SurgiSmoke Solutions

United Statesfrom the FDA registration address FDA establishment FEI 3008493151

Devices: 0
Registrations: FDA
FDA recalls: 33 ongoing

No devices from this company are in the catalogue yet.

Company details

FDA FEI number: 3008493151
Address: 2300 Myrtle Ave Ste 200, Saint Paul, MN, 55114

FDA recalls3

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

Recalls initiated per year

2017 0
2018 0
2019 0
2020 0
2021 0
2022 0
2023 0
2024 0
2025 0
2026 3

2026
- 16 Mar 2026 Z-1924-2026 Class II Ongoing Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape. Distribution: Worldwide - US Nationwide distribution in the states of CA, CO, GA, MA, MD, ME, MN, NH, NY, OH, TN, TX, and UT. The…
  Full distribution text
  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.
  Submission number: K894038
- 16 Mar 2026 Z-1925-2026 Class II Ongoing Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape. Distribution: Worldwide - US Nationwide distribution in the states of CA, CO, GA, MA, MD, ME, MN, NH, NY, OH, TN, TX, and UT. The…
  Full distribution text
  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.
  Submission number: K894038
- 16 Mar 2026 Z-1926-2026 Class II Ongoing Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape. Distribution: Worldwide - US Nationwide distribution in the states of CA, CO, GA, MA, MD, ME, MN, NH, NY, OH, TN, TX, and UT. The…
  Full distribution text
  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.
  Submission number: K894038

This is an FDA establishment record without devices in deviCERTS.