FDAFDA · Food and drugs·Recall number Z-0306-2025
DeRoyal C-SECTION TRACEPACK, REF 89-9338-06
Published November 13, 2024 · Recall initiated: October 3, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- DeRoyal Industries Inc
- Distributor
- US Nationwide distribution in the state of OH.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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