Class III

Medical Device Recall: 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

Home Health US, Incorporated · July 25, 2025

Reason for Recall

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

Product Description

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.

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

States Affected

AZ, CA, FL, IL, NC, NM, NY, TN, TX, VA

Quantity Affected

4,661 lancets

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0226-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Home Health US, Incorporated Medical Device Recall: 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 | SafeCheck