Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 517–528 of 607 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.…
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…
Potential for the presence of visible foreign matter.
Preset treatment parameters are not consistently being used in accordance with the IFU.
Devices for the affected lot were not assembled according to product specifications. The distraction rod outer diameter was assembled with a 5.5mm rod versus the required 5.0mm.
IVX Station Reconstitution Transfer Sets were shipped in advance of the IVX Station upgrade and not intended for clinical use but are engineering devices intended for use during set up and system calibration.…
The potential for cracks forming in the breathing circuit hose.
The potential for cracks forming in the breathing circuit hose.
The potential for cracks forming in the breathing circuit hose.
The potential for cracks forming in the breathing circuit hose.
The potential for cracks forming in the breathing circuit hose.