DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06 recallZ-0307-2025 · DeRoyal Industries Inc · initiated Oct 3, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from DeRoyal Industries Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Under Investigation by firm
What the company is doing
DeRoyal issued an URGENT! DEROYAL RECALL NOTICE to its consignees on 10/03/2024 via email. The notice explained the issue, potential risk, and requested the return of the affected packs. If the affected product was further distributed, the notice directed the distributor to notify its customers. This may be achieved directly by forwarding the recall notification and notify DeRoyal that you have done so, or the distributor may provide DeRoyal with your customer listing allowing them to contact your customers.
Recall details
- Recall number
- Z-0307-2025
- Status
- Open, Classified
- Initiated by the company
- Oct 3, 2024
- Posted by the FDA
- Nov 5, 2024
- Recalling firm
- DeRoyal Industries Inc
- Quantity
- 160 units
- Product code
- LRO
- FDA submissions
- K842648
- Distribution
- US Nationwide distribution in the state of OH.
Product description
DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06
Code information (models, lots, serial numbers)
UDI/ DI 00749756916646 (each), 50749756916641 (case): Lot Numbers: lot 59839716 exp 12/1/2025
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- DeRoyal 89-9342Deroyal Industries, Inc. · General surgery tray1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 95509).
- Z-0306-2025 · Open, ClassifiedDeRoyal C-SECTION TRACEPACK, REF 89-9338-06
- Z-0308-2025 · Open, ClassifiedDeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06
- Z-0309-2025 · Open, ClassifiedDeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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