RegWardenFDA facility compliance records
Company

Bioventus LLC

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

Recalls by year

FDA actions on record by year2019: 1 recalls; 2020: 1 recalls201720181201912020202120222023202420252026
  • Recalls (2)

Registered facilities (2)

Recalls & enforcement

  • Class IITerminated2020-12-17
    Product may contain white particulates that are microbial in nature.
  • Class IITerminated2019-02-13
    The firm became aware of the potential for the products' sterile pouch to be punctured during transit. The packaging failure may introduce a non-sterile device that may lead to patient infection.

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. “Bioventus 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-10040666-bioventus-llc/

Not open yet

Alerts for Bioventus LLC

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.