Lancet Recall: Home Health US One Step Sterile
Announced 2025-10-29 · FDA
The FDA is recalling Home Health US's One Step Sterile Lancet for Single Use (three sizes) due to incorrect or missing Unique Device Identifier (UDI) codes. About 4,661 lancets were distributed nationwide through Amazon. The recall notice does not specify any corrective action.
| Brand | Home Health US, Incorporated |
|---|---|
| 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. |
| Severity | low |
| Units affected | 4661 |
| 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 |
| Agency | FDA |
| Recall / campaign no. | UDI-DI code / Size: 06949517008861 / 30g Lot Number: 2312290802 06949517008854 / 28g Lot Number: 2406310201 06949517008847 / 23g Lot Number: 2406310201 |
WHAT YOU SHOULD DO
- Check if your lancets match the listed UDI/size and lot numbers (06949517008861 / 30g – Lot 2312290802; 06949517008854 / 28g – Lot 2406310201; 06949517008847 / 23g – Lot 2406310201).
- If they match, stop using them and set them aside.
- Contact Home Health US for instructions on return, replacement, or disposal and to obtain any remedies.
- If you have health concerns, consult your healthcare provider.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.