DeRoyal C-Section Tracepack Recall Due to Stryker Smoke Evacuation Pencil Defect
DeRoyal is recalling C-Section Tracepacks containing a Stryker SafeAir Smoke Evacuation Pencil that 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: The recall involves a medical device with a functional defect that poses a risk of harm (unintended activation) but does not meet the criteria for Severe (Class II with hospitalization) or Critical (Class I/fatalities).
Plain-English summary
DeRoyal Industries Inc is recalling 780 units of DeRoyal C-SECTION TRACEPACK, REF 89-9338-06. These surgical procedure packs contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to reports that the pencil activates without manual input when plugged into a power source or remains active after buttons are released.
The affected products were distributed nationwide in the state of Ohio. Specific lot numbers and expiration dates are listed in the agency's recall record, including lots expiring between March 2025 and April 2027.
Healthcare facilities and consumers should stop using the affected products and contact DeRoyal Industries Inc for instructions on return or replacement.
The recalled product
- Product
- DeRoyal C-SECTION TRACEPACK, REF 89-9338-06
- Manufacturer
- DeRoyal Industries Inc
- Hazard
- Affected units
- 780
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 (16)
- UDI/ DI 00749756927864 (each)
- 50749756927869 (case): Lot Numbers: 59098305
- exp 4/1/2027
- 59161271
- exp 3/1/2025
- 59245221
- exp 6/1/2025
- 59287659
- exp 5/1/2025
- 59716337
- 59866546
- exp 12/1/2025
- 59962811
- exp 11/1/2025
- 59996754
- 60104426
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.
See all 4 products in this recall →Related recalls
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