Z-0226-2026 Class III Ongoing

Recalled by Home Health US, Incorporated — Sarasota, FL

Recall Details

Product Type
Devices
Report Date
October 29, 2025
Initiation Date
July 25, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4,661 lancets

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.

Distribution Pattern

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