Darby Dental Supply Compolite Bond SE Self-Etch/Light-Cur... (Novocol, Inc.) – septodont is recalling self-etch bond... (2014)
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Darby Dental Supply Compolite Bond SE Self-Etch/Light-Curing. This product is used to adhere restorative material to the tooth during restorations. Package contains 100 0.125 mL unit dose tips, 100 applicator brushes, and a product insert.
Brand
Novocol, Inc.
Lot Codes / Batch Numbers
Product Order Number 950-9119, Lot Number C4211-3, UPC Code *950-9119*, Expiration Date September 2015.
Products Sold
Product Order Number 950-9119; Lot Number C4211-3; UPC Code *950-9119*; Expiration Date September 2015.
Novocol, Inc. is recalling Darby Dental Supply Compolite Bond SE Self-Etch/Light-Curing. This product is used to adhere restor due to Septodont is recalling Self-Etch bond because the material was incorrectly packaged.. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Septodont is recalling Self-Etch bond because the material was incorrectly packaged.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
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, NY, OR, PA, VA
Page updated: Jan 10, 2026