Recall Z-1924-2026— SurgiSmoke Solutions

Name: FDA recall Z-1924-2026
Creator: U.S. Food and Drug Administration
Published: 2026-03-16

Class II · Ongoing

Class II FDA medical device recall by SurgiSmoke Solutions, initiated 2026-03-16. It names one FDA 510(k) clearance: K894038. Product: Flamingo Funnel Small, Model Number SQ20012-01. Reason: Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape..

Recalling firm: SurgiSmoke Solutions
Classification: Class II
Status: Ongoing
Initiated: 2026-03-16
Firm location: Saint Paul, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K894038 — PLUME-AWAY SMOKE EVACUATION SYSTEMLaser Technologies Group, Inc.·cleared 1989-09-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Flamingo Funnel Small, Model Number SQ20012-01

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.