HYGENIC Winged Fiesta Kit, Model no. H02778 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.

Recall Insight

This FDA Devices action (record #Z-2421-2020) was formally reported on July 1, 2020, with the manufacturer initiating the action on June 3, 2020. It is classified under Moderate severity (Class II), with a current status of Ongoing. Coltene Whaledent Inc is listed as the recalling firm, operating out of Cuyahoga Falls, OH. Federal records indicate 7,206 forceps units are affected.

The documented reason for this recall is: Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental dam clamps. Distribution data in the federal record shows the product reached: Pending. 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 6 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.