FDAHealthJuly 25, 2025
Home Health US, Incorporated — One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 06949517008854 28g 06949517008847 23g The Lancing System is intended for the hygienic co
⚠️ Due to incorrect/lack of Unique Device Identifier (UDI) codes.
Is this relevant to me?
- Geography
- AZ, CA, FL, IL, NC, NM, NY, TN, TX, VA
- Source agency
- FDA
- Category
- Health
- Published
- July 25, 2025
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
What's affected?
- 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.
- Lot code
- 2312290802
Additional details
UDI-DI code / Size: 06949517008861 / 30g Lot Number: 2312290802 06949517008854 / 28g Lot Number: 2406310201 06949517008847 / 23g Lot Number: 2406310201
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 4,661 lancets.
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