FDA Device recall Z-0226-2026
One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 06949517008854 28g 06949517008847 23g The Lancing System is intended f…
- FDA Device
- Class III
- ongoing
- Published 2025-10-29
On 2025-10-29 the FDA classified a Class III recall of One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 06949517008854 28g 06949517008847 23g The Lancing System is intended f… by Home Health Us, citing due to incorrect/lack of Unique Device Identifier (UDI) codes.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0226-2026 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2025-07-25 |
| Published | 2025-10-29 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Home Health Us |
| Distribution | AZ, CA, FL, IL, NC, NM, NY, TN, TX, VA |
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
Due to incorrect/lack of Unique Device Identifier (UDI) codes.
Identifiers
| code_info | UDI-DI code / Size: 06949517008861 / 30g Lot Number: 2312290802 06949517008854 / 28g Lot Number: 2406310201 06949517008847 / 23g Lot Number: 2406310201 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0226-2026%22
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