Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported November 13, 2024
DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06
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 t…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
DeRoyal Industries Inc recalled DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06 - a moderate-severity action.
DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06 was recalled by DeRoyal Industries Inc in November 13, 2024. Reason: DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Ev…. Check the official notice for the remedy. Verify recall #Z-0308-2025 with the FDA Devices before acting.
The recall
DeRoyal Industries Inc issued this moderate-severity FDA Devices recall-DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Ev….
- Moderate
- severity level
- 384 units
- affected scope
- Class II
- classification
- November 13, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0308-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0308-2025) was formally reported on November 13, 2024, with the manufacturer initiating the action on October 3, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. DeRoyal Industries Inc is listed as the recalling firm, operating out of Powell, TN. Federal records list the affected scope as 384 units.
The documented reason for this recall is: 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 i… Distribution data in the federal record shows the product reached: US Nationwide distribution in the state of OH.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
384 units
Related Recalls
6
3 from same agency
Product description
DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0308-2025 |
| Date reported | November 13, 2024 |
| Date initiated | October 3, 2024 |
| Recalling firm | DeRoyal Industries Inc |
| Firm location | Powell, TN |
| Affected scope | 384 units |
| Distribution | US Nationwide distribution in the state of OH. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0308-2025) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06. Recalled by DeRoyal Industries Inc. Units affected: 384 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 13, 2024. Severity: Moderate. Recall number: Z-0308-2025.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution in the state of OH..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0308-2025) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 13, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.