FDAHealthNovember 14, 2025
AVID Medical, Inc. — Halyard, EP LAB PK. Catalog Number: ESJH009-03.
⚠️ Potential for incomplete seal on header bag.
Is this relevant to me?
- Geography
- US, GA, IL, NE, MD
- Source agency
- FDA
- Category
- Health
- Published
- November 14, 2025
US distribution to GA, IL, NE, MD.
What's affected?
- Product
- Halyard, EP LAB PK. Catalog Number: ESJH009-03.
- Brand
- AVID Medical, Inc.
- Lot code
- Lot
Additional details
Catalog Number: ESJH009-03. UDI-DI: 10809160427316. Lot Code: Lot Number: 1653112. Expiration Date: 5/28/2028.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 240 units.
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