FDA Medical devices recall ·
One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g… recall
- Recall number
- Z-0226-2026
- Date
- (initiated July 25, 2025)
- Company / brand
- Home Health US, Incorporated
7672 15th St E, Sarasota, FL, United States - Category
- Medical devices › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 4,661 lancets
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Due to incorrect/lack of Unique Device Identifier (UDI) codes.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI code / Size: 06949517008861 / 30g Lot Number: 2312290802 06949517008854 / 28g Lot Number: 2406310201 06949517008847 / 23g Lot Number: 2406310201
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
States: Arizona California Florida Illinois North Carolina New Mexico New York Tennessee Texas Virginia
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (medical devices), recall Z-0226-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.