Ivoclar Vivadent Recalls ExciTE F DSC Dental Adhesive Due to Discoloration
Ivoclar Vivadent is recalling ExciTE F DSC Dental Adhesive because it produces blue-green discoloration when used with cements.
What this means for you
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, but the hazard is limited to cosmetic discoloration with no reported injuries or health risks, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Ivoclar Vivadent, Inc. is recalling a specific lot of ExciTE F DSC Soft touch Single Dose, Dual-curing Regular dental adhesive. The recall was initiated because the product was found to produce a blue-green discoloration when used in combination with cements.
The affected product is identified by Product Code 630378AN, Lot Number R59595, and an expiration date of January 3, 2015. The recall involves 63 refill packs, with each refill containing 50 single-use applications. The product was distributed in the United States, including the states of Pennsylvania, Washington, Wisconsin, New York, Louisiana, Texas, New Jersey, California, Oregon, Iowa, South Carolina, Indiana, Illinois, and Arizona.
This is a Class II recall. Consumers and dental professionals should check their inventory for the specific lot number and product code listed above. If the product matches the recalled lot, it should be removed from use and returned to the supplier or manufacturer according to their instructions.
The recalled product
- Product
- ExciTE F DSC Soft touch Single Dose, Dual-curing Regular Ref. 50 dental adhesive for restorations
- Manufacturer
- Ivoclar Vivadent, Inc.
- Category
- Medical Device — Dental Adhesive
- Hazard
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 (3)
- Product Code 630378AN
- Lot Number: R59595
- Expiration date of 3 January 2015
Distribution
Related recalls
Same manufacturer · Ivoclar Vivadent, Inc.
See all →- HighDental amalgam powder may not triturate properly, affecting restoration strength
FDA (Devices) · 2024-02-14
- LowIvoclar Vivadent Recalls Heliomolar Refill Due to Inconsistent Material Handling
FDA (Devices) · 2018-02-28
- LowIvoclar Vivadent Recalls Heliomolar Refill Due to Consistency Issues
FDA (Devices) · 2018-02-28
- LowIvoclar Vivadent Recalls Heliomolar Refill Due to Soft and Sticky Consistency
FDA (Devices) · 2018-02-28
- LowIvoclar Vivadent Recalls Heliomolar Refill Due to Consistency Issues
FDA (Devices) · 2018-02-28
Same hazard · discoloration
See all →- SevereShilpa Medicare Recalls Discolored Pemetrexed Injection Vials
FDA (Drugs) · 2026-08-26
- ModerateShilpa Medicare Recalls Discolored PEMRYDI RTU Injection Vials
FDA (Drugs) · 2026-08-26
- ModeratePantoprazole Sodium Tablets Recalled for Discoloration Issues
FDA (Drugs) · 2026-04-29
- ModerateTavaborole topical solution recalled from three lots because of discoloration
FDA (Drugs) · 2025-10-22
- ModerateAcetaminophen injection containers recalled after discoloration found in one lot
FDA (Drugs) · 2025-09-03