Home Health US, Incorporated has recalled 4,661 One Step Sterile Lancets for Single Use because the products were distributed with incorrect or missing Unique Device Identifier (UDI) codes on the packaging. These lancets, sold in 23g, 28g, and 30g sizes, are used by consumers and healthcare providers to collect blood samples from fingertips and other body sites. The company initiated the recall after discovering the labeling error, which affects products distributed nationwide through Amazon.
Missing or incorrect UDI codes prevent the accurate tracking and identification of medical devices throughout the healthcare system, which is critical for monitoring safety and performance. While there are no reported injuries, incorrect labeling could lead to confusion or difficulty identifying specific units in the event of a future safety issue.
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Intended for hygienic collection of capillary blood.
Intended for hygienic collection of capillary blood.
Intended for hygienic collection of capillary blood.
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Sources: FDA iRES · Raw API Response
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