RegWardenFDA facility compliance records
Company

Turbett Surgical, Inc

3 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2022: 3 recalls20172018201920202021320222023202420252026
  • Recalls (3)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2022-12-05
    Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries.
  • Class IITerminated2022-04-14
    Devices were subject to unapproved rework processes.
  • Class IIOngoing2022-04-01
    Eight units manufactured before June 2019 have exhibited weld failures breaching the sterile barrier after prolonged use.

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. “Turbett Surgical, 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-10051785-turbett-surgical-inc/

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