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 29821–29840 of 38,428 recalls

June 26, 2015· Hardy Diagnostics

Recalled Item: Hardy Diagnostics MacConkey Agar with CiPRP

The Issue: Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin,

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

Class II — Potential Health HazardTerminated
June 26, 2015· Hardy Diagnostics

Recalled Item: Hardy Diagnostics BEA Agar with Vancomycin container type: 15x100mm monoplate

The Issue: Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin,

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

Class II — Potential Health HazardTerminated
June 26, 2015· Hardy Diagnostics

Recalled Item: Hardy Diagnostics MDR Acinetobacter container type: 15x100mm monoplate...

The Issue: Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin,

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

Class II — Potential Health HazardTerminated
June 26, 2015· Hardy Diagnostics

Recalled Item: Hardy Diagnostics BEA Broth with Vancomycin container type: 13x100mm tube

The Issue: Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin,

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

Class II — Potential Health HazardTerminated
June 26, 2015· Alere Scarborough, Inc. dba Binax, Inc.

Recalled Item: Alere i flu

The Issue: Risk of false negative results due to microbial

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

Class II — Potential Health HazardTerminated
June 26, 2015· AGFA Healthcare Corp.

Recalled Item: IMPAX Agility. IMPAX Agility when deployed as a departmental Picture

The Issue: Firm received a complaint that the hospital had

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

Class II — Potential Health HazardTerminated
June 25, 2015· Stryker Howmedica Osteonics Corp.

Recalled Item: Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I

The Issue: it was discovered that item 623-10-36I Lot 3Y0KHP,

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

Class II — Potential Health HazardTerminated
June 25, 2015· Siemens Medical Solutions USA, Inc.

Recalled Item: ACUSON S 1000

The Issue: measurement error on ACUSON S Family ultrasound

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

Class II — Potential Health HazardTerminated
June 25, 2015· Siemens Medical Solutions USA, Inc.

Recalled Item: ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual

The Issue: measurement error on ACUSON S Family ultrasound

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

Class II — Potential Health HazardTerminated
June 25, 2015· Tornier, Inc

Recalled Item: Aequalis Humeral Nail Targeting Jig

The Issue: Recall for the Aequalis IM Nail instrumentation set

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

Class II — Potential Health HazardTerminated
June 24, 2015· Stryker Howmedica Osteonics Corp.

Recalled Item: rHead Lateral Stem

The Issue: Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion,

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

Class II — Potential Health HazardTerminated
June 24, 2015· Stryker Howmedica Osteonics Corp.

Recalled Item: uHead

The Issue: Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion,

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

Class II — Potential Health HazardTerminated
June 24, 2015· Stryker Howmedica Osteonics Corp.

Recalled Item: Radio-Capitellum

The Issue: Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion,

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

Class II — Potential Health HazardTerminated
June 24, 2015· Stryker Howmedica Osteonics Corp.

Recalled Item: Sigmoid Notch

The Issue: Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion,

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

Class II — Potential Health HazardTerminated
June 24, 2015· Stryker Howmedica Osteonics Corp.

Recalled Item: Recon

The Issue: Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion,

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

Class II — Potential Health HazardTerminated
June 24, 2015· Roche Diagnostics Operations, Inc.

Recalled Item: S2 Fluid Pack on the Cobas b 221 system- Catalog

The Issue: The affected S2 fluid packs may generate a

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

Class II — Potential Health HazardTerminated
June 24, 2015· Zimmer Surgical Inc

Recalled Item: 30inch Dual Port/Single Bladder Disposable Tourniquet Cuff with PLC

The Issue: The inside of the folded Instructions For Use

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

Class II — Potential Health HazardTerminated
June 24, 2015· Zimmer Surgical Inc

Recalled Item: 18inch Dual Port/Single Bladder Disposable Tourniquet Cuff

The Issue: The inside of the folded Instructions For Use

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

Class II — Potential Health HazardTerminated
June 24, 2015· ErgoSafe Products, LLC (DBA) Prism Medical

Recalled Item: Prism Medical P-440 Portable Ceiling Lift

The Issue: There is a potential the sling loops may

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

Class II — Potential Health HazardTerminated
June 24, 2015· Encore Medical, Lp

Recalled Item: FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block -

The Issue: The markings on the distal face of the

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

Class II — Potential Health HazardTerminated