RegWardenFDA facility compliance records
Company

Calyxo, Inc.

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

Recalls by year

FDA actions on record by year2025: 1 recalls20172018201920202021202220232024120252026
  • Recalls (1)

Registered facilities (2)

Recalls & enforcement

  • Class IOngoing2025-02-19
    Aspiration system, for endoscopic examination/treatment of urinary tract and kidney interior, to have labeling update adding additional instructions, for patients with high viscosity fluid in the kidney, not to continue providing fluid inflow in the presence of unresolved slow or…

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. “Calyxo, Inc. — 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-10058093-calyxo-inc/

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