Flamingo Funnel Large, Model Number SQ20012-03

FDA device recall Z-1926-2026 · posted 2026-04-22 · Open, Classified

Recall details

Recalling firm

SurgiSmoke Solutions

Reason for recall

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

Action taken

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

Root cause

Packaging change control

Status

Open, Classified

Product code

FYD

Quantity affected

2505 units total

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.

Date initiated

2026-03-16

Date posted

2026-04-22

Location

Saint Paul, MN

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