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 15321–15340 of 38,428 recalls

April 7, 2020· Maquet Cardiovascular, LLC

Recalled Item: HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch

The Issue: small holes at the seam lines of

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

Class II — Potential Health HazardTerminated
April 7, 2020· Maquet Cardiovascular, LLC

Recalled Item: HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch

The Issue: small holes at the seam lines of

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

Class II — Potential Health HazardTerminated
April 7, 2020· Maquet Cardiovascular, LLC

Recalled Item: HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch

The Issue: small holes at the seam lines of

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

Class II — Potential Health HazardTerminated
April 7, 2020· Maquet Cardiovascular, LLC

Recalled Item: Hemashield Gold Knitted Microvel Double Velour Vascular Graft Axillo-bifemoral

The Issue: small holes at the seam lines of

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

Class II — Potential Health HazardTerminated
April 7, 2020· Maquet Cardiovascular, LLC

Recalled Item: HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch

The Issue: small holes at the seam lines of

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

Class II — Potential Health HazardTerminated
April 7, 2020· Maquet Cardiovascular, LLC

Recalled Item: HEMASHIELD PLATINUM Woven Double Velour Vascular Graft01 Branch

The Issue: small holes at the seam lines of

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

Class II — Potential Health HazardTerminated
April 7, 2020· Maquet Cardiovascular, LLC

Recalled Item: HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch

The Issue: small holes at the seam lines of

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

Class II — Potential Health HazardTerminated
April 7, 2020· Maquet Cardiovascular, LLC

Recalled Item: HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch

The Issue: small holes at the seam lines of

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

Class II — Potential Health HazardTerminated
April 7, 2020· Inpeco S.A.

Recalled Item: Siemens Aptio Automation Centrifuge Module

The Issue: The FlexLab Centrifuge Module loading algorithm may lead

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

Class II — Potential Health HazardOngoing
April 7, 2020· Maquet Cardiovascular, LLC

Recalled Item: HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch

The Issue: small holes at the seam lines of

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

Class II — Potential Health HazardTerminated
April 7, 2020· Maquet Cardiovascular, LLC

Recalled Item: HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Thoracoabdominal

The Issue: small holes at the seam lines of

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

Class II — Potential Health HazardTerminated
April 7, 2020· Maquet Cardiovascular, LLC

Recalled Item: HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch

The Issue: small holes at the seam lines of

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

Class II — Potential Health HazardTerminated
April 7, 2020· Maquet Cardiovascular, LLC

Recalled Item: HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch

The Issue: small holes at the seam lines of

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

Class II — Potential Health HazardTerminated
April 7, 2020· Maquet Cardiovascular, LLC

Recalled Item: HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch

The Issue: small holes at the seam lines of

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

Class II — Potential Health HazardTerminated
April 7, 2020· Maquet Cardiovascular, LLC

Recalled Item: HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch

The Issue: small holes at the seam lines of

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

Class II — Potential Health HazardTerminated
April 7, 2020· Maquet Cardiovascular, LLC

Recalled Item: Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemoral

The Issue: small holes at the seam lines of

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

Class II — Potential Health HazardTerminated
April 7, 2020· Maquet Cardiovascular, LLC

Recalled Item: HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Thoracoabdominal

The Issue: small holes at the seam lines of

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

Class II — Potential Health HazardTerminated
April 7, 2020· Maquet Cardiovascular, LLC

Recalled Item: HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch

The Issue: small holes at the seam lines of

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

Class II — Potential Health HazardTerminated
April 7, 2020· Maquet Cardiovascular, LLC

Recalled Item: HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch

The Issue: small holes at the seam lines of

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

Class II — Potential Health HazardTerminated
April 7, 2020· Maquet Cardiovascular, LLC

Recalled Item: HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch

The Issue: small holes at the seam lines of

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

Class II — Potential Health HazardTerminated