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 26821–26840 of 38,428 recalls

June 24, 2016· Moller Vital

Recalled Item: Molift Air 205

The Issue: for the bolt on the suspension coupling

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

Class II — Potential Health HazardTerminated
June 24, 2016· Stryker Instruments Div. of Stryker Corporation

Recalled Item: 2.3MM Tapered Router

The Issue: A variation in flute depth on the routers

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

Class II — Potential Health HazardTerminated
June 24, 2016· Becton, Dickinson and Company, BD Biosciences

Recalled Item: BD Trucount Tubes: Catalog number: 340334 Hematology: BD Trucount tubes

The Issue: One lot of BD Trucount Absolute Counting Tubes

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

Class II — Potential Health HazardTerminated
June 23, 2016· Philips Medical Systems Nederlands

Recalled Item: Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product...

The Issue: Certain low-voltage DC power supplies (DCPS) used in

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

Class II — Potential Health HazardTerminated
June 23, 2016· Olympus Corporation of the Americas

Recalled Item: OER-Pro Endoscope Reprocessor

The Issue: New warning requiring Users to conduct duodenoscope precleaning

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

Class II — Potential Health HazardTerminated
June 23, 2016· Medtronic Neuromodulation

Recalled Item: DBS Pocket Adaptor

The Issue: Due to the potential for pocket adaptor conductor

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

Class II — Potential Health HazardTerminated
June 23, 2016· The Metrix Company

Recalled Item: AUTOCOMP6 High Speed Compounder

The Issue: An issue was identified after a redesign of

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

Class II — Potential Health HazardTerminated
June 23, 2016· Mindray DS USA, Inc. dba Mindray North America

Recalled Item: Mindray DS USA Inc.

The Issue: Mindray has identified a potential leakage issue with

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

Class II — Potential Health HazardTerminated
June 23, 2016· Stryker Howmedica Osteonics Corp.

Recalled Item: Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with...

The Issue: It was reported that the secondary locking mechanism,

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

Class II — Potential Health HazardTerminated
June 23, 2016· Stryker Howmedica Osteonics Corp.

Recalled Item: Stryker Orthopaedics Modular Handle Triathlon Instruments

The Issue: Stryker Orthopaedic is voluntarily recalling the Triathlon Modular

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

Class II — Potential Health HazardTerminated
June 23, 2016· Edan Diagnostics

Recalled Item: EtCO2 Module -Part Number: 02.01.210699 Monitors: iM80

The Issue: Incorrect CO2 readings with some patient monitors

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

Class II — Potential Health HazardTerminated
June 23, 2016· The Metrix Company

Recalled Item: AUTOCOMP6 XPS High Speed Compounder

The Issue: An issue was identified after a redesign of

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

Class II — Potential Health HazardTerminated
June 23, 2016· The Metrix Company

Recalled Item: AUTOCOMP6 XP High Speed Compounder

The Issue: An issue was identified after a redesign of

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

Class II — Potential Health HazardTerminated
June 23, 2016· The Metrix Company

Recalled Item: Container fill and transfer sets

The Issue: An issue was identified after a redesign of

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

Class II — Potential Health HazardTerminated
June 23, 2016· The Metrix Company

Recalled Item: Container fill and transfer sets

The Issue: An issue was identified after a redesign of

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

Class II — Potential Health HazardTerminated
June 23, 2016· The Metrix Company

Recalled Item: Dual Chamber Container fill with gravity/attached transfer sets

The Issue: An issue was identified after a redesign of

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

Class II — Potential Health HazardTerminated
June 23, 2016· The Metrix Company

Recalled Item: Container fill and transfer sets

The Issue: An issue was identified after a redesign of

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

Class II — Potential Health HazardTerminated
June 23, 2016· The Metrix Company

Recalled Item: Dual Chamber Container fill and transfer sets

The Issue: An issue was identified after a redesign of

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

Class II — Potential Health HazardTerminated
June 23, 2016· Siemens Medical Solutions USA, Inc

Recalled Item: Syngo.via

The Issue: Incorrect values for the volume calculation. Software update

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

Class II — Potential Health HazardTerminated
June 23, 2016· Varian Medical Systems, Inc.

Recalled Item: Optical Surface Monitoring System{OSMS

The Issue: Varian Medical Systems has received reports that unintended

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

Class II — Potential Health HazardTerminated