← FDA ENFORCEMENT
Z-0929-2026Class II
AVID Medical, Inc.
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
AVID Medical, Inc.
Product type
Device
Status
Ongoing
Report date
2025-12-24
Distribution
US distribution to GA, IL, NE, MD.
Firm state
VA
Product quantity
90 units
Initiated by
Voluntary: Firm initiated
Reason for recall
Potential for incomplete seal on header bag.
Product description
Halyard, MAJOR PACK. Catalog Number: JEMJ10-01.
Code / lot info
Catalog Number: JEMJ10-01. UDI-DI: 10809160443217. Lot Number: 1635770. Expiration Date: 7/26/2027.
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →