Medical device recalls Moderate risk

Young Dental Manufacturing Co, LLC recalls Oral-B, Practitioner Series, 5% Sodium Fluoride Varnish, 500 units (40mL/each) - Product Usage: For dentinal hypersensi…

Recall date
October 30, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0661-2020
FDA classification
Class II
Brand / firm
Young Dental Manufacturing Co, LLC
Sold / distributed
US Nationwide distribution in the states of MS, IN, MD, IL, TN, NJ, an ME.

Why it was recalled

Product shelf life may be shorter than that indicated on the label.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Oral-B, Practitioner Series, 5% Sodium Fluoride Varnish, 500 units (40mL/each) - Product Usage: For dentinal hypersensitivity and for the reduction of post-operative sensitivity.

Get recall alerts

Free email alert whenever Young Dental Manufacturing Co, LLC has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Young Dental Manufacturing Co, LLC