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-3108-2026
- Date
- (initiated July 14, 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 units
- Hazard tags
- Microbial contamination
- 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 are 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
Lot Number: 1658437 UDI: 10809160460481
Distribution
US Nationwide distribution in the state of NE.
States: Nebraska
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-3108-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.