1,320 recalls tagged with “fda regulated”.
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
undeclared allergen (Wheat) on ready to eat sandwiches.
Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.
The device does not bear a unique device identifier.
Due to software issue, radiology reports may not be fully displayed when viewing.
The device does not bear a unique device identifier.
The device does not bear a unique device identifier.
The device does not bear a unique device identifier.
The device does not bear a unique device identifier.
The device does not bear a unique device identifier.
The device does not bear a unique device identifier.
The device does not bear a unique device identifier.
Penner Patient Care recalls 190 Bathing Spa devices nationwide after discovering the units lack a unique device identifier. The issue involves missing UDI on the device. Stop using the device immediately and follow the recall instructions.
Product label does not list ingredients including major food allergen: sesame. Additional undeclared ingredients include: poppy seeds, dried garlic, dried onion, and sea salt
Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a potential for lost of control of the device potentially resulting in minor or major injuries.