FDA recall Z-1925-2026

Product

Flamingo Funnel Medium, Model Number SQ20012-02

Reason for recall

Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.

Distribution

Worldwide - US Nationwide distribution in the states of CA, CO, GA, MA, MD, ME, MN, NH, NY, OH, TN, TX, and UT. The country of Canada.

Key facts

Status

Ongoing

Initiation date

2026-03-16

Report date

2026-04-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Saint Paul, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1925-2026