Use caution Medical device recall · FDA · Published October 3, 2024

DeRoyal Children's Laptracepack Recall: Smoke Evacuation Pencil Activates Without Input

DeRoyal is recalling certain Children's Laptracepack surgical packs due to a Stryker SafeAir Smoke Evacuation Pencil activating without manual input when plugged in or remaining active after button release.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0309-2025Medical device DeRoyal ›

Use caution until it’s fixed

DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged into a power source or remains active after buttons are released.

Take action

Contact the company

Recalling firmDeRoyal Industries Inc200 Debusk Ln · Powell, TN 37849-4703

✎ GovInfoNow plain-language explainer

DeRoyal is recalling specific lots of Children's Laptracepack surgical packs because a Stryker SafeAir Smoke Evacuation Pencil inside can activate without manual input or stay active after buttons are released. This could lead to unintended smoke evacuation in medical settings. Read more at govinfonow.com/recall/53819-deroyal-children-s-laptracepack-recall-smoke-evacuation-pencil-activates-without.

Source Summary by GovInfoNow · govinfonow.com/recall/53819-deroyal-children-s-laptracepack-recall-smoke-evacuation-pencil-activates-without · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0309-2025

Cite this page

“DeRoyal Children's Laptracepack Recall: Smoke Evacuation Pencil Activates Without Input.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53819-deroyal-children-s-laptracepack-recall-smoke-evacuation-pencil-activates-without. Based on FDA recall #Z-0309-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0309-2025%22&limit=1).

DeRoyal Industries Inc recalled DeRoyal CHILDREN'S LAPTRACEPACK, model 89-9362.06, due to a Stryker SafeAir Smoke Evacuation Pencil activating without manual input or remaining active after use, according to the FDA on Oct. 3, 2024.

How to tell if you have it

Brand: DeRoyal
Product: CHILDREN'S LAPTRACEPACK
Model: 89-9362.06
Lot: 59244907 exp 10/1/2025
UDI/DI (each): 00749756913393
UDI/DI (case): 50749756913398
Distribution: US Nationwide, state of OH
Units: 95

The hazard

The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged into a power source or remains active after buttons are released.

Context

GovInfoNow's records show DeRoyal Industries Inc has 29 other recalls on record since 2017-06-07. Other recent recalls of similar products include Stryker NICO BrainPath Shephard's Hook Recall (2025-10-31) and Medline Medical Kits Recall (2026-03-24).

How to tell if you have this one

Check for the lot number 59244907 with expiration date 10/1/2025 on the DeRoyal Children's Laptracepack surgical packs. The product is sold in cases with UDI/DI numbers 00749756913393 (each) and 50749756913398 (case).

Brand
DeRoyal
Category
Medical device

FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
US Nationwide distribution in the state of OH.

Recall number	Product, codes & lots	Quantity
Z-0306-2025	DeRoyal C-SECTION TRACEPACK, REF 89-9338-06; 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, exp 5/1/2025;59866546, exp 12/1/2025; 59962811, exp 11/1/2025; 59996754, exp 12/1/2025; 60104426, exp 11/1/2025	780 units
Z-0307-2025	DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06; UDI/ DI 00749756916646 (each), 50749756916641 (case): Lot Numbers: lot 59839716 exp 12/1/2025	160 units
Z-0308-2025	DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06; 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	384 units
Z-0309-2025	DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06; UDI/ DI 00749756913393 (each), 50749756913398 (case): Lot Numbers: lot 59244907 exp 10/1/2025	95 units

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the lot number 59244907 with expiration date 10/1/2025 on the DeRoyal Children's Laptracepack surgical packs.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide distribution in the state of OH.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 41 days after the firm started it.

Oct 3, 2024Firm started the recall
Nov 5, 2024FDA classified it Class II
Nov 13, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/53819-deroyal-children-s-laptracepack-recall-smoke-evacuation-pencil-activates-without">DeRoyal Children's Laptracepack Recall: Smoke Evacuation Pencil Activates Without Input (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0309-2025 (October 3, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0309-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.