Ivoclar Vivadent, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0376-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

ExciTE F DSC Soft touch Single Dose, Dual-curing Regular Ref. 50 dental adhesive for restorations

Product Classification:

Class II

Date Initiated: September 23, 2013

Date Posted: November 27, 2013

Recall Number: Z-0376-2014

Event ID: 66359

Reason for Recall:

Ivoclar Vivadent, Inc. is recalling a lot of ExciTE F DSC Dental Adhesive found to produce a blue green discoloration when used in combination with cements.

Status: Terminated

Product Quantity: 63 refill packs (50 single use applications per refill)

Code Information:

Product Code 630378AN; Lot Number: R59595; Expiration date of 3 January 2015

Distribution Pattern:

US Distribution: including states of PA, WA, WI, NY, LA, TX, NJ, CA, OR, IA, SC, IN, IL, and AZ.

Voluntary or Mandated:

Voluntary: Firm initiated