FDA recall Z-0226-2026

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 as the palm, the upper arm, and the forearm.

Reason for recall

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

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

Key facts

Status

Ongoing

Initiation date

2025-07-25

Report date

2025-10-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sarasota, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0226-2026