FDA Device recall Z-0810-2021
EXOGEN Ultrasound Coupling Gel
- FDA Device
- Class II
- terminated
- Published 2021-01-20
On 2021-01-20 the FDA classified a Class II recall of EXOGEN Ultrasound Coupling Gel by Bioventus, citing product may contain white particulates that are microbial in nature.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0810-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-12-17 |
| Published | 2021-01-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Bioventus |
| Distribution | US |
Product
EXOGEN Ultrasound Coupling Gel
Reason
Product may contain white particulates that are microbial in nature.
Identifiers
| code_info | UDI: M937710344001. Part #71034475, Lot # 190235, 200207; Part # 71034694, Lot # 190235, 190263, 200218, 200228; Part #…UDI: M937710344001. Part #71034475, Lot # 190235, 200207; Part # 71034694, Lot # 190235, 190263, 200218, 200228; Part # 71034695, Lot # 190235, 200207; Part # 81079892, Lot # 190204, 190211, 190213, 190226, 190228, 190250, 190251, 190252, 200212, 200215, 200227, 200229, 200240; Part # 81087015, Lot # 190215, 190230, 190235T, 200201, 200203, 200212T, 200215T, 200228T, 200240T |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0810-2021%22
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