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 32641–32660 of 38,428 recalls

July 11, 2014· Ortho Development Corporation

Recalled Item: Tibila Insert CK

The Issue: Ortho Development is recalling various Pivot Bipolar Cup,

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

Class II — Potential Health HazardTerminated
July 11, 2014· Ortho Development Corporation

Recalled Item: Pivot Bipolar Cup 22x42/43-51/53mm

The Issue: Ortho Development is recalling various Pivot Bipolar Cup,

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

Class II — Potential Health HazardTerminated
July 11, 2014· Ortho Development Corporation

Recalled Item: Patella 38mm

The Issue: Ortho Development is recalling various Pivot Bipolar Cup,

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

Class II — Potential Health HazardTerminated
July 11, 2014· Beevers Manufacturing & Supply, Inc.

Recalled Item: Luma Wrap Phototherapy Swaddler is designed to provide centered and

The Issue: Beevers Manufacturing & Supply Inc. is recalling Luma

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

Class II — Potential Health HazardTerminated
July 11, 2014· Medtronic Neuromodulation

Recalled Item: Medtronic Ascenda Intrathecal Catheter models 8780 and 8781

The Issue: Medtronic is removing specific lots of the Ascenda

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

Class II — Potential Health HazardTerminated
July 11, 2014· X Spine Systems Inc

Recalled Item: Serrated Soft Tissue Shields. Orthopedic surgical instruments

The Issue: Revision B of the tissue shields of the

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

Class II — Potential Health HazardTerminated
July 11, 2014· Baxter Healthcare Corporation

Recalled Item: FlowCOUPLER. An implantable device that is used to detect blood

The Issue: Baxter Healthcare is recalling the FlowCOUPLER Device because

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

Class II — Potential Health HazardTerminated
July 10, 2014· Zimmer, Inc.

Recalled Item: Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part...

The Issue: Zimmer received a trend of complaints indicating corrosion

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

Class II — Potential Health HazardTerminated
July 10, 2014· Zimmer, Inc.

Recalled Item: Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part...

The Issue: Zimmer received a trend of complaints indicating corrosion

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

Class II — Potential Health HazardTerminated
July 10, 2014· Zimmer, Inc.

Recalled Item: Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part...

The Issue: Zimmer received a trend of complaints indicating corrosion

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

Class II — Potential Health HazardTerminated
July 10, 2014· Zimmer, Inc.

Recalled Item: Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part...

The Issue: Zimmer received a trend of complaints indicating corrosion

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

Class II — Potential Health HazardTerminated
July 10, 2014· Medical Positioning Inc

Recalled Item: Medical Positioning Rapid Response HUT table

The Issue: Excessive weight on the table will cause tables

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

Class II — Potential Health HazardTerminated
July 10, 2014· Medical Positioning Inc

Recalled Item: Medical Positioning Rapid Response HUT table

The Issue: Excessive weight on the table will cause tables

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

Class II — Potential Health HazardTerminated
July 10, 2014· Medical Positioning Inc

Recalled Item: Medical Positioning Rapid Response HUT table with Dual 2 Way Drop Section

The Issue: Excessive weight on the table will cause tables

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

Class II — Potential Health HazardTerminated
July 10, 2014· Medical Positioning Inc

Recalled Item: Medical Positioning Rapid Response HUT table

The Issue: Excessive weight on the table will cause tables

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

Class II — Potential Health HazardTerminated
July 10, 2014· Teleflex Medical

Recalled Item: RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe

The Issue: Labeling error: The manufacturing date is the same

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

Class III — Low RiskTerminated
July 9, 2014· Richard Wolf Medical Instruments Corp.

Recalled Item: The Hulka Clip is a sterile packaged medical device that

The Issue: Richard Wolf Medical Instrument Corporation is recalling Hulka

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

Class II — Potential Health HazardTerminated
July 9, 2014· Nanosphere, Inc.

Recalled Item: Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20

The Issue: Nanosphere Inc. has recently determined through four customer

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

Class II — Potential Health HazardTerminated
July 9, 2014· Carestream Health, Inc.

Recalled Item: Kodak DirectView DR 7500 Diagnostic X-Ray System Product Usage: The

The Issue: An on-site evaluation of the equipment parts that

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

Class II — Potential Health HazardTerminated
July 9, 2014· Teleflex Medical

Recalled Item: Emerald Fiberoptic Blade

The Issue: Packaging Error: Customers have reported receiving incorrect product

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

Class II — Potential Health HazardTerminated