DeRoyal recalls certain lots of Children's Orthopedic Tracepack surgical packs containing a Stryker SafeAir Smoke Evacuation Pencil that may activate without manual input or remain active after button release. Affected units include specific lot numbers with expiration dates.
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.
DeRoyal is recalling specific lots of Children's Orthopedic Tracepack surgical packs that contain a Stryker SafeAir Smoke Evacuation Pencil. This pencil may activate without manual input or stay active after buttons are released, potentially causing unintended smoke evacuation.
The Stryker SafeAir Smoke Evacuation Pencil may activate without manual input when plugged in or stay active after buttons are released. This could lead to unintended smoke evacuation from the surgical pack, which might interfere with medical procedures or cause discomfort.
Parents and caregivers of children using this surgical pack product are most at risk. The recall affects specific lot numbers of the DeRoyal Children's Orthopedic Tracepack.
Check the product label for lot numbers: 58828011 (expires 11/1/2024), 59098364 (expires 1/1/2026), 59259658 (expires 7/1/2025), or 59839687 (expires 11/1/2025). The product is a DeRoyal Children's Orthopedic Tracepack with UDI/DI numbers 00749756917292 or 00749756917297.
Look for lot numbers 58828011, 59098364, 59259658, or 59839687 on the DeRoyal Children's Orthopedic Tracepack.
The Stryker SafeAir Smoke Evacuation Pencil may activate without manual input when plugged in or stay active after buttons are released, potentially causing unintended smoke evacuation.
Lot numbers 58828011 (expires 11/1/2024), 59098364 (expires 1/1/2026), 59259658 (expires 7/1/2025), and 59839687 (expires 11/1/2025).
The recall does not require immediate stop use; however, affected units should be checked and disposed of if they match the lot numbers.
We’ve drafted a message you can send DeRoyal to request your refund or repair — edit it as you like.
Subject: Recall Z-0308-2025 — DeRoyal DeRoyal Hello, I own a DeRoyal that is covered by recall Z-0308-2025 from DeRoyal. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
