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 29101–29120 of 38,428 recalls

October 20, 2015· Ameditech Inc

Recalled Item: 11 Panel Dip Card (OPI 2000)

The Issue: Ameditech is recalling drug abuse tests because they

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

Class II — Potential Health HazardTerminated
October 20, 2015· Ameditech Inc

Recalled Item: 12-Panel Dip Drug Screen with adulterant

The Issue: Ameditech is recalling drug abuse tests because they

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

Class II — Potential Health HazardTerminated
October 20, 2015· Ameditech Inc

Recalled Item: Micro Screen 6 Panel Cup with Adult (AU)

The Issue: Ameditech is recalling drug abuse tests because they

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

Class II — Potential Health HazardTerminated
October 20, 2015· Ameditech Inc

Recalled Item: ArcPoint Labs 10 Panel Dip Screen (OXY)

The Issue: Ameditech is recalling drug abuse tests because they

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

Class II — Potential Health HazardTerminated
October 20, 2015· Ameditech Inc

Recalled Item: 11 Panel Cup (OPI2000) w/Adult

The Issue: Ameditech is recalling drug abuse tests because they

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

Class II — Potential Health HazardTerminated
October 20, 2015· Ameditech Inc

Recalled Item: EDI BZO UNCUT SHEET-CARD

The Issue: Ameditech is recalling drug abuse tests because they

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

Class II — Potential Health HazardTerminated
October 20, 2015· Ameditech Inc

Recalled Item: DrugSmart Dip (MET/OPI2)+AMP+BZO+COC+THC

The Issue: Ameditech is recalling drug abuse tests because they

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

Class II — Potential Health HazardTerminated
October 20, 2015· Ameditech Inc

Recalled Item: DrugSmart 10 Test Cup (PCP & MDMA)

The Issue: Ameditech is recalling drug abuse tests because they

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

Class II — Potential Health HazardTerminated
October 20, 2015· Ameditech Inc

Recalled Item: Immutest 10 Pnl Drug Screen Cup w/ Adult

The Issue: Ameditech is recalling drug abuse tests because they

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

Class II — Potential Health HazardTerminated
October 20, 2015· Ameditech Inc

Recalled Item: ProScreen 10 Drug Panel Cassette Test

The Issue: Ameditech is recalling drug abuse tests because they

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

Class II — Potential Health HazardTerminated
October 20, 2015· Ameditech Inc

Recalled Item: The Drug Detection Agency 6 Panel Cup Body and Lid w/Adult (AU)

The Issue: Ameditech is recalling drug abuse tests because they

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

Class II — Potential Health HazardTerminated
October 20, 2015· Ameditech Inc

Recalled Item: Premier Clia Waived 12 panel Tilt Cup

The Issue: Ameditech is recalling drug abuse tests because they

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

Class II — Potential Health HazardTerminated
October 20, 2015· Ameditech Inc

Recalled Item: DrugCheck Pipette 10 Drug Test

The Issue: Ameditech is recalling drug abuse tests because they

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

Class II — Potential Health HazardTerminated
October 20, 2015· Ameditech Inc

Recalled Item: 1 Step 12 Panel Cup

The Issue: Ameditech is recalling drug abuse tests because they

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

Class II — Potential Health HazardTerminated
October 20, 2015· Ameditech Inc

Recalled Item: DrugCheck Waived 12 Panel Cup w/Adult

The Issue: Ameditech is recalling drug abuse tests because they

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

Class II — Potential Health HazardTerminated
October 20, 2015· Ameditech Inc

Recalled Item: iCup Drug Screen Cup

The Issue: Ameditech is recalling drug abuse tests because they

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

Class II — Potential Health HazardTerminated
October 19, 2015· Invivo Corporation

Recalled Item: The system provides the ability to transmit patient data files for storage

The Issue: Display of SpO2 and Non-Invasive Blood Pressure (NIBP)

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

Class II — Potential Health HazardTerminated
October 19, 2015· Synthes (USA) Products LLC

Recalled Item: Synthes Application Instrument for Sternal ZIPFIX. Indications for use include

The Issue: Certain lots of the Application Instrument for Sternal

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

Class II — Potential Health HazardTerminated
October 19, 2015· Bard Peripheral Vascular Inc

Recalled Item: FLAIR Endovascular Stent Graft

The Issue: Bard Peripheral Vascular (BPV) is recalling the Bard

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

Class II — Potential Health HazardTerminated
October 16, 2015· Utah Medical Products, Inc

Recalled Item: Myelo-Nate CSF Sampling Kit

The Issue: Utah Medical is conducting a recall of Myelo-Nate

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

Class II — Potential Health HazardTerminated