DeRoyal Children's Orthopedic Tracepack Smoke Evacuation Pencil Malfunction Recall
DeRoyal is recalling 384 units of Children's Orthopedic TracePacks containing a Stryker smoke evacuation pencil that may activate unexpectedly or fail to deactivate, posing a burn risk during surgery.
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 of a surgical device with a reported malfunction posing potential burn injury risk. No illnesses or injuries have been reported; the hazard remains theoretical based on the device's failure to respond correctly to user input.
Plain-English summary
DeRoyal Industries Inc is recalling 384 units of the DeRoyal Children's Orthopedic Tracepack (model 89-9349-06) distributed in Ohio. These surgical procedure packs contain a Stryker SafeAir Smoke Evacuation Pencil.
The recall was initiated after Stryker received reports that the smoke evacuation pencil may activate without manual input when plugged into a power source, or may remain active after buttons are released. This malfunction could pose a burn risk during surgical procedures.
Affected lot numbers are 58828011 (expires 11/1/2024), 59098364 (expires 1/1/2026), 59259658 (expires 7/1/2025), and 59839687 (expires 11/1/2025). Consumers should stop using affected units and contact DeRoyal Industries for instructions on returning or replacing the product.
The recalled product
- Product
- DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06
- Manufacturer
- DeRoyal Industries Inc
- Affected units
- 384
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 (5)
- UDI/ DI 00749756917292 (each)
- 50749756917297 (case): Lot Numbers: lot 58828011 exp 11/1/2024
- lot 59098364 exp 1/1/2026
- lot 59259658 exp 7/1/2025
- lot 59839687 exp 11/1/2025
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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- Severe
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