Flamingo Funnel Medium surgical device recall due to sterilization incompatibility
SurgiSmoke Solutions is recalling certain lots of Flamingo Funnel Medium (Model SQ20012-02) because a non-gamma sterilization compatible drape was used during manufacturing, which could affect device safety.
What this means for you
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: FDA classified this as a Class II recall. The source text does not report any illnesses, injuries, or confirmed adverse events—only a manufacturing nonconformance with a drape material. This is a material-compatibility issue without reported harm, fitting the Moderate category.
Plain-English summary
SurgiSmoke Solutions is recalling certain lots of the Flamingo Funnel Medium, Model Number SQ20012-02 (UDI-DI: 0860012888818; Lot 8264601). The recall involves approximately 2505 units that were distributed nationwide across California, Colorado, Georgia, Massachusetts, Maryland, Maine, Minnesota, New Hampshire, New York, Ohio, Tennessee, Texas, and Utah, as well as Canada.
The product was manufactured with a non-gamma sterilization compatible drape, which represents a manufacturing nonconformance. This could compromise the device's integrity or function if it was subjected to gamma sterilization processes.
Healthcare facilities and users in the affected states and Canada who have this product should contact SurgiSmoke Solutions regarding return or replacement options. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Flamingo Funnel Medium, Model Number SQ20012-02
- Manufacturer
- SurgiSmoke Solutions
- Hazard
- sterilization-incompatibility
- manufacturing-defect
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: 0860012888818
- Lot 8264601
Distribution
Distributed nationwide across the United States.
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