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 17641–17660 of 38,428 recalls

May 31, 2019· Bard Peripheral Vascular Inc

Recalled Item: GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet

The Issue: The action is being initiated due to complaints

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

Class II — Potential Health HazardTerminated
May 31, 2019· Bard Peripheral Vascular Inc

Recalled Item: EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER

The Issue: The action is being initiated due to complaints

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

Class II — Potential Health HazardTerminated
May 31, 2019· Bard Peripheral Vascular Inc

Recalled Item: GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet

The Issue: The action is being initiated due to complaints

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

Class II — Potential Health HazardTerminated
May 31, 2019· Bard Peripheral Vascular Inc

Recalled Item: EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet

The Issue: The action is being initiated due to complaints

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

Class II — Potential Health HazardTerminated
May 31, 2019· Bard Peripheral Vascular Inc

Recalled Item: GlidePath Long-Term Hemodialysis Catheter

The Issue: The action is being initiated due to complaints

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

Class II — Potential Health HazardTerminated
May 31, 2019· Bard Peripheral Vascular Inc

Recalled Item: EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER

The Issue: The action is being initiated due to complaints

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

Class II — Potential Health HazardTerminated
May 31, 2019· Bard Peripheral Vascular Inc

Recalled Item: EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet

The Issue: The action is being initiated due to complaints

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

Class II — Potential Health HazardTerminated
May 31, 2019· Bard Peripheral Vascular Inc

Recalled Item: EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet

The Issue: The action is being initiated due to complaints

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

Class II — Potential Health HazardTerminated
May 31, 2019· Bard Peripheral Vascular Inc

Recalled Item: GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet

The Issue: The action is being initiated due to complaints

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

Class II — Potential Health HazardTerminated
May 31, 2019· Bard Peripheral Vascular Inc

Recalled Item: EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet

The Issue: The action is being initiated due to complaints

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

Class II — Potential Health HazardTerminated
May 31, 2019· Bard Peripheral Vascular Inc

Recalled Item: EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet

The Issue: The action is being initiated due to complaints

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

Class II — Potential Health HazardTerminated
May 31, 2019· Bard Peripheral Vascular Inc

Recalled Item: EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet

The Issue: The action is being initiated due to complaints

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

Class II — Potential Health HazardTerminated
May 31, 2019· Bard Peripheral Vascular Inc

Recalled Item: EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet

The Issue: The action is being initiated due to complaints

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

Class II — Potential Health HazardTerminated
May 31, 2019· Bard Peripheral Vascular Inc

Recalled Item: EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet

The Issue: The action is being initiated due to complaints

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

Class II — Potential Health HazardTerminated
May 31, 2019· Bard Peripheral Vascular Inc

Recalled Item: EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER

The Issue: The action is being initiated due to complaints

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

Class II — Potential Health HazardTerminated
May 31, 2019· Bard Peripheral Vascular Inc

Recalled Item: GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet

The Issue: The action is being initiated due to complaints

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

Class II — Potential Health HazardTerminated
May 31, 2019· Baxter Healthcare Corporation

Recalled Item: REVACLEAR 400 Dialyzer

The Issue: There is a potential presence of ruptured dialyzer

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

Class II — Potential Health HazardTerminated
May 31, 2019· Baxter Healthcare Corporation

Recalled Item: REVACLEAR 300 Dialyzer

The Issue: There is a potential presence of ruptured dialyzer

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

Class II — Potential Health HazardTerminated
May 31, 2019· Infinium Medical, Inc

Recalled Item: CLEO Patient Monitor /Tranquility VS Patient Monitor

The Issue: The CLEO & Tranquility VS Patient Monitors 510(k)

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

Class II — Potential Health HazardOngoing
May 30, 2019· Clinical Innovations, LLC

Recalled Item: Clearview Total Uterine Manipulator (model UM750)

The Issue: An incorrect component used during manufacturing. The uterine

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

Class II — Potential Health HazardTerminated