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.
Showing 14301–14320 of 38,428 recalls
Recalled Item: TDDA Drugs of Abuse Cup(AMT Item/ AMT Description): TDDA-6MBAU-CUP /"TDDA
The Issue: Various immunoassay enzymes failed product performance, thereby the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Henry Schein One Step + DOA Cup (AMT Item Number/
The Issue: Various immunoassay enzymes failed product performance, thereby the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: First Check 14 Panel Drug Cup: (BMC style)
The Issue: Various immunoassay enzymes failed product performance, thereby the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iCup Dx14 Drug Screen Cup(AMT Item Number/ AMT Description): X11-I-DXA-2147-011/
The Issue: Various immunoassay enzymes failed product performance, thereby the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: First Check 2 Panel Drug Cup: (THC/COC)
The Issue: Various immunoassay enzymes failed product performance, thereby the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QuickTox Drug Screen DipCard(AMT Item/ AMT Description): QT70/ "QuickTox¿ Drug
The Issue: Various immunoassay enzymes failed product performance, thereby the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ProScreen" Drugs of Abuse Test (AMT Item/ AMT Description): PSD-6MB/
The Issue: Various immunoassay enzymes failed product performance, thereby the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: First Check 4 Panel Drug Cup: COC/MET1000/OPI2000/THC): (THC/COC)
The Issue: Various immunoassay enzymes failed product performance, thereby the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alere iScreen Single Drug Detection (AMT Item Number/ AMT Description):
The Issue: Various immunoassay enzymes failed product performance, thereby the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alere iScreen Multi Drug Detection (AMT Item Number/ AMT Description):
The Issue: Various immunoassay enzymes failed product performance, thereby the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MicroTox (AMT Item Number/ AMT Description): MTPA-6MBAU / "MicroTox...
The Issue: Various immunoassay enzymes failed product performance, thereby the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oratect III Oral Fluid Drug Screen Device (AMT Item Number/
The Issue: XXX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MicroScreen (AMT Item Number/ AMT Description): MSCA-6MBAU/ "MicroScreen...
The Issue: Various immunoassay enzymes failed product performance, thereby the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alere iCup Drug Detection (AMT Item Number/ AMT Description): I-DXA-10/
The Issue: Various immunoassay enzymes failed product performance, thereby the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fastect¿ II Drug Screen Dipstick Test Single Drug Detection (AMT
The Issue: Various immunoassay enzymes failed product performance, thereby the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: First Check 1 Panel Drug Cup: (THC)
The Issue: Various immunoassay enzymes failed product performance, thereby the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CLIA Waived Rapid Drug Test (AMT Item Number/ AMT Description):
The Issue: Various immunoassay enzymes failed product performance, thereby the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Speed Stitch Needle Cassette
The Issue: Due to a supplier error where a portion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dual Mobility Vivacit-E Bearing
The Issue: The outer package is labeled as a Size
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NM/CT 850 Model Number: H3907AD
The Issue: Rotor bearing screws were found loose on detector
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.