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 22061–22080 of 38,428 recalls

December 27, 2017· Mako Surgical Corporation

Recalled Item: Makoplasty RIO Standard System

The Issue: Communication-connection error

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

Class II — Potential Health HazardTerminated
December 27, 2017· Ormco/Sybronendo

Recalled Item: Elements Obturation Unit (EOU) used with respective Buchanan Heat Pluggers

The Issue: Buchanan Heat Pluggers will possibly overheat while used

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

Class II — Potential Health HazardTerminated
December 27, 2017· LITTLE RAPIDS CORPORATION

Recalled Item: EMS products from Graham Medical

The Issue: The secondary supplier provided material was within specification

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

Class II — Potential Health HazardTerminated
December 22, 2017· DePuy Mitek, Inc., a Johnson & Johnson Co.

Recalled Item: LATARJET EXPERIENCE Sharp Curved Ostetome Product Usage: The Latarjet EXPERIENCE

The Issue: Reports of product loosening or coming unscrewed from

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

Class II — Potential Health HazardTerminated
December 22, 2017· Arrow International Inc

Recalled Item: Multi-Lumen Hemodialysis Catheterization Kit for High Volume Infusions

The Issue: Certain lots of cardiovascular catheters may not be

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

Class II — Potential Health HazardTerminated
December 22, 2017· Arrow International Inc

Recalled Item: ARROWg+ard Blue¿ CVC Kit (1) Part Number (PN): CDC-24301-1A

The Issue: Certain lots of cardiovascular catheters may not be

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

Class II — Potential Health HazardTerminated
December 22, 2017· Arrow International Inc

Recalled Item: (1) Central Venous Catheterization Kit

The Issue: Certain lots of cardiovascular catheters may not be

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

Class II — Potential Health HazardTerminated
December 22, 2017· Arrow International Inc

Recalled Item: AGB+ Multi Lumen CVC Kit (1) Part Number (PN): CDC-42703-B1A

The Issue: Certain lots of cardiovascular catheters may not be

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

Class II — Potential Health HazardTerminated
December 22, 2017· Arrow International Inc

Recalled Item: (1) Access Tray

The Issue: Certain lots of cardiovascular catheters may not be

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

Class II — Potential Health HazardTerminated
December 22, 2017· Arrow International Inc

Recalled Item: ARROWg+ard Blue¿ Two-Lumen Hemodialysis Catheterization Kit for High Volume...

The Issue: Certain lots of cardiovascular catheters may not be

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

Class II — Potential Health HazardTerminated
December 22, 2017· Arrow International Inc

Recalled Item: (1) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for

The Issue: Certain lots of cardiovascular catheters may not be

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

Class II — Potential Health HazardTerminated
December 22, 2017· Arrow International Inc

Recalled Item: (1) MAC Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters

The Issue: Certain lots of cardiovascular catheters may not be

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

Class II — Potential Health HazardTerminated
December 22, 2017· Arrow International Inc

Recalled Item: (1) Arterial Catheterization Kit

The Issue: Certain lots of cardiovascular catheters may not be

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

Class II — Potential Health HazardTerminated
December 22, 2017· Arrow International Inc

Recalled Item: Arrowg+ard Blue(R) PSI Kit

The Issue: Certain lots of cardiovascular catheters may not be

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

Class II — Potential Health HazardTerminated
December 22, 2017· Arrow International Inc

Recalled Item: (1) Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port

The Issue: Certain lots of cardiovascular catheters may not be

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

Class II — Potential Health HazardTerminated
December 22, 2017· Arrow International Inc

Recalled Item: AGB+ Multi Lumen Central Venous Catheterization (CVC) Kit (1) Part

The Issue: Certain lots of cardiovascular catheters may not be

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

Class II — Potential Health HazardTerminated
December 22, 2017· Arrow International Inc

Recalled Item: Arrow¿ Pressure Injectable Two-Lumen PICC Kit

The Issue: Certain lots of cardiovascular catheters may not be

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

Class II — Potential Health HazardTerminated
December 22, 2017· Arrow International Inc

Recalled Item: Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard Technology

The Issue: Certain lots of cardiovascular catheters may not be

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

Class II — Potential Health HazardTerminated
December 22, 2017· Roche Diagnostics Corporation

Recalled Item: Elecsys BRAHMS PCT Immunoassay for the in vitro quantitative determination

The Issue: Product exhibits a decreased recovery of patient samples

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

Class II — Potential Health HazardTerminated
December 22, 2017· Medtronic Sofamor Danek USA Inc

Recalled Item: Medtronic ANGLED DRILL

The Issue: Medtronic has discovered the product lot in question

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

Class II — Potential Health HazardTerminated