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 19001–19020 of 38,428 recalls

January 8, 2019· GETINGE US SALES LLC

Recalled Item: Maquet XS Flat Screen Monitor Holder

The Issue: The affected flat screen monitor holders might not

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

Class II — Potential Health HazardTerminated
January 8, 2019· GETINGE US SALES LLC

Recalled Item: Maquet XS Flat Screen Monitor Holder

The Issue: The affected flat screen monitor holders might not

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

Class II — Potential Health HazardTerminated
January 7, 2019· Acuity Surgical Devices, LLC

Recalled Item: A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A

The Issue: Due to a manufacturing process issue, it allowed

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

Class II — Potential Health HazardOngoing
January 7, 2019· Acuity Surgical Devices, LLC

Recalled Item: A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A

The Issue: Due to a manufacturing process issue, it allowed

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

Class II — Potential Health HazardOngoing
January 7, 2019· Linet Spol. S.r.o.

Recalled Item: AVE 2 Birthing Bed

The Issue: LINET has recently become aware of a potential

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

Class II — Potential Health HazardTerminated
January 7, 2019· Teleflex Medical

Recalled Item: Pilling COOLEY SUMP-SUCTION TUBE

The Issue: The internal tip is missing from the device,

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

Class II — Potential Health HazardTerminated
January 7, 2019· Smith & Nephew, Inc.

Recalled Item: SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM

The Issue: The pin that holds the spring mechanism is

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

Class II — Potential Health HazardTerminated
January 4, 2019· Remel Inc.

Recalled Item: SWIN 2017 database

The Issue: for out of range microbial results

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

Class II — Potential Health HazardTerminated
January 4, 2019· Cook Inc.

Recalled Item: Universa Firm Ureteral Stent

The Issue: The wire guide may be incorrectly loaded into

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

Class II — Potential Health HazardTerminated
January 4, 2019· Cook Inc.

Recalled Item: PTFE Wire Guide

The Issue: The wire guide may be incorrectly loaded into

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

Class II — Potential Health HazardTerminated
January 4, 2019· Cook Inc.

Recalled Item: Angled Tip Ureteral Catheter Set with Bentson PTFE Wire Guide

The Issue: The wire guide may be incorrectly loaded into

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

Class II — Potential Health HazardTerminated
January 4, 2019· Cook Inc.

Recalled Item: Bander Ureteral Diversion Open-End Stent Set

The Issue: The wire guide may be incorrectly loaded into

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

Class II — Potential Health HazardTerminated
January 4, 2019· Cook Inc.

Recalled Item: Urethral Dilation Balloon Catheter with Open Tip

The Issue: The wire guide may be incorrectly loaded into

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

Class II — Potential Health HazardTerminated
January 4, 2019· Cook Inc.

Recalled Item: C-Flex Double Pigtail Ureteral Stent Set

The Issue: The wire guide may be incorrectly loaded into

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

Class II — Potential Health HazardTerminated
January 4, 2019· Cook Inc.

Recalled Item: Percutaneous Entry Set

The Issue: The wire guide may be incorrectly loaded into

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

Class II — Potential Health HazardTerminated
January 4, 2019· Cook Inc.

Recalled Item: Sof-Flex Double Pigtail Ureteral Stent Set

The Issue: The wire guide may be incorrectly loaded into

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

Class II — Potential Health HazardTerminated
January 4, 2019· Cook Inc.

Recalled Item: Kwart Retro-Inject Ureteral Stent Set

The Issue: The wire guide may be incorrectly loaded into

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

Class II — Potential Health HazardTerminated
January 4, 2019· Cook Inc.

Recalled Item: Wire Guide

The Issue: The wire guide may be incorrectly loaded into

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

Class II — Potential Health HazardTerminated
January 4, 2019· Cook Inc.

Recalled Item: Urethral Dilator Set

The Issue: The wire guide may be incorrectly loaded into

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

Class II — Potential Health HazardTerminated
January 4, 2019· Cook Inc.

Recalled Item: Roadrunner Hydrophilic PC Wire Guide

The Issue: The wire guide may be incorrectly loaded into

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

Class II — Potential Health HazardTerminated