RegWardenFDA facility compliance records
Company

Tenacore LLC

1 recall(s) on record — most severe on record: Class I.

Recalls by year

FDA actions on record by year2021: 1 recalls20172018201920201202120222023202420252026
  • Recalls (1)

Registered facilities (1)

Recalls & enforcement

  • Class ITerminated2021-02-25
    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…

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Tenacore LLC — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10080555-tenacore-llc/

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