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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