One Step Sterile Lancet for Single Use (3 sizes) recallZ-0226-2026 · Home Health US, Incorporated · initiated Jul 25, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Home Health US, Incorporated or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to incorrect/lack of Unique Device Identifier (UDI) codes.
FDA root cause category: Error in labeling
What the company is doing
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.
Recall details
- Recall number
- Z-0226-2026
- Status
- Open, Classified
- Initiated by the company
- Jul 25, 2025
- Posted by the FDA
- Oct 21, 2025
- Recalling firm
- Home Health US, Incorporated
- Quantity
- 4,661 lancets
- Product code
- QRL
- FDA submissions
- K222472
- 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
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.
Code information (models, lots, serial numbers)
UDI-DI code / Size: 06949517008861 / 30g Lot Number: 2312290802 06949517008854 / 28g Lot Number: 2406310201 06949517008847 / 23g Lot Number: 2406310201
Devices named in this recall
3 devices in the FDA device registry whose identifier appears in the recall's code information.
- One +Step LF-TL-23-IShandong Lianfa Medical Plastic Products CO.,LTD · Multiple Use Blood Lancet For Single Patient Use Only1 recall0 reports
- One +Step LF-TL-28-IShandong Lianfa Medical Plastic Products CO.,LTD · Multiple Use Blood Lancet For Single Patient Use Only1 recall0 reports
- One +Step LF-TL-30-IIShandong Lianfa Medical Plastic Products CO.,LTD · Multiple Use Blood Lancet For Single Patient Use Only1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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