Medical Devices Recalls

The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.

Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.

The unexpected internal fault / system diagnostic error to result when a rapid succession of button selections is made to the user interface without waiting for the device to respond to user prompts.

Potential for the lid of the catheter connector to be in the incorrect position.

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."

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

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.

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.

Vital sign monitoring instrument may trigger an error message during blood pressures measurements, Specifically, when the initial inflation pressure is set in the high-pressure range.