← FDA ENFORCEMENT
Z-1338-2026Class 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
2026-02-18
Distribution
US Nationwide distribution in the states of New Jersey.
Firm state
VA
Product quantity
1,500 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Tyvek bag seal issue which may compromise sterility of the kit.

Product description

Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.

Code / lot info

Kit Code: LIFE0080-01. UDI-DI: 10809160314500. Lot Number: 1650056. Expiration Date: 07/24/2028

Other recalls SPEQ maps to Environmental Monitoring
See all Environmental Monitoring recalls →

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 →