Class II — SONEX HEALTH LLC
| Recalling firm | Sonex Health, Inc |
|---|---|
| Registered facility | SONEX HEALTH, Inc (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Potential of dull blade |
| Product | SX-One MicroKnife |
| Quantity | 3,752 devices |
| Distribution | US Nationwide distribution in the states of AZ, CA, CO, FL, GA, HI, ID, IN, KS, MD, MI, MN, MT, NE, NJ, NV, NY, OH, OK, OR, PA, TX, UT, VA, WI, WV, WY. |
| Initiated | 2022-06-29 |
| Classified | 2022-07-15 |
| Terminated | 2023-04-14 |
| Recall number | Z-1387-2022 |
| 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 — SONEX HEALTH LLC (Z-1387-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90520/
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