RegWardenFDA facility compliance records
Company

BLUE ORTHO

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

Recalls by year

FDA actions on record by year2019: 1 recalls; 2020: 1 recalls; 2024: 1 recalls2017201812019120202021202220231202420252026
  • Recalls (3)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2024-08-30
    Predict+ is being recalled for lack of pre-market clearance/approval.
  • Class IITerminated2020-09-10
    Appropriateness of the language used in the Tracker reprocessing instruction. Reason is that some Low Temperature sterilization conditions mentioned in the IFUs are approved based on rational documents.
  • Class IITerminated2019-09-22
    The navigated values displayed when using the LPI instrumentation are incorrect due to software inconsistencies (wrong data loaded).

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. “BLUE ORTHO — 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-10037278-blue-ortho/

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