Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 373–384 of 1,678 recalls
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators.…
Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery.…
Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery.…
Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery.…
A defect has been identified in the manufacture of the Fresh Roast Systems ColorTrack instrument model number BENCH R-100 which could under very rare specific misuse circumstances potentially allow human access to infrar…
Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the handheld camera to the robotic end…
3.0mm surgical knives labeled and packaged as 2.2mm surgical knives.
Due to incorrect functional length on device labeling.
Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in custom convenience kits.
Software in development inadvertently made available for customer use. Use of this software version can result in clinical information being associated with the incorrect patient.…
Sterile wound dressing, lacks sterility assurance
Fingerprint scanner may overheat to a temperature to cause 1st degree burn.