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 14901–14920 of 38,428 recalls
Recalled Item: PrimeStore Molecular Transport Medium (PS-MTM)
The Issue: The tubes may have been delivered to some
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MagNA Pure 96 Instrument
The Issue: When using Sample Transfer protocol version 3.0, the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COOPERSURGICAL Os FinderTM Cervical Dilator
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DUFNER Instrumente GmbH-De Bakey Slim Needleholder- intended to hold a
The Issue: Tungsten carbide plate, which is intended to hold
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HYGENIC Wingless Fiesta Kit
The Issue: Multiple Coltene batches of the product have a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HYGENIC Winged Fiesta Kit
The Issue: Multiple Coltene batches of the product have a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HYGENIC Dental Dam Forceps
The Issue: Multiple Coltene batches of the product have a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HYGENIC Simple Dam Kit
The Issue: Multiple Coltene batches of the product have a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flow Coupler Monitor
The Issue: A firmware issue may cause the GEM1020M-2 Flow
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EasyDiagnost Eleva DRF
The Issue: Thermo switches in the main power supply for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zenith Alpha Abdominal Endovascular Graft
The Issue: Identified products may contain a damaged bushing within
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RUSCH LASERTUBE (Rubber)
The Issue: Teleflex is initiating a voluntary recall for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Safe-T PLUS Thora-Para 5 Fr Catheter Drainage Tray
The Issue: The Universal Drainage Set (UDS) may contain valves
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Safe-T-Centesis PLUS 8 Fr Catheter Drainage Tray
The Issue: The Universal Drainage Set (UDS) may contain valves
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Safe-T PLUS Thora-Para 8 Fr Catheter Drainage Tray
The Issue: The Universal Drainage Set (UDS) may contain valves
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Thora-Para 5 Fr Catheter Drainage Tray
The Issue: The Universal Drainage Set (UDS) may contain valves
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Safe-T-Centesis 6 Fr Catheter Drainage Tray w/o Lidocaine
The Issue: The Universal Drainage Set (UDS) may contain valves
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Safe-T-Centesis 8 Fr Catheter Drainage Tray
The Issue: The Universal Drainage Set (UDS) may contain valves
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Safe-T PLUS Thora-Para 5 Fr Non-Valved Catheter Drainage Tray
The Issue: The Universal Drainage Set (UDS) may contain valves
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Safe-T-Centesis PLUS 6 Fr Catheter Drainage Tray
The Issue: The Universal Drainage Set (UDS) may contain valves
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.