RegWardenFDA facility compliance records
Company

BIOPRO, INC.

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

Recalls by year

FDA actions on record by year2019: 1 recalls; 2022: 1 recalls; 2025: 1 recalls2017201812019202020211202220232024120252026
  • Recalls (3)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2025-09-09
    Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
  • Class IITerminated2022-02-01
    There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is M…
  • Class IITerminated2019-06-25
    Manufacturing flaw in the sterile barrier system

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. “BIOPRO, 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-9001497-biopro-inc/

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