Medical device recalls Moderate risk

Bioventus, LLC recalls EXOGEN Ultrasound Coupling Gel

Recall date
December 17, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0810-2021
FDA classification
Class II
Brand / firm
Bioventus, LLC
Sold / distributed
United States (Nationwide), Australia, Austria, Belgium, Canada, Cyprus, Denmark, France, Germany, Hong Kong, Ireland, Italy, Japan, Netherlands, Norway, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom

Why it was recalled

Product may contain white particulates that are microbial in nature.

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

What was recalled

EXOGEN Ultrasound Coupling Gel

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