Notice names this product. SurgiSmoke Solutions’s Flamingo Funnel Medium is named in FDA Class II recall Z-1925-2026.
Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies.Agency-reported hazard: Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape. Identifying details: UDI-DI: 0860012888818; Lot 8264601. Units affected: 2505 units total. Status: Ongoing.
1. Compare your item
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Product named
Flamingo Funnel Medium
Company / brand
SurgiSmoke Solutions
Lot / serial / date codes
UDI-DI: 0860012888818; Lot 8264601
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.
Agency product description and boundaries
Flamingo Funnel Medium, Model Number SQ20012-02
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.