributed with an incorrect expiration date

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

Class II — Potential Health HazardTerminated
August 10, 2012· CEFLA DENTAL GROUP

Recalled Item: MyRay RXDC dental unit x-ray unit

The Issue: The RX DC dental x-ray unit was found

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

Class II — Potential Health HazardTerminated
August 10, 2012· Immunodiagnostics Systems Ltd

Recalled Item: IDS-iSYS N-Mid¿ Osteocalcin

The Issue: It has been noted by staff at IDS

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

Class II — Potential Health HazardTerminated
August 10, 2012· Immunodiagnostics Systems Ltd

Recalled Item: IDS Urine BETA CrossLaps ELISA

The Issue: It has been noted by staff at IDS

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

Class II — Potential Health HazardTerminated
August 10, 2012· Immunodiagnostics Systems Ltd

Recalled Item: IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase) Control Set

The Issue: It has been noted by staff at IDS

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

Class II — Potential Health HazardTerminated
August 10, 2012· Immunodiagnostics Systems Ltd

Recalled Item: IDS-iSYS Intact PINP Control Set

The Issue: It has been noted by staff at IDS

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

Class II — Potential Health HazardTerminated
August 10, 2012· Immunodiagnostics Systems Ltd

Recalled Item: IDS-iSYS Intact PINP

The Issue: It has been noted by staff at IDS

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

Class II — Potential Health HazardTerminated
August 10, 2012· Immunodiagnostics Systems Ltd

Recalled Item: IDS-iSYS N-Mid¿ Osteocalcin

The Issue: It has been noted by staff at IDS

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

Class II — Potential Health HazardTerminated
August 10, 2012· Immunodiagnostics Systems Ltd

Recalled Item: IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase)

The Issue: It has been noted by staff at IDS

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

Class II — Potential Health HazardTerminated
August 10, 2012· Capsule Tech Inc.

Recalled Item: Capsule Neuron Docking Station

The Issue: Capsule Neuron Docking Station may experience a lost

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

Class II — Potential Health HazardTerminated
August 10, 2012· Steris Corporation

Recalled Item: QKC1692E The QKC1692E Quick Connect device connects endoscopes to the

The Issue: STERIS has been actively seeking devices for quick

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

Class II — Potential Health HazardTerminated
August 9, 2012· Stryker Spine

Recalled Item: SPECIALTY AUDIBLE TORQUE WRENCH

The Issue: Multiple complaints have reported the hex tip of

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

Class II — Potential Health HazardTerminated
August 9, 2012· Stryker Spine

Recalled Item: Stryker MANTIS TORQUE WRENCH Manufactured by: Stryker pine

The Issue: Multiple complaints have reported the hex tip of

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

Class II — Potential Health HazardTerminated
August 9, 2012· Stryker Spine

Recalled Item: Stryker XIA 3 TORQUE WRENCH Manufactured by: Stryker

The Issue: Multiple complaints have reported the hex tip of

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

Class II — Potential Health HazardTerminated
August 9, 2012· Siemens Healthcare Diagnostics, Inc.

Recalled Item: Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent...

The Issue: Firm has received complaints from customers of "Abnormal

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

Class II — Potential Health HazardTerminated
August 9, 2012· Applied Medical Resources Corp

Recalled Item: Biliary Catheters (Models A47XX and CB0XXXXX): Model Numbers & Description:

The Issue: Applied Medical is recalling specific lot numbers of

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

Class II — Potential Health HazardTerminated