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 36021–36040 of 38,428 recalls

March 25, 2013· Microbiologics Inc

Recalled Item: KWIK-STIK(TM)

The Issue: Some of the KWIK-STIK Catalog #01023P Campylobacter coli,

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

Class III — Low RiskTerminated
March 25, 2013· Remel Inc

Recalled Item: Oxoid Antimicrobial Susceptibility Test Discs F300 (Nitrofurantoin)

The Issue: Use of affected lots may give false indication

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

Class III — Low RiskTerminated
March 25, 2013· Stryker Howmedica Osteonics Corp.

Recalled Item: Stryker Orthopaedics Triathlon Femoral Distal Augment- Left

The Issue: Stryker Orthopaedics received a report that a label

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

Class II — Potential Health HazardTerminated
March 22, 2013· DePuy Mitek, Inc., a Johnson & Johnson Co.

Recalled Item: ORTHOCORD One Violet and One Blue Braided Composite Suture with

The Issue: The IFU provided with the free strand ORTHOCORD

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

Class II — Potential Health HazardTerminated
March 22, 2013· DePuy Mitek, Inc., a Johnson & Johnson Co.

Recalled Item: ORTHOCORD BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC)

The Issue: The IFU provided with the free strand ORTHOCORD

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

Class II — Potential Health HazardTerminated
March 22, 2013· DePuy Mitek, Inc., a Johnson & Johnson Co.

Recalled Item: ORTHOCORD One Violet and One Blue Braided Composite Suture with

The Issue: The IFU provided with the free strand ORTHOCORD

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

Class II — Potential Health HazardTerminated
March 22, 2013· DePuy Mitek, Inc., a Johnson & Johnson Co.

Recalled Item: ORTHOCORD ONE VIOLET AND ONE BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC)

The Issue: The IFU provided with the free strand ORTHOCORD

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

Class II — Potential Health HazardTerminated
March 22, 2013· DePuy Mitek, Inc., a Johnson & Johnson Co.

Recalled Item: ORTHOCORD One Violet and One Blue Braided Composite Suture with

The Issue: The IFU provided with the free strand ORTHOCORD

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

Class II — Potential Health HazardTerminated
March 22, 2013· Advanced Sterilization Products

Recalled Item: EVOTECH Endoscope Cleaner & Reprocessor System

The Issue: Advanced Sterilization Products (ASP) has determined that a

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

Class II — Potential Health HazardTerminated
March 22, 2013· Lighthouse For The Blind

Recalled Item: LHB

The Issue: The product contains an iodine 10% Ampule (10%

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

Class III — Low RiskTerminated
March 22, 2013· Medtronic MiniMed

Recalled Item: Medtronic MiniMed Paradigm Insulin Infusion Pumps Model Numbers: MMT-511

The Issue: Medtronic is recalling the Medtronic Paradigm Insulin Pump

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

Class II — Potential Health HazardTerminated
March 22, 2013· Lighthouse For The Blind

Recalled Item: LHB

The Issue: The product contains an iodine 10% Ampule (10%

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

Class III — Low RiskTerminated
March 22, 2013· Lighthouse For The Blind

Recalled Item: LHB

The Issue: The product contains an iodine 10% Ampule (10%

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

Class III — Low RiskTerminated
March 22, 2013· Lighthouse For The Blind

Recalled Item: LHB

The Issue: The product contains an iodine 10% Ampule (10%

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

Class III — Low RiskTerminated
March 22, 2013· Advanced Sterilization Products

Recalled Item: STERRAD 100NX Sterilization System

The Issue: The recall was initiated because Advanced Sterilization Products

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

Class II — Potential Health HazardTerminated
March 22, 2013· Lighthouse For The Blind

Recalled Item: LHB

The Issue: The product contains an iodine 10% Ampule (10%

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

Class III — Low RiskTerminated
March 22, 2013· Lighthouse For The Blind

Recalled Item: LHB

The Issue: The product contains an iodine 10% Ampule (10%

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

Class III — Low RiskTerminated
March 22, 2013· Lighthouse For The Blind

Recalled Item: LHB

The Issue: The product contains an iodine 10% Ampule (10%

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

Class III — Low RiskTerminated
March 22, 2013· Lighthouse For The Blind

Recalled Item: LHB

The Issue: The product contains an iodine 10% Ampule (10%

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

Class III — Low RiskTerminated
March 22, 2013· Advanced Sterilization Products

Recalled Item: STERRAD 200 Sterilization System

The Issue: The recall was initiated because Advanced Sterilization Products

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

Class II — Potential Health HazardTerminated