The Recall Desk
HighFDA (Devices)·Z-0306-2025·Announced 2024-11-13

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.

What this means for you

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
Category
Medical Device — Surgical Instruments
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

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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

Same manufacturer · DeRoyal Industries Inc

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Same hazard · unintended activation

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