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 19041–19060 of 38,428 recalls

December 28, 2018· Fetzer Medical GmbH & Co. KG

Recalled Item: 12002 / Boss Instruments Ltd. Wrigley Obstetric Forceps

The Issue: The firm had a report of doctors being

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

Class II — Potential Health HazardTerminated
December 28, 2018· Fetzer Medical GmbH & Co. KG

Recalled Item: 16600 / Fetzer Surgical De Lee Obstetric Forceps

The Issue: The firm had a report of doctors being

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

Class II — Potential Health HazardTerminated
December 27, 2018· Cardinal Health 200, LLC

Recalled Item: Curity All Purpose Sponges

The Issue: Curity All Purpose Sponges were not sterilized and

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

Class II — Potential Health HazardTerminated
December 26, 2018· Boston Scientific Corporation

Recalled Item: Flexima Duodenal Bend Biliary Stent with Delivery System

The Issue: The sterile barrier may contain packaging seal defects

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

Class II — Potential Health HazardTerminated
December 26, 2018· Boston Scientific Corporation

Recalled Item: Flexima Duodenal Bend Biliary Stent with Delivery System

The Issue: The sterile barrier may contain packaging seal defects

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

Class II — Potential Health HazardTerminated
December 26, 2018· WEST PHARMA. SERVICES IL, LTD

Recalled Item: Vial2BAG Transfer Device

The Issue: Adverse events have been reported with the use

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

Class I — Serious Health HazardTerminated
December 26, 2018· Luminex Corporation

Recalled Item: Vergene Amplification Tray - 700uL

The Issue: On lot of VERIGENE(R) BC-GP Utility Kits (20-011-018)

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

Class III — Low RiskTerminated
December 26, 2018· Steris Corporation

Recalled Item: ATLAS Loading Car

The Issue: The ATLAS loading car may not remain fully

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

Class II — Potential Health HazardTerminated
December 26, 2018· WEST PHARMA. SERVICES IL, LTD

Recalled Item: Vial2BAG DC 13mm

The Issue: Adverse events have been reported with the use

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

Class I — Serious Health HazardTerminated
December 26, 2018· WEST PHARMA. SERVICES IL, LTD

Recalled Item: Vial2BAG DC 20mm: 1) & 2)

The Issue: Adverse events have been reported with the use

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

Class I — Serious Health HazardTerminated
December 26, 2018· Varian Medical Systems, Inc.

Recalled Item: Eclipse(TM) Treatment Planning System with Proton Convolution Superposition...

The Issue: There is an anomaly with the Eclipse(TM) Treatment

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

Class II — Potential Health HazardTerminated
December 21, 2018· Philips Healthcare

Recalled Item: DigitalDiagnost C50

The Issue: During recent evaluations of the Philips DigitalDiagnost C50

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

Class II — Potential Health HazardTerminated
December 21, 2018· Zimmer Biomet, Inc.

Recalled Item: Comprehensive Reverse Shoulder System Glenosphere Mini Baseplate with Taper...

The Issue: The product was potentially being packaged without a

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

Class II — Potential Health HazardTerminated
December 21, 2018· Philips Medical Systems Nederlands

Recalled Item: Achieva XR 1.5T/3.0T

The Issue: There is a potential for the ceiling speaker(s)

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

Class II — Potential Health HazardTerminated
December 21, 2018· Philips Medical Systems Nederlands

Recalled Item: SmartPath to dStream for XR and 3.0T

The Issue: There is a potential for the ceiling speaker(s)

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

Class II — Potential Health HazardTerminated
December 21, 2018· Philips Medical Systems Nederlands

Recalled Item: Intera 1.5T Achieva CV Nova

The Issue: There is a potential for the ceiling speaker(s)

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

Class II — Potential Health HazardTerminated
December 21, 2018· Philips Medical Systems Nederlands

Recalled Item: Enterprise 1.5T

The Issue: There is a potential for the ceiling speaker(s)

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

Class II — Potential Health HazardTerminated
December 21, 2018· Philips Medical Systems Nederlands

Recalled Item: SmartPath to dStream for 1.5T

The Issue: There is a potential for the ceiling speaker(s)

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

Class II — Potential Health HazardTerminated
December 21, 2018· Philips Medical Systems Nederlands

Recalled Item: Intera 1.0T Power/Pulsar

The Issue: There is a potential for the ceiling speaker(s)

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

Class II — Potential Health HazardTerminated
December 21, 2018· Philips Medical Systems Nederlands

Recalled Item: Ingenia Elition X

The Issue: There is a potential for the ceiling speaker(s)

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

Class II — Potential Health HazardTerminated