Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 529–540 of 595 recalls
Affected devices have a smaller diameter than expected and may potentially result in inadequate ventilation to the patient. Patient may experience hypoxia, underdose, or cardiopulmonary collapse.
There is the potential for missing motor mounting screws, which may have occurred during the servicing process.
There is the potential for missing motor mounting screws, which may have occurred during the servicing process.
Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall apposition and/or braid deformation (fish-mouthing/braid narrowing/braid collapse) noted during procedure and post-proced…
Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall apposition and/or braid deformation (fish-mouthing/braid narrowing/braid collapse) noted during procedure and post-proced…
Atherectomy Catheter eIFU updated to clarify and emphasize procedural steps intended to reduce the likelihood of catheter breakage events.…
Due to an observed trend of neurovascular events
Multi-Function Ventilators were serviced using incorrect parts which have the potential to cause unexpected shutdown, or when using an active circuit could result in inaccurate tidal volume monitor, not triggering on pat…
Possibility of the patient falling from the table related to the mattress used on the patient table.
Possibility of the patient falling from the table related to the mattress used on the patient table.
Possibility of the patient falling from the table related to the mattress used on the patient table.
Possibility of the patient falling from the table related to the mattress used on the patient table.