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: 20941 kits Lot/code info: REF 24BBC860: UDI/DI 10195327601492 (each), 40195327601493 (case), Lot Numbers: 24BBC860; REF 24BBU607: UDI/DI 10193489848434 (each), 40193489848435 (case), Lot Numbers: 24BBU607; REF 24CBU583: UDI/DI 10193489848434 (each), 40193489848435 (case), Lot Numbers: 24CBU583; REF 24EBE546: UDI/DI 10193489848434 (each), 40193489848435 (case), Lot Numbers: 24EBE546; REF 23GBF733: UDI/DI 10193489445442 (each), 40193489445443 (case), Lot Numbers: 23GBF733; REF 24ABG140: UDI/DI 10193489445442 (each), 40193489445443 (case), Lot Numbers: 24ABG140; REF 24BBN521: UDI/DI 10193489445442 (each), 40193489445443 (case), Lot Numbers: 24BBN521; REF 24CBR696: UDI/DI 10193489445442 (each), 40193489445443 (case), Lot Numbers: 24CBR696; REF 24EBK857: UDI/DI 10193489445442 (each), 40193489445443 (case), Lot Numbers: 24EBK857; REF 24ABH200: UDI/DI 10195327584481 (each), 40195327584482 (case), Lot Numbers: 24ABH200; REF 24BBG787: UDI/DI 10195327584481 (each), 40195327584482 (case), Lot Numbers: 24BBG787; REF 24CBI679: UDI/DI 10195327584481 (each), 40195327584482 (case), Lot Numbers: 24CBI679; REF 23GBS700: UDI/DI 10195327185220 (each), 40195327185221 (case), Lot Numbers: 23GBS700; REF 24ABG363: UDI/DI 10195327185220 (each), 40195327185221 (case), Lot Numbers: 24ABG363; REF 24BBH950: UDI/DI 10195327584498 (each), 40195327584499 (case), Lot Numbers: 24BBH950; REF 24BBR420: UDI/DI 10195327584498 (each), 40195327584499 (case), Lot Numbers: 24BBR420; REF 24CBV474: UDI/DI 10195327584498 (each), 40195327584499 (
10195327601492, 40195327601493, 10193489848434, 40193489848435, 10193489445442, 40193489445443, 10195327584481, 40195327584482, 10195327185220, 40195327185221, 10195327584498, 40195327584499, 10195327584450, 40195327584451, 10195327584511, 40195327584512, 10195327584474, 40195327584475, 10195327584467, 40195327584468, 10195327601485, 40195327601486, 10195327601508, 40195327601509, 10195327412029, 40195327412020, 10195327404550, 40195327404551, 10195327404574, 40195327404575, 10195327304331, 40195327304332, 10195327356750, 40195327356751, 10195327618360, 40195327618361, 10195327556495, 40195327556496, 10198459237010, 40198459237011
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.