One Step Sterile Lancet for Single Use — Class III medical device recall Z-0226-2026
Ongoing recall by Home Health US, Incorporated, reported 2025-10-29, distributed nationwide. Due to incorrect/lack of Unique Device Identifier (UDI) codes.
| Recall number | Z-0226-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Home Health US, Incorporated, Sarasota, FL, United States |
| Recall initiated | 2025-07-25 |
| Classified | 2025-10-21 |
| Reported by FDA | 2025-10-29 |
| Distributed | Nationwide (US) |
| Quantity | 4,661 lancets |
| UPC / GTIN / UDI-DI | 06949517008847, 06949517008854, 06949517008861 |
| Lot numbers | 2312290802, 2406310201 |
Product
One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 06949517008854 28g 06949517008847 23g The Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm.
Reason for recall
Due to incorrect/lack of Unique Device Identifier (UDI) codes.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0226-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.