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Tenacore LLC

United Statesfrom the FDA registration address FDA establishment FEI 3008403701

Devices
0
Registrations
FDA
FDA recalls
2

No devices from this company are in the catalogue yet.

Company details

FDA FEI number
3008403701
Address
3115 Airway Ave, Costa Mesa, CA, 92626

FDA recalls2

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 2
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

  • 2021

    • 25 Feb 2021 Z-1331-2021 Class I Terminated Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of one or more bezel repair part posts may result in free flow, over infusion, under infusion or interruption of infusion. Distribution: US distribution to states of: WA, AZ, NY, TX, LA, CA, NV, ME, MN, DE, NC, FL, MO, KY, TN, and PA Submission number: K133532
    • 25 Feb 2021 Z-1332-2021 Class I Terminated Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of one or more bezel repair part posts may result in free flow, over infusion, under infusion or interruption of infusion. Distribution: US distribution to states of: WA, AZ, NY, TX, LA, CA, NV, ME, MN, DE, NC, FL, MO, KY, TN, and PA Submission number: K133532

This is an FDA establishment record without devices in deviCERTS.