FDA Device recall Z-3109-2026
Halyard IV Start Kit Non-Sterile REF: KRIV26-02
- FDA Device
- Class II
- ongoing
- Published 2026-09-16
On 2026-09-16 the FDA classified a Class II recall of Halyard IV Start Kit Non-Sterile REF: KRIV26-02 by Avid Medical, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3109-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-14 |
| Published | 2026-09-16 |
| Last updated | 2026-09-23 05:30 UTC |
| Company | Avid Medical |
| Distribution | US |
Product
Halyard IV Start Kit Non-Sterile REF: KRIV26-02
Reason
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.
Identifiers
| code_info | Lot Number:1658438 7/31/2026 UDI: 10809160460481 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-23 05:30 UTC. Current status: ongoing.
Other recalls by Avid Medical
- Halyard IV START KIT NON-STERILE
FDA Device · Class I · 2026-09-30 · Avid Medical - Halyard IV START KIT NON-STERILE
FDA Device · Class II · 2026-09-30 · Avid Medical - Halyard IV START KIT NON-STERILE
FDA Device · Class II · 2026-09-30 · Avid Medical - Haylard CONTINUOUS NERVE BLOCK TRAY
FDA Device · Class I · 2026-09-23 · Avid Medical - Haylard 18G SINGLE SHOT EPI TRAY
FDA Device · Class I · 2026-09-23 · Avid Medical
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3109-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.