DeRoyal Head and Neck procedure kit — Class II medical device recall Z-0116-2024
Ongoing recall by DeRoyal Industries Inc, reported 2023-10-25, distributed in PA. DeRoyal is recalling certain lots of surgical procedure pack products that contain the B.Braun Medical Norm-Je
| Recall number | Z-0116-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | DeRoyal Industries Inc, Powell, TN, United States |
| Recall initiated | 2023-09-18 |
| Classified | 2023-10-16 |
| Reported by FDA | 2023-10-25 |
| Distributed | PA |
| Quantity | 32 kits |
| Reason classes | sterility |
| Lot numbers | 59205650, 59496207 |
| Model numbers | 89-4473 |
| Expiration dates | 2027-11-01 |
Product
DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit
Reason for recall
DeRoyal is recalling certain lots of surgical procedure pack products that contain the B.Braun Medical Norm-Ject 2 Piece Syringe. The recall is due to the potential for the sterile packaging barrier to be damaged due to damage to the luer tip of the syringe.
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-0116-2024. 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.