Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 49–60 of 92 recalls
It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. The bottom (round end) of the Reaction Vessel may have a small protrusion or hair like deformity.…
Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization.
The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.
Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
Potential for undetected, deformed a-traumatic tips.
Foley catheter may have an obstructed lumen, which may result in an inability to drain the bladder, of urine and may include pelvic or abdominal pain, flank pain, bladder dysfunction, obstructive uropathy, acute kidney i…
Beckman Coulter identified that the Unsaturated Iron Binding Capacity (UIBC) assay is not meeting their labeled hemoglobin interference claims of no significant interference (i.e., less than 10%) up to 200 mg/dL hemoglob…
Potential for external cassette leaks
Potential for external cassette leaks
Potential for external cassette leaks
Potential for external cassette leaks