Flamingo Funnel Large surgical smoke evacuation device recall
SurgiSmoke Solutions is recalling certain lots of the Flamingo Funnel Large (Model SQ20012-03) surgical device due to a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a manufacturing nonconformance with sterilization compatibility, which presents a potential risk but is classified as moderate because the source states no adverse health consequences have been documented.
Plain-English summary
SurgiSmoke Solutions is recalling certain lots of the Flamingo Funnel Large, Model Number SQ20012-03, a surgical smoke evacuation device. The recall is due to a manufacturing nonconformance involving the use of a non-gamma sterilization compatible drape.
The affected product (UDI-DI: 408882777851966; Lot 8264501) was distributed worldwide and within the United States in California, Colorado, Georgia, Massachusetts, Maryland, Maine, Minnesota, New Hampshire, New York, Ohio, Tennessee, Texas, and Utah, as well as in Canada. A total of 2,505 units were involved in this recall.
Patients or healthcare providers who have this product should contact SurgiSmoke Solutions for information on how to proceed. Healthcare facilities should review their inventory to identify affected units and take appropriate action.
The recalled product
- Product
- Flamingo Funnel Large, Model Number SQ20012-03
- Manufacturer
- SurgiSmoke Solutions
- Affected units
- 2,505
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 408882777851966
- Lot 8264501
Distribution
Part of a larger recall action
This product is one of 3 recalled by SurgiSmoke Solutions under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · SurgiSmoke Solutions
See all →- ModerateFlamingo Funnel Medium surgical device recall due to sterilization incompatibility
FDA (Devices) · 2026-04-29
- ModerateFlamingo Funnel Small surgical device recalled for sterilization defect
FDA (Devices) · 2026-04-29
Other medical device recalls
- HighBD Phoenix Panel NMIC-312 recalled for classification error
FDA (Devices) · 2026-10-21
- ModerateMedline recalls CONMED AirSeal Access Port kits due to pressure alerts
FDA (Devices) · 2026-10-21
- SevereMedline Recalls Surgical Convenience Kits with Non-Conforming Cannula Components
FDA (Devices) · 2026-10-21
- ModerateMedline surgical convenience kits recalled for non-conforming cannula components
FDA (Devices) · 2026-10-21
- ModerateBioFire Joint Infection Panel Recalled for Potential Contamination
FDA (Devices) · 2026-10-21
Similar recalls
- SevereIntersurgical Flexible Breathing Circuit Recall Due to Exhalation Port Blockage Risk
FDA (Devices) · 2018-07-04
- HighIntersurgical Solus Flexible Laryngeal Mask Airways Recalled for Occlusion Risk
FDA (Devices) · 2017-12-13
- HighSymmetry Surgical ULTRA Steam Container Recall for Sealant Defect
FDA (Devices) · 2017-01-18
- HighCustomed Fanfold Drapes Recalled for Sterilization Process Validation Issues
FDA (Devices) · 2015-09-09
- ModerateAmerican Surgical Uniqcot Sponges Recalled for Packaging Sterility Defect
FDA (Devices) · 2016-06-01
- HighGMAX Non-Sterile Syringes Recalled Due to Regulatory Non-Compliance
FDA (Devices) · 2024-05-29