SurgiSmoke Solutions recalls Flamingo Funnel Large

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

Flamingo Funnel Large, Model Number SQ20012-03

An URGENT: MEDICAL DEVICE RECALL notification letter was sent to customers beginning 3/16/26. Actions to be taken by the Customer/End User: 1. Immediately discontinue use of this product. Note: The lots listed in this notice are the only lots impacted. All subsequently built product contains a correct, gamma compatible drape. 2. Dispose of impacted product according to local and national waste disposal procedures. Note: ALL PRODUCT MUST BE ACCOUNTED FOR ON THE MEDICAL DEVICE RECALL RETURN RESPONSE ACKNOWLEDGEMENT AND RECEIPT FORM. 3. Acknowledge receipt of this notice. Complete and return the attached Medical Device Recall Return Response Acknowledgement and Receipt Form via phone, US Mail, or email even if you no longer have any affected product in inventory: Phone: Communicate the information required in the attached form by calling the toll free number: 1-800-557-3698 - available M-F between 8:00AM and 6:00PM CST US Mail: Complete the attached form, and mail it back using the enclosed self-addressed, stamped envelope (if notice received by mail) Email: Complete the attached form and return it to quality@surgismokesolutions.com Please forward this notification to any additional customers to whom the affected product may have been distributed. Type of Action by the Company: In addition to this Recall activity, Nascent Surgical has initiated Corrective Action and Preventive Action measures that include but are not limited to: Correcting the Bill of Materials to include a gamma compatible drape (completed Jan 2025) Changing the packaging configuration to remove the fold (completed Jan 2025) Improving Quality System Planning and other procedures to prevent recurrence Other Information: If you have additional questions about this notice, please contact us: By phone 1-800-557-3698 (toll free) - available M-F between 8:00AM and 6:00PM CST By emailing quality@surgismokesolutions.com

• FDA enforcement recordOfficial FDA database entry for Z-1926-2026
• FDA 510(k) clearance · K894038The device's official FDA premarket clearance record
• FDA device classification · FYDOfficial FDA classification for this device type
• CFR regulation · 21 CFR 878.5070The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find SurgiSmoke SolutionsSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.