Halyard — Class II medical device recall Z-2530-2025
Ongoing recall by AVID Medical, Inc., reported 2025-09-17, distributed nationwide. Potential for open header bag seals, compromising sterility.
| Recall number | Z-2530-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | AVID Medical, Inc., Toano, VA, United States |
| Recall initiated | 2025-08-04 |
| Classified | 2025-09-05 |
| Reported by FDA | 2025-09-17 |
| Distributed | Nationwide (US) |
| Quantity | 57 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10809160462973 |
| Lot numbers | 1647218 |
| Model numbers | JACK421-04 |
| Expiration dates | 2027-07-17 |
Product
Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit.
Reason for recall
Potential for open header bag seals, compromising sterility.
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-2530-2025. 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.