FDA Medical devices recall ·
Halyard IV START KIT NON-STERILE recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-3194-2026
- Date
- (initiated July 22, 2026)
- Company / brand
- AVID Medical, Inc.
9000 Westmont Dr, Toano, VA, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 288 kits (6 cases)
- Hazard tags
- Microbial contamination
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-02.
Why was it recalled?
Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may be contaminated with Aspergillus penicillioides.
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 Model Number: KRIV26-02. UDI-DI: 10809160460481. Lot Number: 1658437. Expiration Date: 1/31/2027
Distribution
US Nationwide distribution.
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-3194-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.