Relief ACP Oral Care Gel intended to relieve discomfort from dentin sensitivity. Sold separately in single, single syringe, 4 packs, 6 packs and in teeth whitening kits

Recall Insight

This FDA Devices action (record #Z-0425-2015) was formally reported on December 3, 2014, with the manufacturer initiating the action on October 24, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Discus Dental LLC is listed as the recalling firm, operating out of Ontario, CA. Federal records indicate 20,251 distributed in U.S. on nationwide level and 14,653 internationally units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.

The documented reason for this recall is: Product sold after April 1, 2014 were inadvertently filled with hydrogen peroxide teeth whitening gel (6% concentration as dispensed) on one side of the dual barrel syringe instead of the intended component (phosphate g… Distribution data in the federal record shows the product reached: Worldwide distribution including Nationwide (U.S.) and the countries of New Zealand, Australia, Canada, Germany, Switzerland, Italy, Austria, Finland, South Africa, United Arab Emirates, Korea, Turkey, Egypt, Jordan, Th…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 12 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.