FDA Device recall Z-3194-2026
Halyard IV START KIT NON-STERILE
- FDA Device
- Class I
- ongoing
- Published 2026-09-30
On 2026-09-30 the FDA classified a Class I recall of Halyard IV START KIT NON-STERILE by Avid Medical, citing convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may be contaminated with Aspergillus penicillioides.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3194-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2026-07-22 |
| Published | 2026-09-30 |
| Last updated | 2026-10-06 05:30 UTC |
| Company | Avid Medical |
| Distribution | US |
Product
Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-02.
Reason
Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may be contaminated with Aspergillus penicillioides.
Identifiers
| code_info | Kit Model Number: KRIV26-02. UDI-DI: 10809160460481. Lot Number: 1658437. Expiration Date: 1/31/2027 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-06 05:30 UTC. Current status: ongoing.
Other recalls by 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 - Halyard IV START KIT NON-STERILE REF: KRIV26-02
FDA Device · Class I · 2026-09-23 · Avid Medical
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3194-2026%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.