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 22841–22860 of 38,428 recalls

September 19, 2017· Exactech, Inc.

Recalled Item: Optetrak Constrained Condylar Offset Screw

The Issue: There is a design incompatibility between certain sizes

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

Class II — Potential Health HazardTerminated
September 19, 2017· Exactech, Inc.

Recalled Item: Optetrak Offset Tibial Tray and Screws

The Issue: There is a design incompatibility between certain sizes

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

Class II — Potential Health HazardTerminated
September 19, 2017· Exactech, Inc.

Recalled Item: Optetrak Offset Tibial Tray and Screws

The Issue: There is a design incompatibility between certain sizes

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

Class II — Potential Health HazardTerminated
September 19, 2017· Exactech, Inc.

Recalled Item: Optetrak Constrained Condylar Offset Screw

The Issue: There is a design incompatibility between certain sizes

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

Class II — Potential Health HazardTerminated
September 19, 2017· Exactech, Inc.

Recalled Item: Optetrak Offset Tibial Tray and Screws

The Issue: There is a design incompatibility between certain sizes

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

Class II — Potential Health HazardTerminated
September 19, 2017· Exactech, Inc.

Recalled Item: Optetrak Offset Tibial Tray and Screws

The Issue: There is a design incompatibility between certain sizes

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

Class II — Potential Health HazardTerminated
September 19, 2017· Exactech, Inc.

Recalled Item: Optetrak Offset Tibial Tray and Screws

The Issue: There is a design incompatibility between certain sizes

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

Class II — Potential Health HazardTerminated
September 19, 2017· Exactech, Inc.

Recalled Item: Optetrak Offset Tibial Tray and Screws

The Issue: There is a design incompatibility between certain sizes

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

Class II — Potential Health HazardTerminated
September 19, 2017· Exactech, Inc.

Recalled Item: Optetrak Offset Tibial Tray and Screws

The Issue: There is a design incompatibility between certain sizes

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

Class II — Potential Health HazardTerminated
September 18, 2017· Becton Dickinson & Company

Recalled Item: BD Vacutainer¿ Barricor" Lithium Heparin Plasma Blood Collection Tubes for

The Issue: Increased amount of residual blood present on the

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

Class II — Potential Health HazardTerminated
September 18, 2017· Siemens Medical Solutions USA, Inc.

Recalled Item: Torque wrench used on the bolts for the Symbia T2 model 10275008

The Issue: The torque wrench used to tighten system bolts

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

Class II — Potential Health HazardTerminated
September 18, 2017· MicroPort Orthopedics Inc.

Recalled Item: MicroPort Orthopedics SCHANZ SCREW SELF DRILL

The Issue: The item is being recalled due to an

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

Class II — Potential Health HazardTerminated
September 15, 2017· Zimmer Biomet, Inc.

Recalled Item: 36MM COCR MODULAR HD -6MM

The Issue: One piece from a different lot mixed with

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

Class II — Potential Health HazardTerminated
September 15, 2017· Covidien LLC

Recalled Item: Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA

The Issue: The device cartridge disengaged during use due to

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

Class II — Potential Health HazardTerminated
September 15, 2017· HILL-ROM MANUFACTURING, INC.

Recalled Item: Monarch Airway Clearance System

The Issue: Monarch Electromagnetic Interference (EMI) may disrupt the operation

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

Class II — Potential Health HazardTerminated
September 15, 2017· Encore Medical, Lp

Recalled Item: EMPOWR PS KNEE(TM) e+

The Issue: It was reported that an implant labeled as

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

Class II — Potential Health HazardTerminated
September 15, 2017· Encore Medical, Lp

Recalled Item: EMPOWR PS KNEE(TM) e+

The Issue: It was reported that an implant labeled as

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

Class II — Potential Health HazardTerminated
September 15, 2017· Hologic, Inc

Recalled Item: Panther(R) System

The Issue: An incorrect incubator was installed on one Panther

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

Class II — Potential Health HazardTerminated
September 15, 2017· Cepheid

Recalled Item: Xpert EV Assay

The Issue: Customers have reported a higher than expected number

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

Class II — Potential Health HazardTerminated
September 14, 2017· C.R. Bard, Inc.

Recalled Item: HydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters per box

The Issue: Several instances of a catheter caught in the

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

Class II — Potential Health HazardTerminated