Recall Z-0226-2026— Home Health US, Incorporated

Name: FDA recall Z-0226-2026
Creator: U.S. Food and Drug Administration
Published: 2025-07-25

Class III · Ongoing

Class III FDA medical device recall by Home Health US, Incorporated, initiated 2025-07-25. It names one FDA 510(k) clearance: K222472. Product: 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: Due to incorrect/lack of Unique Device Identifier (UDI) codes..

Recalling firm: Home Health US, Incorporated
Classification: Class III
Status: Ongoing
Initiated: 2025-07-25
Firm location: Sarasota, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K222472 — Lancing System, Sterile Lancet for Single Use, Lancing DeviceShandong Lianfa Medical Plastic Products Co. , Ltd.·cleared 2022-11-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.