Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 469–480 of 2,908 recalls
Due to an device without a premarket clearance being incorrectly package and distributed.
Due to an issue (potential breakage) with the shaft for the mounting of the X-ray tube assembly that could potentially result assembly coming off the rotating shaft.
The nasal feeding tube may be occluded
The nasal feeding tube may be occluded
The nasal feeding tube may be occluded
The nasal feeding tube may be occluded
The nasal feeding tube may be occluded
The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanne…
The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanne…
The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanne…
Due to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting in continuous activation.
Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect results.