FDA Medical devices recall ·
Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01 recall
- Recall number
- Z-1338-2026
- Date
- (initiated January 2, 2026)
- Company / brand
- AVID Medical, Inc.
9000 Westmont Dr, Toano, VA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1,500 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.
Why was it recalled?
Tyvek bag seal issue which may compromise sterility of the kit.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Kit Code: LIFE0080-01. UDI-DI: 10809160314500. Lot Number: 1650056. Expiration Date: 07/24/2028
Distribution
US Nationwide distribution in the states of New Jersey.
States: New Jersey
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1338-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.