FDA Recall
Open, Classified
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.
Recall: Z-0226-2026
·
Initiated July 25, 2025
Recall
- Recall Number
- Z-0226-2026
- Event Number
- 97350
- Firm
- Home Health US, Incorporated
- FEI Number
- 3021186226
- Product Code
- QRL
- Status
- Open, Classified
- Root Cause
- Error in labeling
- Initiated
- July 25, 2025
- Posted
- October 21, 2025
- Address
- 7672 15th St E, Sarasota, FL, 34243-3213
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.
Reason
Due to incorrect/lack of Unique Device Identifier (UDI) codes.
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.
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
Quantity
4,661 lancets