Class II — Myolyn Inc.
| Recalling firm | MYOLYN, INC |
|---|---|
| Registered facility | MYOLYN, INC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Screws mounting an internal power supply may come loose during shipping resulting in increased risk of high voltage electrical shock. |
| Product | Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2. |
| Quantity | 45 devices |
| Distribution | Distribution was made to AZ, CA, CT, FL, GA, ID, IL, KY, MA, MI, MN, MO, MN, NC, NJ, NM, NY, OH, OR, TX, UT, VA, WA, and WI. There was no foreign/military/government distribution. |
| Initiated | 2022-07-19 |
| Classified | 2022-08-16 |
| Terminated | 2024-09-23 |
| Recall number | Z-1523-2022 |
| 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 — Myolyn Inc. (Z-1523-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90620/
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