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 30021–30040 of 38,428 recalls

May 28, 2015· American Medical Systems Innovation Center - Silicon Valley

Recalled Item: Stripper

The Issue: validation data related to cleaning instructions and sterilization

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

Class II — Potential Health HazardTerminated
May 28, 2015· American Medical Systems Innovation Center - Silicon Valley

Recalled Item: Fiber Stripper

The Issue: validation data related to cleaning instructions and sterilization

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

Class II — Potential Health HazardTerminated
May 28, 2015· American Medical Systems Innovation Center - Silicon Valley

Recalled Item: Tool

The Issue: validation data related to cleaning instructions and sterilization

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

Class II — Potential Health HazardTerminated
May 28, 2015· American Medical Systems Innovation Center - Silicon Valley

Recalled Item: Fiber Stripper

The Issue: validation data related to cleaning instructions and sterilization

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

Class II — Potential Health HazardTerminated
May 28, 2015· American Medical Systems Innovation Center - Silicon Valley

Recalled Item: Tool

The Issue: validation data related to cleaning instructions and sterilization

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

Class II — Potential Health HazardTerminated
May 28, 2015· American Medical Systems Innovation Center - Silicon Valley

Recalled Item: Fiber Stripper

The Issue: validation data related to cleaning instructions and sterilization

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

Class II — Potential Health HazardTerminated
May 28, 2015· American Medical Systems Innovation Center - Silicon Valley

Recalled Item: Sureflex 200 Lithotripsy Fiber

The Issue: validation data related to cleaning instructions and sterilization

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

Class II — Potential Health HazardTerminated
May 28, 2015· American Medical Systems Innovation Center - Silicon Valley

Recalled Item: Sureflex 365 Lithotripsy Fiber

The Issue: validation data related to cleaning instructions and sterilization

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

Class II — Potential Health HazardTerminated
May 28, 2015· American Medical Systems Innovation Center - Silicon Valley

Recalled Item: Sureflex 150 Lithotripsy Fiber

The Issue: validation data related to cleaning instructions and sterilization

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

Class II — Potential Health HazardTerminated
May 28, 2015· American Medical Systems Innovation Center - Silicon Valley

Recalled Item: Stripper

The Issue: validation data related to cleaning instructions and sterilization

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

Class II — Potential Health HazardTerminated
May 28, 2015· Synthes, Inc.

Recalled Item: Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts

The Issue: It was reported that the RIA Drive Shaft,

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

Class II — Potential Health HazardTerminated
May 28, 2015· Synthes, Inc.

Recalled Item: Pull Reduction Device For 4.3mm Percutaneous Drill Guide

The Issue: Certain affected parts and lots of the Pull

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

Class II — Potential Health HazardTerminated
May 27, 2015· Terumo Cardiovascular Systems Corporation

Recalled Item: The Sarns Centrifugal Pump is a single use device sterilized

The Issue: Terumo Cardiovascular Systems Corporation has received complaints indicating

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

Class II — Potential Health HazardTerminated
May 27, 2015· PTW-Freiburg

Recalled Item: PTW UNIDOS webline: 1)

The Issue: In some cases, especially with high dose-per-pulse-rates typical

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

Class II — Potential Health HazardTerminated
May 27, 2015· RAYSEARCH LABORATORIES AB

Recalled Item: RayStation 4.7

The Issue: Issue with the algorithm for ROI contraction in

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

Class II — Potential Health HazardTerminated
May 27, 2015· Musculoskeletal Transplant Foundation, Inc.

Recalled Item: Cortical Pin 2.0 mm

The Issue: Musculoskeletal Transplant Foundation (MTF) is recalling one lot

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

Class II — Potential Health HazardTerminated
May 27, 2015· Musculoskeletal Transplant Foundation, Inc.

Recalled Item: Allofix Insertion Kit

The Issue: Musculoskeletal Transplant Foundation is recalling a certain lot

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

Class II — Potential Health HazardTerminated
May 27, 2015· Bard Access Systems

Recalled Item: PowerPICC SOLO Catheter with Tip Location System (TLS) Stylet 4F

The Issue: Bard Access Systems is recalling PowerPICC Solo Catheter

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

Class III — Low RiskTerminated
May 27, 2015· Bard Access Systems

Recalled Item: PowerPICC SOLO Catheter with Sherlock 3CG (TPS) Stylet 5F Maximal

The Issue: Bard Access Systems is recalling PowerPICC Solo Catheter

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

Class III — Low RiskTerminated
May 27, 2015· Bard Access Systems

Recalled Item: PowerPICC SOLO2 Catheter 4F Maximal Barrier Tray with Microintroducer...

The Issue: Bard Access Systems is recalling PowerPICC Solo Catheter

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

Class III — Low RiskTerminated