CLASS II ONGOING Device recall · Reported 13 Nov 2024 · FDA Enforcement Report
DeRoyal Children's Laptracepack recalled by DeRoyal Industries
DeRoyal Industries is recalling DeRoyal Children's Laptracepack, 89-9362.06, distributed nationwide in the US. The recall was initiated on 3 Oct 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0309-2025
- FDA event ID
- 95509
- Recalling firm
- DeRoyal Industries, Powell, TN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Oct 2024
- FDA classified
- 5 Nov 2024
- Reported
- 13 Nov 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 3 Oct 2024 | Recall initiated by company | |
| 5 Nov 2024 | Classified by FDA | +33 days |
| 13 Nov 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06
Where it was distributed
US Nationwide distribution in the state of OH.
Questions about this recall
Why was it 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 lots are affected?
UDI/ DI 00749756913393 (each), 50749756913398 (case): Lot Numbers: lot 59244907 exp 10/1/2025
Where was it sold?
US Nationwide distribution in the state of OH.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 95509| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | DeRoyal Children's Orthopedic Tracepack recalled by DeRoyal Industries | DeRoyal Industries | Other | Nationwide | |
| CLASS II | DeRoyal Children's General Tracepack recalled by DeRoyal Industries | DeRoyal Industries | Other | Nationwide | |
| CLASS II | DeRoyal C-section Tracepack recalled by DeRoyal Industries | DeRoyal Industries | Other | Nationwide |
More recalls from DeRoyal Industries
All 227| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series recalled | DeRoyal Industries | Temperature Abuse | Nationwide |
| Device | CLASS II | DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access recalled | DeRoyal Industries | Sterility | Nationwide |
| Device | CLASS II | DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF recalled | DeRoyal Industries | Foreign Material | 5 states |
| Device | CLASS II | DeRoyal AMG Suction Connector Tubing recalled by DeRoyal Industries | DeRoyal Industries | Packaging Defects | 21 states |
| Device | CLASS II | DeRoyal C-section Tracepack recalled by DeRoyal Industries | DeRoyal Industries | Other | Nationwide |
Other Other Medical Devices recalls
All 13,857| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: Major Pack recalled by Medline Industries | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Peds Sinus Pack recalled by Medline Industries | Medline Industries | Other | Nationwide |
| Device | CLASS II | SmartPath to dStream for XR and 3.0T recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Achieva 1.5T, Achieva 1.5T Conversion recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Mfc Craniotomy Pack recalled | Medline Industries | Other | Nationwide |