Medical device recalls

Home Health US, Incorporated recalls One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 06949517008854 28g 06949517008847 23g The Lancing…

Recall date
July 25, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0226-2026
FDA classification
Class III
Brand / firm
Home Health US, Incorporated
Sold / distributed
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

Why it was recalled

Due to incorrect/lack of Unique Device Identifier (UDI) codes.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.

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