RegWardenFDA facility compliance records
Facility

VOCO GMBH

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

Activity by year

FDA actions on record by year2016: 1 recalls; 2019: 1 recalls; 2024: 1 recalls12016201720181201920202021202220231202420252026
  • Recalls (3)

Devices registered here (1)

Recalls & enforcement

  • Class IIOngoing2024-01-25
    Due to an error in the manufacturing process, it is possible that an incorrect plunger has been fitted to some capsules. This plunger does not contain the correct reactive component for Ionolux. When these capsules are activated, curing is significantly delayed and incomplete. Pr…
  • Class IITerminated2019-07-09
    The metal cannula are potentially too loose and may become loose when applying the filing material.
  • Class IITerminated2016-11-03
    Labeling mix-up: Futurabond M+ DCA (Dual Cure Activator) was marked labeled as Futurabond M+ Universal Adhesive.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “VOCO GMBH (FEI 3002718942) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002718942-voco-gmbh/

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