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 21841–21860 of 38,428 recalls

February 8, 2018· Bard Peripheral Vascular Inc

Recalled Item: POWERPORT ClearVUE Slim with Smooth Septum

The Issue: The Patient ID Card packaged with the POWERPORT

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

Class II — Potential Health HazardCompleted
February 8, 2018· Bard Peripheral Vascular Inc

Recalled Item: POWERPORT ClearVUE Slim with Smooth Septum

The Issue: The Patient ID Card packaged with the POWERPORT

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

Class II — Potential Health HazardCompleted
February 8, 2018· Bard Peripheral Vascular Inc

Recalled Item: POWERPORT ClearVUE Slim with Smooth Septum

The Issue: The Patient ID Card packaged with the POWERPORT

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

Class II — Potential Health HazardCompleted
February 8, 2018· Bard Peripheral Vascular Inc

Recalled Item: POWERPORT ClearVUE Slim with Smooth Septum

The Issue: The Patient ID Card packaged with the POWERPORT

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

Class II — Potential Health HazardCompleted
February 8, 2018· Bard Peripheral Vascular Inc

Recalled Item: POWERPORT ClearVUE isp Implantable Port With Smooth Septum and Attachable

The Issue: The Patient ID Card packaged with the POWERPORT

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

Class II — Potential Health HazardCompleted
February 8, 2018· Bard Peripheral Vascular Inc

Recalled Item: POWERPORT ClearVUE isp with Smooth Septum

The Issue: The Patient ID Card packaged with the POWERPORT

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

Class II — Potential Health HazardCompleted
February 8, 2018· Bard Peripheral Vascular Inc

Recalled Item: POWERPORT ClearVUE Slim with Smooth Septum

The Issue: The Patient ID Card packaged with the POWERPORT

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

Class II — Potential Health HazardCompleted
February 8, 2018· Life Technologies Corporation

Recalled Item: Oncomine Dx Target Test

The Issue: The lower concentration of the RNA panel could

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

Class II — Potential Health HazardTerminated
February 8, 2018· Philips Medical Systems (Cleveland) Inc

Recalled Item: Brilliance Big Bore (Radiology) - Model no. 728244

The Issue: Closing the Emergency Stop may disable the horizontal

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

Class II — Potential Health HazardTerminated
February 8, 2018· Tornier, Inc

Recalled Item: Fornier Phantom Fiber(TM) Sutures: Item Number Description SMB000425 4.5 MM

The Issue: Data has shown that degradation of a raw

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

Class II — Potential Health HazardTerminated
February 8, 2018· Philips Medical Systems (Cleveland) Inc

Recalled Item: Ingenuity Core - Model no. 728321

The Issue: Closing the Emergency Stop may disable the horizontal

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

Class II — Potential Health HazardTerminated
February 8, 2018· Philips Medical Systems (Cleveland) Inc

Recalled Item: Brilliance 16 Slice (Air) - Model no. 728246

The Issue: Closing the Emergency Stop may disable the horizontal

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

Class II — Potential Health HazardTerminated
February 8, 2018· Philips Medical Systems (Cleveland) Inc

Recalled Item: Ingenuity Core 128 - Model no. 728323

The Issue: Closing the Emergency Stop may disable the horizontal

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

Class II — Potential Health HazardTerminated
February 8, 2018· Philips Medical Systems (Cleveland) Inc

Recalled Item: Ingenuity Flex - Model no. 728317

The Issue: Closing the Emergency Stop may disable the horizontal

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

Class II — Potential Health HazardTerminated
February 8, 2018· Philips Medical Systems (Cleveland) Inc

Recalled Item: Ingenuity CT - Model no. 728326

The Issue: Closing the Emergency Stop may disable the horizontal

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

Class II — Potential Health HazardTerminated
February 8, 2018· Philips Medical Systems (Cleveland) Inc

Recalled Item: Brilliance 64 - Model no. 728231

The Issue: Closing the Emergency Stop may disable the horizontal

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

Class II — Potential Health HazardTerminated
February 8, 2018· Philips Medical Systems (Cleveland) Inc

Recalled Item: IQon Spectral CT - Model no. 728332

The Issue: Closing the Emergency Stop may disable the horizontal

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

Class II — Potential Health HazardTerminated
February 8, 2018· Philips Medical Systems (Cleveland) Inc

Recalled Item: Brilliance iCT - Model no. 728306 Computed Tomography X-Ray system

The Issue: Closing the Emergency Stop may disable the horizontal

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

Class II — Potential Health HazardTerminated
February 8, 2018· Philips Medical Systems (Cleveland) Inc

Recalled Item: Brilliance 6 Slice (Air) - Model no. 728256

The Issue: Closing the Emergency Stop may disable the horizontal

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

Class II — Potential Health HazardTerminated
February 8, 2018· Philips Medical Systems (Cleveland) Inc

Recalled Item: Brilliance iCT SP - Model no. 728311 Computed Tomography X-Ray

The Issue: Closing the Emergency Stop may disable the horizontal

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

Class II — Potential Health HazardTerminated