All Recalls

Product is contaminated with Salmonella

Mislabeled: Product may contain undeclared sesame seeds

Undeclared Almonds, Sesame, Red 40, Red 3, and Blue 1

Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity

Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns

Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity

Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns

Failed Dissolution Specifications.

The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

Device used for unilateral or bilateral occlusion of blood flow to the lower limbs has a potential manufacturing defect that may compromise the structural integrity of the device and device performance during use.

Potential for breaches in the sterile barrier packaging, compromising sterility assurance.

Potential for breaches in the sterile barrier packaging, compromising sterility assurance.

Potential that the measured value may be smaller than the actual area.

If the radiosurgery system triggers a proximity error message during a long gantry move (greater-than180 degrees), and a subsequent proximity error message occurs after the automatic reduction of speed, a software defect could potentially lead the collimator to collide with patient shoulders or the patient table.

The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.

Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."