⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

AVID Medical, Inc.: Halyard, EP LAB PK. Catalog Number: ESJH009-03.

Medical DevicesSource: FDA (device) · Date: 2025-12-24

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
AVID Medical, Inc.
Product
Halyard, EP LAB PK. Catalog Number: ESJH009-03.
Reason / hazard
Potential for incomplete seal on header bag.
Classification
Class II
Status
Ongoing
Distribution / sold at
US distribution to GA, IL, NE, MD.
Recall initiated
2025-11-14
Code info
Catalog Number: ESJH009-03. UDI-DI: 10809160427316. Lot Code: Lot Number: 1653112. Expiration Date: 5/28/2028.
Product quantity
240 units
Voluntary mandated
Voluntary: Firm initiated
City
Toano
State
VA
Country
United States
Event id
98045
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