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 13261–13280 of 38,428 recalls
Recalled Item: Steris CO2MPACT Endoscopic Insufflator system
The Issue: An internal tubing component in the flow path
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ConMed 50L abdominal insufflator
The Issue: An internal tubing component in the flow path
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Central Screw 6.5x25mm - Product Usage: used as a sterile
The Issue: Zimmer Biomet is conducting a lot specific medical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SARS-CoV-2 Antigen Test
The Issue: QIAGEN has become aware of the potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BARD MARQUEE Disposable Core Biopsy Instruments XX.Xcm
The Issue: Due to the Penetration Depth Switch used to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PHYSIO CONTROL LIFEPAK CR2 Defibrillator 3321605-xxx The LIFEPAK CR2...
The Issue: Due to complaints received regarding missing lid magnets
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products VersaTips - Product Usage: used to dispense
The Issue: A deformity affecting a specific lot of VITROS¿
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Power Injectable CT Port insertion kits - Product Usage: is
The Issue: The 5F Dignity CT Port kits were packaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Parietex hydrophilic anatomical mesh 15 cm x 10 cm
The Issue: incorrect device is contained in the package. The
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ENROUTE Transcarotid Stent System
The Issue: Due to complaints received that the tip/nose cone
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bemer-Set/ Pro-Set for the following models: REF. 410201 (BEMER Pro-Set)
The Issue: There potential that electromagnetic fields generated in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Grasper/Retriever
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Grasper/Retriever
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: The external drainage system failed to meet Pyrogen
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bard Clean-Cath Intermittent Catheter
The Issue: The device catheter tip was cut off (no
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Slush + Warmer Disc Drape
The Issue: Slits were identified in a low quantity of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests
The Issue: Observations of potential false positive results in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Cerebro Spinal Fluid Flow Control Valves and Shunts. STRATA
The Issue: for variation in radiopaque marking visibility under
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic PS Medical Cerebro Spinal Fluid (CSF)-Flow Control Valves for
The Issue: for variation in radiopaque marking visibility under
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Delta CSF (Cerebro Spinal Fluid) -Flow Control Valves for
The Issue: for variation in radiopaque marking visibility under
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.