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.
FDA Recall Z-0226-2026 · Posted 2025-10-21
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Recalling FirmHome Health US, Incorporated
Recall StatusOpen, Classified
Product CodeQRL
Date Initiated2025-07-25
Product Quantity4,661 lancets
Reason for Recall
Due to incorrect/lack of Unique Device Identifier (UDI) codes.
Firm 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.
Root Cause
Error in labeling
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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