Class II — Potential Health Hazard

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

PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: Recalled by Ultradent Products, Inc. Due to Due to a potential manufacturing issue (cross contamination),...

Date: August 31, 2020
Company: Ultradent Products, Inc.
Status: Terminated
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 Ultradent Products, Inc. directly.

Affected Products

PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured, radiopaque, methacrylate based, flowable composite. PermaFlo contains H1¿m average particle size with narrow upper limit particle distribution.

Quantity: 412 syringes (206 kits)

Why Was This Recalled?

Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Ultradent Products, Inc.

Ultradent Products, Inc. has 23 total recalls tracked by RecallDetector.

Related Recalls

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