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.
This recall is currently active, issued October 21, 2025. It was issued by Home Health Us, Incorporated.
- Company
- Home Health Us, Incorporated
- Recall Initiated
- July 25, 2025
- Posted
- October 21, 2025
- Recall Number
- Z-0226-2026
- Quantity
- 4,661 lancets
- Firm Location
- Sarasota, FL
- Official Source
- View on FDA website ↗
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
Lot / Code Info
UDI-DI code / Size: 06949517008861 / 30g Lot Number: 2312290802 06949517008854 / 28g Lot Number: 2406310201 06949517008847 / 23g Lot Number: 2406310201
Root Cause
Error in labeling
Action Taken
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.