One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 06949517008854 28g 06949517008847 23g The Lancing S
FDA device recall Z-0226-2026 · posted 2025-10-21 · Open, Classified
Recall details
- Recalling firm
- Home Health US, Incorporated
- Reason for recall
- Due to incorrect/lack of Unique Device Identifier (UDI) codes.
- 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.
- Root cause
- Error in labeling
- Status
- Open, Classified
- Product code
- QRL
- Quantity affected
- 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
- Date initiated
- 2025-07-25
- Date posted
- 2025-10-21
- Location
- Sarasota, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Lancing System, Sterile Lancet for Single Use, Lancing Device (K222472) | Shandong Lianfa Medical Plastic Products Co. , Ltd. | 2022-11-30 |