Home / Recalls / Medical Devices
DeRoyal Industries Inc recalls DeRoyal C-SECTION TRACEPACK, REF 89-9338-06
Recalled November 13, 2024 · FDA recall Z-0306-2025 · DeRoyal Industries
Hazard
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. · FDA Class II
Units
780 units
Sold at
US Nationwide distribution in the state of OH.
Description
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.
Product
DeRoyal C-SECTION TRACEPACK, REF 89-9338-06
Manufacturer(s)
DeRoyal Industries Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →