Recall Z-0226-2026 ยท QRL Multiple Use Blood Lancet For Single Patient Use Only
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 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.
| Date | Oct 21, 2025 (initiated Jul 25, 2025) |
| Status | Open, Classified |
| Reason | Due to incorrect/lack of Unique Device Identifier (UDI) codes. |
| Root cause | Error in labeling |
| Action | 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. |
| Quantity | 4,661 lancets |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K222472 | Lancing System, Sterile Lancet for Single Use, Lancing Device Shandong Lianfa Medical Plastic Products Co. , Ltd., Nov 30, 2022 |