Z-1926-2026Class II

Flamingo Funnel Large, Model Number SQ20012-03

Name: Z-1926-2026 Flamingo Funnel Large, Model Number SQ20012-03
Creator: SurgiSmoke Solutions
Published: 2026-03-16
License: https://open.fda.gov/license/

SurgiSmoke Solutions / initiated 2026-03-16 / Open, Classified / root cause: packaging

FDA source

SurgiSmoke Solutions began a recall of Flamingo Funnel Large, Model Number SQ20012-03 on 2026-03-16. FDA classified it as Class II and gives the reason as "Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1926-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-16
Posted: 2026-04-22
Recalling firm: SurgiSmoke Solutions
Product: Flamingo Funnel Large, Model Number SQ20012-03
Product code: FYD Apparatus, Exhaust, Surgical
Reason for recall: Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
Root cause tag: packaging
FDA root cause: Packaging change control
Action: 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 [email protected] 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 [email protected]
Quantity in commerce: 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.
Product codes and lots: UDI-DI: 408882777851966; Lot 8264501

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1926-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1924-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-22
Z-1925-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-22
Z-1926-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-22

Product code FYD

K894038Class IIPlume-Away Smoke Evacuation SystemLaser Technologies Group, Inc. / cleared 1989-09-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)