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 21821–21840 of 38,428 recalls

February 12, 2018· Boston Scientific Corporation

Recalled Item: Capio Open Access Box 4 (Capio OPC)

The Issue: for Capio sutures to break and /or

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

Class II — Potential Health HazardTerminated
February 12, 2018· Boston Scientific Corporation

Recalled Item: Capio CL

The Issue: for Capio sutures to break and /or

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

Class II — Potential Health HazardTerminated
February 12, 2018· Boston Scientific Corporation

Recalled Item: PFR Kit- Pinnacle

The Issue: for Capio sutures to break and /or

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

Class II — Potential Health HazardTerminated
February 12, 2018· Boston Scientific Corporation

Recalled Item: Uphold Vaginal Support System

The Issue: for Capio sutures to break and /or

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

Class II — Potential Health HazardTerminated
February 12, 2018· Boston Scientific Corporation

Recalled Item: Uphold LITE w/ Capio SLIM

The Issue: for Capio sutures to break and /or

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

Class II — Potential Health HazardTerminated
February 12, 2018· Boston Scientific Corporation

Recalled Item: Posterior LITE w/ Capio SLIM

The Issue: for Capio sutures to break and /or

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

Class II — Potential Health HazardTerminated
February 12, 2018· Boston Scientific Corporation

Recalled Item: Capio Standard Box 4 (Capio PC)

The Issue: for Capio sutures to break and /or

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

Class II — Potential Health HazardTerminated
February 12, 2018· Boston Scientific Corporation

Recalled Item: Capio SLIM Suture Capturing Device

The Issue: for Capio sutures to break and /or

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

Class II — Potential Health HazardTerminated
February 12, 2018· Boston Scientific Corporation

Recalled Item: Capio RP

The Issue: for Capio sutures to break and /or

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

Class II — Potential Health HazardTerminated
February 12, 2018· Mesa Laboratories Bozeman Manufacturing Facility

Recalled Item: SporAmpule Biological Indicator Catalog Number SPS5-100

The Issue: The concentration of bromocresol purple in the recalled

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

Class II — Potential Health HazardTerminated
February 12, 2018· Mesa Laboratories Bozeman Manufacturing Facility

Recalled Item: ProSpore Biological Indicator Part Numbers: PS-6-50

The Issue: The concentration of bromocresol purple in the recalled

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

Class II — Potential Health HazardTerminated
February 8, 2018· Stanbio Laboratory, LP

Recalled Item: Stanbio AC power adapter for the HemoPoint H2 meter

The Issue: The US prong (type A) adapter plate may

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

Class II — Potential Health HazardTerminated
February 8, 2018· Bovie Medical Corporation

Recalled Item: J-Plasma Precise(R) FLEX

The Issue: Bovie Medical is issuing a correction to address

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

Class II — Potential Health HazardTerminated
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· 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(R) ClearVUE(R) 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 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