DeRoyal Surgical Procedure Pack Smoke Evacuation Pencil Recalled
DeRoyal is recalling surgical procedure pack products containing a Stryker SafeAir Smoke Evacuation Pencil that may activate without manual input or remain active after buttons are released. The malfunction poses a risk of injury during surgical procedures.
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 medical device with a malfunction that poses theoretical risk of injury (unintended activation during surgery), with no reported injuries or hospitalizations. Meets the High criterion: risk-of-harm products where injury has not yet been reported.
Plain-English summary
DeRoyal Industries Inc is recalling certain lots of surgical procedure pack products containing a Stryker SafeAir Smoke Evacuation Pencil, model 89-9362.06. A total of 95 units are affected by this recall.
The recall is due to reports that the pencil may activate without manual input when plugged into a power source, or may remain active after buttons are released. This unintended activation could pose a risk of injury during surgical use.
The recalled products were distributed nationwide in Ohio. The affected lot number is 59244907 with an expiration date of October 1, 2025. The devices are identified by UDI/DI 00749756913393 (each unit) or 50749756913398 (case).
The recalled product
- Product
- DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06
- Manufacturer
- DeRoyal Industries Inc
- Affected units
- 95
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 00749756913393 (each)
- 50749756913398 (case): Lot Numbers: lot 59244907 exp 10/1/2025
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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