CLASS II ONGOING Device recall · Reported 16 Sep 2026 · FDA Enforcement Report
Halyard IV Start Kit Non-Sterile recalled by Avid Medical
Avid Medical is recalling Halyard IV Start Kit Non-Sterile, distributed nationwide in the US. The recall was initiated on 14 Jul 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3109-2026
- FDA event ID
- 99525
- Recalling firm
- Avid Medical, Toano, VA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 14 Jul 2026
- FDA classified
- 4 Sep 2026
- Reported
- 16 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 14 Jul 2026 | Recall initiated by company | |
| 4 Sep 2026 | Classified by FDA | +52 days |
| 16 Sep 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Halyard IV Start Kit Non-Sterile REF: KRIV26-02
Where it was distributed
US Nationwide distribution in the state of NE.
Questions about this recall
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.
Which lots are affected?
Lot Number:1658438 7/31/2026 UDI: 10809160460481
Where was it sold?
US Nationwide distribution in the state of NE.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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