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A potential shock hazard exists if the night light is damaged.
Lack of assurance of sterility
Malformation of the Hem-o-lok SMX clip.
DiaSorin Anti-Cardiolipin IgA kit's positive control is out of acceptable limits.
Excessive wear of the hanger bar bolt, that connects the lift arm to the sling spreader bar, may cause the bolt to snap allowing the patient to fall.
Product labeled as size 3.8x6 mm implant may actually be size 4.3x6 mm implant.
Software problem that may cause unintended emission of laser radiation.
Hydrophilic powder wound dressing, sterilized at a dosage which subsequently failed a sterility audit, was distributed.
Microorganisms were detected in associated tissue.
Due to limitations in the operating software, the acquired scan may not be processed properly.
Product label lacks the symbols specifying the meaning of the manufacturing and expiration date.
Screw size included in system was incorrect
The cards were stamped with an incorrect card code that causes the system to read and analyze the cards incorrectly.
System failed to meet the mA's accuracy specfications at low mA's values
Catheter distal tip may separate