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 26861–26880 of 38,428 recalls

June 22, 2016· Nobel Biocare Usa Llc

Recalled Item: Replace Select Tapered TiU NP 3.5x11.5mm

The Issue: Incorrect top label on an implant package

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

Class II — Potential Health HazardTerminated
June 22, 2016· Sorin Group USA, Inc.

Recalled Item: AORTIC ARCH CANNULA

The Issue: Sorin Group USA is recalling Aortic Arch Cannulae

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

Class II — Potential Health HazardTerminated
June 21, 2016· MicroPort Orthopedics Inc.

Recalled Item: Dynasty Liners:

The Issue: Revision rate trends from within the MicroPort Orthopedics

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

Class III — Low RiskTerminated
June 21, 2016· MicroPort Orthopedics Inc.

Recalled Item: Cobalt Chromium Heads Transcend: 26000017

The Issue: Revision rate trends from within the MicroPort Orthopedics

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

Class III — Low RiskTerminated
June 21, 2016· MicroPort Orthopedics Inc.

Recalled Item: Procotyl (Rim- Lock) Liners:

The Issue: Revision rate trends from within the MicroPort Orthopedics

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

Class III — Low RiskTerminated
June 21, 2016· MicroPort Orthopedics Inc.

Recalled Item: Conserve Cups:

The Issue: Revision rate trends from within the MicroPort Orthopedics

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

Class III — Low RiskTerminated
June 21, 2016· MicroPort Orthopedics Inc.

Recalled Item: Conserve Shells:

The Issue: Revision rate trends from within the MicroPort Orthopedics

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

Class III — Low RiskTerminated
June 21, 2016· MicroPort Orthopedics Inc.

Recalled Item: Lineage Shell:

The Issue: Revision rate trends from within the MicroPort Orthopedics

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

Class III — Low RiskTerminated
June 21, 2016· MicroPort Orthopedics Inc.

Recalled Item: Lineage Liners:

The Issue: Revision rate trends from within the MicroPort Orthopedics

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

Class III — Low RiskTerminated
June 21, 2016· MicroPort Orthopedics Inc.

Recalled Item: ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES

The Issue: ADVANCE(R) HA Coated tibial bases are being recalled

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

Class I — Serious Health HazardTerminated
June 21, 2016· MicroPort Orthopedics Inc.

Recalled Item: ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES

The Issue: ADVANCE(R) HA Coated tibial bases are being recalled

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

Class I — Serious Health HazardTerminated
June 21, 2016· MicroPort Orthopedics Inc.

Recalled Item: ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES

The Issue: ADVANCE(R) HA Coated tibial bases are being recalled

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

Class I — Serious Health HazardTerminated
June 21, 2016· MicroPort Orthopedics Inc.

Recalled Item: ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES

The Issue: ADVANCE(R) HA Coated tibial bases are being recalled

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

Class I — Serious Health HazardTerminated
June 21, 2016· MicroPort Orthopedics Inc.

Recalled Item: ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES

The Issue: ADVANCE(R) HA Coated tibial bases are being recalled

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

Class I — Serious Health HazardTerminated
June 21, 2016· MicroPort Orthopedics Inc.

Recalled Item: ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES

The Issue: ADVANCE(R) HA Coated tibial bases are being recalled

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

Class I — Serious Health HazardTerminated
June 21, 2016· Omega Medical Imaging, Inc.

Recalled Item: 2 over 2 Elevating Monitor Suspension - Omega Medical Imaging

The Issue: Elevating Monitor Suspension separated from the lifting column

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

Class II — Potential Health HazardTerminated
June 21, 2016· MicroPort Orthopedics Inc.

Recalled Item: ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES

The Issue: ADVANCE(R) HA Coated tibial bases are being recalled

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

Class I — Serious Health HazardTerminated
June 21, 2016· MicroPort Orthopedics Inc.

Recalled Item: ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES

The Issue: ADVANCE(R) HA Coated tibial bases are being recalled

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

Class I — Serious Health HazardTerminated
June 21, 2016· MicroPort Orthopedics Inc.

Recalled Item: ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES

The Issue: ADVANCE(R) HA Coated tibial bases are being recalled

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

Class I — Serious Health HazardTerminated
June 21, 2016· MicroPort Orthopedics Inc.

Recalled Item: ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES

The Issue: ADVANCE(R) HA Coated tibial bases are being recalled

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

Class I — Serious Health HazardTerminated