FDA Medical devices recall ·
Halyard IV Start Kit Non-Sterile recall
- Recall number
- Z-3109-2026
- Date
- (initiated July 14, 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
- 98 Kits
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Halyard IV Start Kit Non-Sterile REF: KRIV26-02
Why was it recalled?
Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which lacks sterility assurance due to to wrinkles in the paper lidding which may breach the seal area.
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
Lot Number:1658438 7/31/2026 UDI: 10809160460481
Distribution
US Nationwide distribution in the state of NE.
States: Nebraska
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-3109-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.