DeRoyal C-SECTION TRACEPACK — Class II medical device recall Z-0306-2025
Ongoing recall by DeRoyal Industries Inc, reported 2024-11-13, distributed nationwide. DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Eva
| Recall number | Z-0306-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | DeRoyal Industries Inc, Powell, TN, United States |
| Recall initiated | 2024-10-03 |
| Classified | 2024-11-05 |
| Reported by FDA | 2024-11-13 |
| Distributed | Nationwide (US) |
| Quantity | 780 units |
| UPC / GTIN / UDI-DI | 00749756927864, 50749756927869 |
| Lot numbers | 59098305, 59161271, 59245221, 59287659, 59716337, 59866546, 59962811, 59996754, 60104426 |
| Model numbers | 89-9338-06 |
| Expiration dates | 2025-03-01, 2025-05-01, 2025-06-01, 2025-11-01, 2025-12-01, 2027-04-01 |
Product
DeRoyal C-SECTION TRACEPACK, REF 89-9338-06
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0306-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.