Flamingo Funnel Medical Device Recall - Sterility Loss Risk
Summary
Health Canada issued a Type II recall for Flamingo Funnel™ medical devices (lots 8264501, 8264601, 8264701, model SQ-20012-01) manufactured by Nascent Surgical D/B/A SurgiSmoke Solutions. The recall was initiated due to a packaging defect where a non-gamma-compatible drape degraded under heat, causing pinholes and potential loss of sterility. Healthcare providers must immediately stop using affected lots and dispose per national and local regulations.
What changed
Health Canada has issued a Type II medical device recall (ID RA-81823) for the Flamingo Funnel™ smoke evacuation device. The recall affects three lot numbers (8264501, 8264601, 8264701) of catalog number SQ-20012-01. The root cause is a packaging defect: the non-gamma-compatible drape degraded under heat during processing, creating pinholes that compromise the sterility barrier. The US-based manufacturer is Nascent Surgical D/B/A SurgiSmoke Solutions, St. Paul, Minnesota.
Healthcare providers and facilities with any units from these lots must immediately cease use, quarantine the products, and dispose of them in accordance with applicable national and local regulations for medical device waste. Customers will be contacted directly with specific disposal instructions. The recall is categorized as Type II (moderate risk), meaning temporary adverse health consequences are possible if the compromised device is used in sterile procedures.
What to do next
- Immediately stop using all Flamingo Funnel™ units from lots 8264501, 8264601, and 8264701
- Quarantine affected inventory and await customer contact for return/disposal instructions
- Dispose of affected devices per applicable national and local medical device waste regulations
Archived snapshot
Apr 2, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Health product recall
Flamingo Funnel™
Brand(s)
Nascent Surgical D/B/A SurgiSmoke Solutions
Last updated
2026-04-01
Summary
Product Flamingo Funnel™ Issue Medical devices - Sterility What to do Customers will be contacted with instructions to follow.
Audience Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Flamingo Funnel™ | 8264501 | SQ-20012-01 |
| Flamingo Funnel™ | 8264601 | SQ-20012-01 |
| Flamingo Funnel™ | 8264701 | SQ-20012-01 |
Issue
Packaging defect: A non-gamma-compatible drape degraded under heat, causing pinholes and possible loss of sterility. Users should immediately stop using affected lots, dispose of them per national and local regulations.
Additional information
Details
Original published date:
2026-04-01
Alert / recall type Health product recall Category Health products - Medical devices - General hospital and personal use Companies Nascent Surgical D/B/A SurgiSmoke Solutions
2300 Myrtle Ave, Suite 200, St. Paul, Minnesota, United States, 55114
Published by Health Canada Audience Healthcare Recall class Type II Recall date
2026-03-16
Identification number RA-81823
Get notified
Receive emails about new and updated recall and safety alerts.
Related changes
Get daily alerts for Health Canada Recalls & Safety Alerts
Daily digest delivered to your inbox.
Free. Unsubscribe anytime.
Source
About this page
Every important government, regulator, and court update from around the world. One place. Real-time. Free. Our mission
Source document text, dates, docket IDs, and authority are extracted directly from HC.
The summary, classification, recommended actions, deadlines, and penalty information are AI-generated from the original text and may contain errors. Always verify against the source document.
Classification
Who this affects
Taxonomy
Browse Categories
Get alerts for this source
We'll email you when Health Canada Recalls & Safety Alerts publishes new changes.
Subscribed!
Optional. Filters your digest to exactly the updates that matter to you.