Halyard — Class II medical device recall Z-0928-2026
Ongoing recall by AVID Medical, Inc., reported 2025-12-24, distributed in GA, IL, MD, NE. Potential for incomplete seal on header bag.
| Recall number | Z-0928-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | AVID Medical, Inc., Toano, VA, United States |
| Recall initiated | 2025-11-14 |
| Classified | 2025-12-15 |
| Reported by FDA | 2025-12-24 |
| Distributed | GA, IL, MD, NE |
| Quantity | 300 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 10809160346839 |
| Lot numbers | 1635477 |
| Model numbers | EUHM009-01 |
| Expiration dates | 2028-05-29 |
Product
Halyard, MIDTOWN GENERAL ARTERIOGRAM. Catalog Number: EUHM009-01.
Reason for recall
Potential for incomplete seal on header bag.
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-0928-2026. 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.