Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–12 of 28 recalls
Due to off-the-shelf display port component that has audio/video failures
Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm function, which may result in the backup alarm not activating during loss of p…
Yttrium-stabilized zirconium oxide discs for fixed all-ceramic dental restorations may have reduced or missing dentin layer and when used clinically in the patient's mouth there is an increased risk of fractures under f…
Due to incorrect incubation process being performed on product.
Due to incorrect incubation process being performed on product.
Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure (PIP) was conducted, and the inability to perform the device's intende…
Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester).
Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under all intended high-pressure conditions during production testing, so an oxygen leak condition could occu…
Multi-parameter command module has a circuit board issue and when in Auto mode, Cardiac Output (CO) measurement may activate early, resulting in Bad Curve error with no CO measurement or Irregular Curve error with CO mea…
Due to pediatric defibrillator electrode delamination
Retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer.
Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.