RecallDepth

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.

Company
Home Health Us, Incorporated
Recall Initiated
July 25, 2025
Posted
October 21, 2025
Recall Number
Z-0226-2026
Quantity
4,661 lancets
Firm Location
Sarasota, FL

Reason for Recall

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

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

Lot / Code Info

UDI-DI code / Size: 06949517008861 / 30g Lot Number: 2312290802 06949517008854 / 28g Lot Number: 2406310201 06949517008847 / 23g Lot Number: 2406310201

Root Cause

Error in labeling

Action Taken

On 07/25/2025, the firm indicated that they notified Amazon of the recall (mis-labeling) and Amazon has returned affected products that Amazon had in their possession.