The Recall Desk
HighFDA (Devices)·Z-0226-2026·Announced 2025-10-29

[pending] One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 06949517008854 28g 06949

Pending LLM rewrite. Source: FDA_DEVICE Z-0226-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

Due to incorrect/lack of Unique Device Identifier (UDI) codes.

The recalled product

Product
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
Manufacturer
Home Health US, Incorporated

Distribution

Distributed in 10 states:

  • AZ
  • CA
  • FL
  • IL
  • NC
  • NM
  • NY
  • TN
  • TX
  • VA