FDA Medical Device Recalls (openFDA)
SurgiSmoke Solutions: Flamingo Funnel Medium, Model Number SQ20012-02
- Recall number
- Z-1925-2026
- Recalling firm
- SurgiSmoke Solutions
- Product
- Flamingo Funnel Medium, Model Number SQ20012-02
- Status
- Open, Classified
- Initiated
- 2026-03-16
- Posted
- 2026-04-22
- Terminated
- not on file
- Reason
- Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
- 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 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
- Quantity
- 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.
- Lot, serial or model codes
- UDI-DI: 0860012888818; Lot 8264601
- 510(k) numbers
- ["K894038"]
- PMA numbers
- not on file
- Product code
- FYD
- Firm FEI
- 3008493151
- Firm city
- Saint Paul
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28