1,320 recalls tagged with “fda regulated”.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Production assembly error resulting in the potential for reversed articulation, where moving the lever forward caused the probe tip to anteflex rather than retroflex, and vice versa.
Product which was on FDA hold for high levels of Nitrofuran was inadvertently distributed.
Product does not declare wheat in the allergen statement.
Baxter Healthcare recalls 49,200 CONTINU-FLO IV Solution Sets distributed nationwide in the United States. IV sets may leak. Healthcare facilities and patients should stop using the device immediately and follow Baxter's recall instructions.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Bulk packaged dietary ingredient manufacturer product label does not declare Milk as an allergen ingredient.
Wound dressing may have foreign matter on the product.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Potential for device to overheat during operation f the circulation pressure calibration was not performed or had been performed incorrectly, and the low-pressure alarm is not triggered.
The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa.