DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged into a power source or remains active after buttons are released.
Reason for recall: DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged into a power source or remains active after buttons are released. Distribution: US Nationwide distribution in the state of OH. Quantity: 780 units Lot/code info: UDI/ DI 00749756927864 (each), 50749756927869 (case): Lot Numbers: 59098305, exp 4/1/2027; 59161271, exp 3/1/2025; 59245221, exp 6/1/2025; 59287659, exp 5/1/2025; 59716337, exp 5/1/2025;59866546, exp 12/1/2025; 59962811, exp 11/1/2025; 59996754, exp 12/1/2025; 60104426, exp 11/1/2025
00749756927864, 50749756927869
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.