Ultradent PermaFlo Flowable Composite Recalled for Manufacturing Cross-Contamination
Ultradent Products, Inc. is recalling PermaFlo Flowable Composite due to a potential manufacturing issue causing cross-contamination and non-homogeneity.
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. The source text describes a manufacturing defect (cross-contamination/non-homogeneity) but does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Ultradent Products, Inc. is recalling 412 syringes (206 kits) of PermaFlo Flowable Composite, Shade A2 (Part Number 948, Lot Number BJR5W). The recall is due to a potential manufacturing issue involving cross-contamination, which has resulted in the composite being non-homogeneous.
The affected product is a light-cured, radiopaque, methacrylate-based flowable composite. The recall covers units distributed worldwide, including nationwide distribution in the United States and in Australia, Germany, Japan, and Mongolia.
Consumers and healthcare providers should stop using the affected product and contact Ultradent Products, Inc. for instructions on return or disposal.
The recalled product
- Product
- PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured, radiopaque, methacrylate based, flowable composite. PermaFlo contains H1¿m average particle size with narrow upper limit particle distribution.
- Manufacturer
- Ultradent Products, Inc.
Distribution
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