Flamingo Funnel Small surgical device recalled for sterilization defect
SurgiSmoke Solutions is recalling certain lots of the Flamingo Funnel Small (Model SQ20012-01) due to a manufacturing issue 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. The source text identifies a manufacturing nonconformance (use of incompatible drape material) but does not report any illnesses, injuries, or hospitalization. The defect is a sterilization-process compatibility issue that reduces assurance of proper sterilization, qualifying as a non-critical manufacturing defect without reported harm.
Plain-English summary
SurgiSmoke Solutions is recalling certain lots of the Flamingo Funnel Small, Model Number SQ20012-01, a medical device used in surgical settings. The recall was initiated because of a manufacturing nonconformance: certain lots were produced using a drape that is not compatible with gamma sterilization, the standard sterilization method for this device.
Approximately 2,505 units were distributed. The affected product was distributed nationwide in California, Colorado, Georgia, Massachusetts, Maryland, Maine, Minnesota, New Hampshire, New York, Ohio, Tennessee, Texas, and Utah, as well as in Canada. The lot number associated with this recall is 8264701 (UDI-DI: 0860012888801).
Customers and healthcare facilities that have received this product should contact SurgiSmoke Solutions for instructions on return or replacement. Users should cease use of affected units.
The recalled product
- Product
- Flamingo Funnel Small, Model Number SQ20012-01
- 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: 0860012888801
- Lot 8264701
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
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