Recall
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.
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.

View original FDA notice →

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