Class III — Home Health US, Incorporated
| Recalling firm | Home Health US Inc |
|---|---|
| Registered facility | HOME HEALTH US INCORPORATED (the firm's only registered facility) |
| Classification | Class III |
| Status | Ongoing |
| Reason | Due to incorrect/lack of Unique Device Identifier (UDI) codes. |
| 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. |
| Quantity | 4,661 lancets |
| Distribution | U.S.: Nation-wide distributed thru Amazon U.S. States include: AZ, CA, FL, IL, NC, NM, NY, TN, TX, and VA. O.U.S.: N/A |
| Initiated | 2025-07-25 |
| Classified | 2025-10-21 |
| Recall number | Z-0226-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Home Health US, Incorporated (Z-0226-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97350/
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