Surgismoke Solutions: Apparatus, Exhaust, Surgical
SurgiSmoke Solutions Recall Summary SurgiSmoke Solutions is recalling certain lots of the Flamingo Funnel Medium (Model SQ20012-02) surgical apparatus because some units contain a drape material that is not compatible with gamma sterilization, a standard sterilization method. The product was distributed across the United States, Canada, and specific states including California, Colorado, Georgia, Massachusetts, Maryland, Minnesota, New Hampshire, New York, Ohio, Tennessee, Texas, and Utah. This is classified as a Class II recall, meaning the product could potentially cause adverse health effects but is unlikely to cause serious injury.
- Recalling firm
- SurgiSmoke Solutions
- Product
- Flamingo Funnel Medium, Model Number SQ20012-02
- Reason
- Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-03-16
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, CO, GA, MA, MD, ME, MN, NH, NY, OH, TN, TX, and UT. The country of Canada.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/e2fbe5b3-b482-47f6-aac3-16cd2ef777c1