FDA Device recall Z-0306-2025
DeRoyal C-SECTION TRACEPACK, REF 89-9338-06
- FDA Device
- Class II
- ongoing
- Published 2024-11-13
On 2024-11-13 the FDA classified a Class II recall of DeRoyal C-SECTION TRACEPACK, REF 89-9338-06 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-0306-2025 |
| 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 C-SECTION TRACEPACK, REF 89-9338-06
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 00749756927864 (each), 50749756927869 (case): Lot Numbers: 59098305, exp 4/1/2027; 59161271, exp 3/1/2025; 59…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Deroyal Industries
- REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series
FDA Device · Class II · 2026-09-30 · Deroyal Industries - DeRoyal Industries Inc
FDA Device · Class II · 2026-06-10 · Deroyal Industries - DeRoyal REF 71-C5100NS Tubing, Suction, Connector
FDA Device · Class II · 2025-03-12 · Deroyal Industries - DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubing is intended for fluid movement
FDA Device · Class II · 2025-02-26 · Deroyal Industries - DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06
FDA Device · Class II · 2024-11-13 · Deroyal Industries
All Deroyal Industries recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0306-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.