Flamingo Funnel Medical Device Recall - Sterility Loss Risk

Health Canada Recalls & Safety Alerts

Filed March 16th, 2026

Detected April 2nd, 2026

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.

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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

Source document (simplified)

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