VOCO Futurabond M+ adhesive recalled for labeling mix-up
Voco GmbH is recalling 50 units of VOCO Futurabond M+ adhesive due to a labeling error where the product was marked as Futurabond M+ Universal Adhesive.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Voco GmbH is recalling 50 units of VOCO Futurabond M+ adhesive, reference number 1515, lot number 1636479. The recall is due to a labeling mix-up where the product was marked as Futurabond M+ Universal Adhesive instead of its correct identification.
The affected product is a dental adhesive used with methacrylate-based restorative, core build-up, or luting materials. It is distributed nationwide to Florida, Iowa, New Hampshire, Pennsylvania, South Carolina, and Texas.
Consumers and dental professionals should stop using the affected units and contact Voco GmbH for further instructions or a replacement.
The recalled product
- Product
- 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…
- Manufacturer
- Voco GmbH
- Category
- Medical Device — Dental Adhesive
- Hazard
- Affected units
- 50
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- REF #1515
- Lot no. 1636479
Distribution
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