One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 06949517008854 28g 06949517008847 23g T
Summary
The FDA issued a Class III for One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 0694951 by Home Health US, Incorporated. Reason: Due to incorrect/lack of Unique Device Identifier (UDI) codes..
Details
Source
Device Recall
External ID
Z-0226-2026
Action Date
2025-10-29
Status
Ongoing
Category
device
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.
Lot/Code Info: UDI-DI code / Size: 06949517008861 / 30g Lot Number: 2312290802 06949517008854 / 28g Lot Number: 2406310201 06949517008847 / 23g Lot Number: 2406310201
Quantity Affected: 4,661 lancets
Reason for Recall
Due to incorrect/lack of Unique Device Identifier (UDI) codes.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2025-07-25
Company
Sarasota, FL
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 308 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Home Health US, Incorporated) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Home Health US, Incorporated have FDA actions?
This is the only FDA action we have on record for Home Health US, Incorporated in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0226-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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