Class II — Bioventus, LLC
| Recalling firm | Bioventus LLC |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Product may contain white particulates that are microbial in nature. |
| Product | EXOGEN Ultrasound Coupling Gel |
| Quantity | 115,584 units |
| Distribution | 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 |
| Initiated | 2020-12-17 |
| Classified | 2021-01-09 |
| Terminated | 2024-08-07 |
| Recall number | Z-0810-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Bioventus, LLC (Z-0810-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87002/
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