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.
Reason for recall: 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. Distribution: US Nationwide distribution. Quantity: 142 kits Lot/code info: 1) REF DYNJ00281P: UDI/DI 10195327411954 (each), 40195327411955 (case), Lot Numbers: 23GMD333, 23HMC426; 2) REF DYNJ68213C: UDI/DI 10195327511999 (each), 40195327511990 (case), Lot Numbers: 23IMI021, 23KMJ671.
10195327411954, 40195327411955, 10195327511999, 40195327511990
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.