Home Health US recalled 4,661 sterile lancets on July 25, 2025. The recall stems from incorrect or missing Unique Device Identifier (UDI) codes. Affected products were distributed nationwide through Amazon.
Due to incorrect/lack of Unique Device Identifier (UDI) codes.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Home Health US, Incorporated or your healthcare provider for instructions. Notification method: Letter
The recall includes sterile lancets in three sizes: 30g (UDI: 06949517008861), 28g (UDI: 06949517008854), and 23g (UDI: 06949517008847). These products were distributed across multiple states including Arizona, California, Florida, Illinois, North Carolina, New Mexico, New York, Tennessee, Texas, and Virginia.
The absence of proper UDI codes can lead to misidentification of the device. This increases the risk of improper use, which could compromise patient safety.
No specific incidents or injuries have been reported related to this recall. The potential for harm exists due to the improper identification of the product.
Stop using the affected lancets immediately. Patients should contact Home Health US or their healthcare provider for instructions on how to return the product.
For more information, contact Home Health US, Incorporated. Visit the recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0226-2026.
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