DeRoyal recalls certain surgical procedure packs containing a Stryker SafeAir Smoke Evacuation Pencil that may activate without manual input or remain active after button release. Affected units have specific lot numbers and 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 surgical procedure packs that include a Stryker SafeAir Smoke Evacuation Pencil. The pencil may activate without manual input or stay active after buttons are released, potentially causing unintended smoke evacuation during procedures.
The pencil may activate without manual input when plugged in or stay active after buttons are released. This could cause unintended smoke evacuation during surgical procedures, potentially disrupting the operation or causing safety hazards.
Surgical teams and medical facilities using the DeRoyal C-SECTION TRACEPACK with the specified lot numbers and expiration dates are most at risk. Patients and staff during procedures could be affected if the pencil malfunctions.
Check the lot numbers on the packaging: 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), and 60104426 (exp 11/1/2025).
Look for lot numbers 59098305 through 60104426 on the packaging or case labels.
The Stryker SafeAir Smoke Evacuation Pencil may activate without manual input when plugged in or remain active after buttons are released, potentially causing unintended smoke evacuation during procedures.
Check the lot numbers on the packaging: 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), and 60104426 (exp 11/1/2025).
The recall does not specify a remedy, so contact DeRoyal for guidance on next steps.
We’ve drafted a message you can send DeRoyal to request your refund or repair — edit it as you like.
Subject: Recall Z-0306-2025 — DeRoyal DeRoyal Hello, I own a DeRoyal that is covered by recall Z-0306-2025 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.
