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 21901–21920 of 38,428 recalls

February 1, 2018· Siemens Medical Solutions USA, Inc

Recalled Item: SOMATOM Spirit(Model 10045692 )

The Issue: A potential risk of unnecessary radiation exposure due

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

Class II — Potential Health HazardTerminated
February 1, 2018· Siemens Medical Solutions USA, Inc

Recalled Item: SOMATOM Scope ( Model 10967666)

The Issue: A potential risk of unnecessary radiation exposure due

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

Class II — Potential Health HazardTerminated
February 1, 2018· Siemens Medical Solutions USA, Inc

Recalled Item: SOMATOM Emotion 6 (Model 10165888)

The Issue: A potential risk of unnecessary radiation exposure due

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

Class II — Potential Health HazardTerminated
February 1, 2018· Siemens Medical Solutions USA, Inc

Recalled Item: SOMATOM Perspective 16 (Model 10891666)

The Issue: A potential risk of unnecessary radiation exposure due

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

Class II — Potential Health HazardTerminated
February 1, 2018· Siemens Medical Solutions USA, Inc

Recalled Item: SOMATOM Perspective (Model 10495568)

The Issue: A potential risk of unnecessary radiation exposure due

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

Class II — Potential Health HazardTerminated
February 1, 2018· Siemens Medical Solutions USA, Inc

Recalled Item: SOMATOM Scope Power (Model 10967888)

The Issue: A potential risk of unnecessary radiation exposure due

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

Class II — Potential Health HazardTerminated
February 1, 2018· Siemens Medical Solutions USA, Inc

Recalled Item: SOMATOM Emotion 16 (10165977)

The Issue: A potential risk of unnecessary radiation exposure due

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

Class II — Potential Health HazardTerminated
February 1, 2018· Smith & Nephew, Inc.

Recalled Item: smith&nephew

The Issue: The screws package with devices within lot 14AAP6352A

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

Class II — Potential Health HazardTerminated
January 31, 2018· Cook Inc.

Recalled Item: StoneBreaker Exhaust Cap

The Issue: The interior of the product may not be

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

Class II — Potential Health HazardTerminated
January 31, 2018· Cook Inc.

Recalled Item: StoneBreaker Single Use Probe

The Issue: The interior of the product may not be

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

Class II — Potential Health HazardTerminated
January 31, 2018· Cook Inc.

Recalled Item: StoneBreaker Sterilization Cap

The Issue: The interior of the product may not be

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

Class II — Potential Health HazardTerminated
January 31, 2018· Cook Inc.

Recalled Item: StoneBreaker Pneumatic Lithotripter

The Issue: The interior of the product may not be

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

Class II — Potential Health HazardTerminated
January 31, 2018· Cook Inc.

Recalled Item: StoneBreaker C02 Cartridge

The Issue: The interior of the product may not be

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

Class II — Potential Health HazardTerminated
January 31, 2018· Cook Inc.

Recalled Item: StoneBreaker Probe Cap

The Issue: The interior of the product may not be

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

Class II — Potential Health HazardTerminated
January 31, 2018· Cook Inc.

Recalled Item: StoneBreaker Exhaust Line

The Issue: The interior of the product may not be

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

Class II — Potential Health HazardTerminated
January 31, 2018· 3M Company - Health Care Business

Recalled Item: ACE (TM) BRAND

The Issue: 3M discovered that the Futuro" Quick Strap Ankle

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

Class II — Potential Health HazardTerminated
January 31, 2018· 3M Company - Health Care Business

Recalled Item: FUTURO (TM) SPORT

The Issue: 3M discovered that the Futuro" Quick Strap Ankle

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

Class II — Potential Health HazardTerminated
January 30, 2018· Orthofix Srl

Recalled Item: TL-HEX TruLok Hexapod System

The Issue: The firm received complaints regarding the incompatibility and

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

Class II — Potential Health HazardTerminated
January 30, 2018· Siemens Healthcare Diagnostics, Inc.

Recalled Item: Dimension Vista¿ Calcium Flex¿ reagent cartridge

The Issue: May produce erroneously low results from specific well

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

Class II — Potential Health HazardTerminated
January 30, 2018· Howmedica Osteonics Corp.

Recalled Item: Triathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601 The knee

The Issue: Customers may receive the incorrect size implant from

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

Class II — Potential Health HazardTerminated