RegWardenFDA facility compliance records
Company

Keystone Industries

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

Recalls by year

FDA actions on record by year2023: 3 recalls20172018201920202021202232023202420252026
  • Recalls (3)

Registered facilities (3)

Recalls & enforcement

  • Class IIOngoing2023-11-20
    Keyprint Keysplint Hard Clear 1 kg resin bottles were inadvertently packaged with the wrong Instructions for Use. Keysplint Hard Clear were placed inside a zip lock bag along with KeySplint Soft Instructions for Use (IFU).
  • Class IIOngoing2023-07-21
    A bottle of Copaliner Solvent was inadvertently packaged into a box labeled as Copaliner Varnish (0921526) and sold as Copaliner Varnish (0921526).
  • Class IIOngoing2023-04-10
    The Hard Line Chairside Reline Kit (570-0718) (0921940HS) was labeled as Soft Line Chairside Reline Kit (570-0717) (0921250HS) on the outer box. The contents of the Kit and the IFU enclosed with the kit were correctly labeled as Hard Line materials

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. “Keystone Industries — 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-9007845-keystone-industries/

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