DeRoyal Children's Surgical Pack Recalled for Smoke Pencil Malfunction
DeRoyal is recalling certain lots of children's surgical procedure packs due to reports that the included Stryker smoke evacuation pencil may activate without manual input or remain active after buttons are released.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for device malfunction without documented illnesses, injuries, or hospitalizations. Per the severity rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, fitting the High (3) criteria.
Plain-English summary
DeRoyal Industries Inc is recalling specific lots of its Children's General Tracepack (Reference 89-9342-06), a surgical procedure pack used in medical settings.
The recall was initiated due to reports that the Stryker SafeAir Smoke Evacuation Pencil contained within these packs activates without manual input when plugged into a power source, or remains active after buttons are released. This malfunction creates a potential safety concern during surgical procedures.
The affected products are distributed nationwide, with specific documentation noting distribution in Ohio. The recalled lot number is 59839716, with an expiration date of December 1, 2025.
Healthcare providers and facilities that have received these packs should stop using the affected products and contact DeRoyal Industries Inc for replacement or return instructions.
The recalled product
- Product
- DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06
- Manufacturer
- DeRoyal Industries Inc
- Affected units
- 160
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/ DI 00749756916646 (each)
- 50749756916641 (case): Lot Numbers: lot 59839716 exp 12/1/2025
Distribution
Part of a larger recall action
This product is one of 4 recalled by DeRoyal Industries Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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