Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany 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.). Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.).
Brand
Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany
Lot Codes / Batch Numbers
Item Number 2706, Lot Number 1923282, Expiration Date 12/28/2021
Products Sold
Item Number 2706; Lot Number 1923282; Expiration Date 12/28/2021
Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany is recalling Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all cla due to The metal cannula are potentially too loose and may become loose when applying the filing material.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The metal cannula are potentially too loose and may become loose when applying the filing material.
Recommended Action
Per FDA guidance
VOCO GmbH notified customers on about 07/09/2019 via email. The letter in the email informed customers that the metal cannula are partly too loose and therefore could become loose when applying the material. VOCO GmbH instructed that affected products must be returned immediately and requested that they notify customers if affected product was further distributed.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN, IA, NY
Page updated: Jan 10, 2026