Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

VOCO Futurabond M+ adhesive Recalled by Voco GmbH Due to Labeling mix-up: Futurabond M+ DCA (Dual Cure Activator)...

Date: November 3, 2016
Company: Voco GmbH
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Voco GmbH directly.

Affected Products

VOCO Futurabond M+ adhesive, RF 1515, Manufactured by VOCO GmbH, Futurabond M+ is a dental adhesive for use with methacrylate-based restorative, core build-up or luting materials. It can be applied with phosphoric acid etching (selective enamel etching or total-etch) of the dental hard tissue as well as without (self-etch). A1] Adhesive for direct restorations of all classes of cavities using light-curing composite /compomer / Ormocer materials with a methacrylate base. [A2] Adhesive for core build-ups made of light-curing composite materials. [A3] Adhesive for indirect restorations with light-curing luting composites. [B] Intraoral repair of composite, compomer or Ormocer restorations, ceramic veneers and allceramic restorations without an additional primer. [C] Treatment of hypersensitive tooth necks. [D] Protective varnish for glass ionomer cement restorations. [E1] Sealing of cavities prior to amalgam restorations. [E2] Sealing of cavities and core preparations prior to the temporary luting of indirect restorations. In combination with Futurabond M+ DCA (Dual Cure Activator): [F1] Adhesive for direct self-curing or dual-curing composite restorations of all classes of cavities and for core build-ups.

Quantity: 50 units

Why Was This Recalled?

Labeling mix-up: Futurabond M+ DCA (Dual Cure Activator) was marked labeled as Futurabond M+ Universal Adhesive.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Voco GmbH

Voco GmbH has 4 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report