Halyard IV Start Kit Non-Sterile REF: KRIV26-02 recall (AVID Medical, Inc.)
Medical deviceClass IIOngoing
Summary: AVID Medical, Inc. is recalling 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.
What is being recalled
Halyard IV Start Kit Non-Sterile REF: KRIV26-02
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the state of NE. (states named: Nebraska)
How to tell if yours is affected
Lot Number:1658438 7/31/2026 UDI: 10809160460481
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-3109-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | July 14, 2026 |
| Reported | September 16, 2026 |
| Company | AVID Medical, Inc. |
| Company location | Toano, VA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 98 Kits |
More recalls from AVID Medical, Inc. · all medical device recalls · recalls from July 2026