Medical device recalls

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks.

Automated cell-locating device barcode reader may read the barcode of the previously processed slide resulting in a misattribution of diagnostic results.

Due to a software error code that crashes during acquisition on patient sample when running customer defined acquisition protocol. This may lead to delayed patient results.

Due to incorrect product label (Incorrect product name identified on outer packaging).

Medtronic personnel observed trace amounts of dry blood on the external carton label and Instructions for Use (IFU) in five boxes of one lot of ACT Cartridges.

A labeling error was identified on the affected product. The expiration date on the kit box label and on the vial labels incorrectly stated the expiration date as 2026-01-16. The correct expiration date should be 2027-01-17.

Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.

Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.

Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.

Due to distributing the measles IgG IVD without a premarket approved/cleared.

Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in procedure inconvenience and/or hemorrhage.

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.