FDA Device recall Z-0309-2025
DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06
- FDA Device
- Class II
- ongoing
- Published 2024-11-13
On 2024-11-13 the FDA classified a Class II recall of DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06 by Deroyal Industries, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0309-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-03 |
| Published | 2024-11-13 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Deroyal Industries |
| Distribution | US |
Product
DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06
Reason
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.
Identifiers
| code_info | UDI/ DI 00749756913393 (each), 50749756913398 (case): Lot Numbers: lot 59244907 exp 10/1/2025 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0309-2025%22
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