Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1,429–1,440 of 3,866 recalls
Retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer.
Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.
Butyrate tube cracks during actuation, rendering product unusable.
Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.
Lack of Remote Interlock Connector - required per 21 CFR 1040.10(f)(3)
Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample.
Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume therapy, and the patient experienced a recurrence of underlying pain sympt…
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification.…
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification.…
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification.…
Safety and efficacy of dialysis acid concentrate cannot be assured
Safety and efficacy of dialysis acid concentrate cannot be assured