Surgismoke Solutions: Apparatus, Exhaust, Surgical
- Recalling firm
- SurgiSmoke Solutions
- Product
- Flamingo Funnel Large, Model Number SQ20012-03
- 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/91d536bf-2ea4-4b8c-b0bc-939587ce7fcd