All Recalls

92,900 total recalls in our database

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.

Sep 3, 2025 Other Medical Devices Nationwide View Details β†’

MAGNETOM Skyra fit. Model Number: 10849580.

Siemens Medical Solutions USA

πŸ₯ Medical Devices Class I - Dangerous

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.

Aug 28, 2025 Other Medical Devices Nationwide View Details β†’
πŸ₯ Medical Devices Class I - Dangerous

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.

Sep 3, 2025 Other Medical Devices Nationwide View Details β†’

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

Sep 9, 2025 Diagnostic Equipment Nationwide View Details β†’

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.

Sep 3, 2025 Other Medical Devices Nationwide View Details β†’

The bovine carotid arteries used to produce the impacted grafts from affected lots were sourced using raw material from a supplier that had not been reviewed and approved by the appropriate regulatory authority.

Sep 2, 2025 Other Medical Devices Nationwide View Details β†’

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.

Sep 3, 2025 Other Medical Devices Nationwide View Details β†’

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.

Sep 3, 2025 Other Medical Devices Nationwide View Details β†’

Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards

Jun 26, 2025 Diagnostic Equipment View Details β†’

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.

Sep 3, 2025 Other Medical Devices Nationwide View Details β†’

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

Aug 29, 2025 Surgical Instruments Nationwide View Details β†’

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.

Sep 3, 2025 Other Medical Devices Nationwide View Details β†’
πŸ₯ Medical Devices Class I - Dangerous

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.

Aug 28, 2025 Other Medical Devices Nationwide View Details β†’

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

Aug 29, 2025 Surgical Instruments Nationwide View Details β†’

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.

Sep 3, 2025 Other Medical Devices Nationwide View Details β†’

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

Aug 29, 2025 Surgical Instruments Nationwide View Details β†’
πŸ₯ Medical Devices Class I - Dangerous

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.

Aug 28, 2025 Other Medical Devices Nationwide View Details β†’

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.

Jul 31, 2025 Diagnostic Equipment Nationwide View Details β†’

On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously with an Immunoassay (IA) test, if the IA test is processed between the CC tests, CC sample status will remain In Progress with no errors, may cause processing delays.

Aug 4, 2025 Other Medical Devices View Details β†’