Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

HYGENIC Winged Fiesta Kit Recalled by Coltene Whaledent Inc Due to Multiple Coltene batches of the product have a...

Date: June 3, 2020
Company: Coltene Whaledent Inc
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Coltene Whaledent Inc directly.

Affected Products

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.

Quantity: 7,206 forceps

Why Was This Recalled?

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.

Where Was This Sold?

Pending

About Coltene Whaledent Inc

Coltene Whaledent Inc has 14 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report