One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 06949517008854 28g 06...
FDA Recall #Z-0226-2026 — Class III — July 25, 2025
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.
Reason for Recall
Due to incorrect/lack of Unique Device Identifier (UDI) codes.
Recalling Firm
Home Health US, Incorporated — Sarasota, FL
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Devices
Product 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
Code Information
UDI-DI code / Size: 06949517008861 / 30g Lot Number: 2312290802 06949517008854 / 28g Lot Number: 2406310201 06949517008847 / 23g Lot Number: 2406310201
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated