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: 28679 kits Lot/code info: REF CDS860015W: UDI/DI 10195327349509 (each) 40195327349500, (case), Lot Numbers: CDS860015W; REF CDS860015W: UDI/DI 10195327349509 (each) 40195327349500, (case), Lot Numbers: CDS860015W; REF CDS860015W: UDI/DI 10195327349509 (each) 40195327349500, (case), Lot Numbers: CDS860015W; REF CDS860015X: UDI/DI 10195327647513 (each) 40195327647514, (case), Lot Numbers: CDS860015X; REF CDS860015X: UDI/DI 10195327647513 (each) 40195327647514, (case), Lot Numbers: CDS860015X; REF CDS860015X: UDI/DI 10195327647513 (each) 40195327647514, (case), Lot Numbers: CDS860015X; REF CDS860016R: UDI/DI 10195327349479 (each) 40195327349470, (case), Lot Numbers: CDS860016R; REF CDS860016S: UDI/DI 10195327647520 (each) 40195327647521, (case), Lot Numbers: CDS860016S; REF CDS860062S: UDI/DI 10195327140632 (each) 40195327140633, (case), Lot Numbers: CDS860062S; REF CDS860062S: UDI/DI 10195327140632 (each) 40195327140633, (case), Lot Numbers: CDS860062S; REF CDS860062S: UDI/DI 10195327140632 (each) 40195327140633, (case), Lot Numbers: CDS860062S; REF CDS860062S: UDI/DI 10195327140632 (each) 40195327140633, (case), Lot Numbers: CDS860062S; REF CDS860062S: UDI/DI 10195327140632 (each) 40195327140633, (case), Lot Numbers: CDS860062S; REF CDS860194I: UDI/DI 10193489445152 (each) 40193489445153, (case), Lot Numbers: CDS860194I; REF CDS860194I: UDI/DI 10193489445152 (each) 40193489445153, (case), Lot Numbers: CDS860194I; REF CDS860194I: UDI/DI 10193489445152 (each) 40193489445153, (case), Lot Numbers: CDS86019
10195327349509, 40195327349500, 10195327647513, 40195327647514, 10195327349479, 40195327349470, 10195327647520, 40195327647521, 10195327140632, 40195327140633, 10193489445152, 40193489445153, 10195327349486, 40195327349487, 10195327241759, 40195327241750, 10195327647698, 40195327647699, 10193489848342, 40193489848343, 10195327627324, 40195327627325, 10195327451233, 40195327451234, 10195327238360, 40195327238361, 10193489862218, 40193489862219, 10195327237639, 40195327237630, 10195327412012, 40195327412013, 10195327412043, 40195327412044, 10195327404543, 40195327404544, 10195327357276, 40195327357277, 10889942826612, 40889942826613
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.