EXOGEN Ultrasound Coupling Gel — Class II medical device recall Z-0810-2021
Terminated recall by Bioventus, LLC, reported 2021-01-20, distributed nationwide. Product may contain white particulates that are microbial in nature.
| Recall number | Z-0810-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bioventus, LLC, Cordova, TN, United States |
| Recall initiated | 2020-12-17 |
| Classified | 2021-01-09 |
| Reported by FDA | 2021-01-20 |
| Terminated | 2024-08-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CH, CY, DE, DK, ES, FR, GB, HK, IE, IT, JP, NL, NO, PL, SE, ZA |
| Quantity | 115,584 units |
| Reason classes | microbial contamination, specification failure |
| Lot numbers | 190204, 190211, 190213, 190215, 190226, 190228, 190230, 190235, 190235T, 190250, 190251, 190252, 190263, 200201, 200203, 200207, 200212, 200212T, 200215, 200215T, 200218, 200227, 200228, 200228T, 200229, 200240, 200240T |
| Model numbers | 71034475, 71034694, 71034695, 81079892, 81087015 |
Product
EXOGEN Ultrasound Coupling Gel
Reason for recall
Product may contain white particulates that are microbial in nature.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0810-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.