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 25481–25500 of 38,428 recalls

December 13, 2016· Siemens Medical Solutions USA Inc.

Recalled Item: Biograph mCT Flow 40-4R

The Issue: Siemens Medical Solutions, Molecular Imaging has become aware,

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

Class II — Potential Health HazardTerminated
December 13, 2016· Siemens Medical Solutions USA Inc.

Recalled Item: Biograph mCT S(40)-3R

The Issue: Siemens Medical Solutions, Molecular Imaging has become aware,

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

Class II — Potential Health HazardTerminated
December 13, 2016· Siemens Medical Solutions USA Inc.

Recalled Item: Biograph mCT Flow Edge-4R

The Issue: Siemens Medical Solutions, Molecular Imaging has become aware,

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

Class II — Potential Health HazardTerminated
December 12, 2016· Olympus Corporation of the Americas

Recalled Item: Uretero-reno videoscope URF-V2 and URF-V2R endoscope and accessories The...

The Issue: Olympus has received complaints regarding the breakage of

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

Class II — Potential Health HazardTerminated
December 12, 2016· Olympus Corporation of the Americas

Recalled Item: URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope

The Issue: Olympus is recalling the URF-P6/P6R endoscopes due to

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

Class II — Potential Health HazardTerminated
December 12, 2016· Implant Direct Sybron Manufacturing, LLC

Recalled Item: SwishTapered Implant

The Issue: The extender product code (9037-03) that is packaged

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

Class II — Potential Health HazardTerminated
December 12, 2016· Pentax of America Inc

Recalled Item: Rigid Laryngostroboscopes The Rigid Laryngostroboscopes

The Issue: Pentax is initiating a Field Correction to revise

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

Class II — Potential Health HazardTerminated
December 12, 2016· Great Basin Scientific, Inc.

Recalled Item: Great Basin Staph lD/R Blood Culture Panel The Great Basin

The Issue: The Great Basin Staph ID/R Panel is being

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

Class II — Potential Health HazardTerminated
December 12, 2016· Medtronic Navigation, Inc.

Recalled Item: AxIEM Touch N Go Pointer Probe. Model Number: 9735318. Placed

The Issue: Medtronic Navigation, Inc. announces a voluntary field action

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

Class II — Potential Health HazardTerminated
December 12, 2016· MEDLINE IND

Recalled Item: Medline E-Z Lubricating Jelly

The Issue: Product was not sterilized. Product was shipped to

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

Class II — Potential Health HazardTerminated
December 9, 2016· C.R. Bard, Inc.

Recalled Item: I-125 CE Marked QuickLink Cartridges

The Issue: Activity and quantity of seeds sent in shipments

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

Class II — Potential Health HazardTerminated
December 9, 2016· Smiths Medical ASD Inc.

Recalled Item: Smiths Medical CADD Blue-Striped IV Administration Set

The Issue: The label of the CADD Blue-Striped Administrative Set

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

Class II — Potential Health HazardTerminated
December 9, 2016· Merge Healthcare, Inc.

Recalled Item: Merge Eye Station. f/k/a: DFC-1024 & DFC-512 Digital Imaging System

The Issue: Merge received reports of Merge Eye Station being

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

Class II — Potential Health HazardTerminated
December 9, 2016· Philips Electronics North America Corporation

Recalled Item: Velara Generator with an old Firmware version used with the

The Issue: System may lock up

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

Class II — Potential Health HazardTerminated
December 9, 2016· Philips Electronics North America Corporation

Recalled Item: Velara Generator with an old Firmware version used with Philips

The Issue: System may lock up

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

Class II — Potential Health HazardTerminated
December 9, 2016· Bard Access Systems

Recalled Item: StatLock¿ PICC Plus Crescent Foam. Product Code: VPPCSP & VPPCSPCE.

The Issue: Bard Access Systems announces a voluntary field action

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

Class II — Potential Health HazardTerminated
December 9, 2016· Bard Access Systems

Recalled Item: StatLock¿ CV Plus w/Pigtail. Product Code: CV0220CE & CV0220. Packaged

The Issue: Bard Access Systems announces a voluntary field action

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

Class II — Potential Health HazardTerminated
December 9, 2016· Medtronic Inc., Cardiac Rhythm and Heart Failure

Recalled Item: Amplia MRI" CRT -D SureScan"

The Issue: During internal testing conducted as part of next

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

Class II — Potential Health HazardTerminated
December 9, 2016· Merge Healthcare, Inc.

Recalled Item: Merge Eye Station f/k/a: DFC-1024 & DFC-512 Digital Imaging System

The Issue: This recall has been initiated due to an

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

Class II — Potential Health HazardTerminated
December 8, 2016· Ortho-Clinical Diagnostics

Recalled Item: VITROS Chemistry Products UPRO Slides

The Issue: There is a potential for variable negatively and

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

Class II — Potential Health HazardTerminated