Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 145–156 of 163 recalls
Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use.…
Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use.…
Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use.…
Recent post-market surveillance data suggests a possible association of higher microbial contamination levels from TJF duodenoscopes when manual cleaning was delayed beyond one hour and a presoak was performed, compared…
Preset treatment parameters are not consistently being used in accordance with the IFU.
Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.