Class II — Potential Health Hazard

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

Grandio SO Heavy Flow Caps Recalled by Voco GmbH Due to The metal cannula are potentially too loose and...

Date: July 9, 2019
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

Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).

Quantity: 5 units

Why Was This Recalled?

The metal cannula are potentially too loose and may become loose when applying the filing material.

Where Was This Sold?

Distributed in the US to Iowa and New York

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