Recall archive / FDA device enforcement
Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2. — FDA record Z-1523-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jul 19, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2.
- Reason
- Screws mounting an internal power supply may come loose during shipping resulting in increased risk of high voltage electrical shock.
- Classification
- Class II
- Recalling firm
- Myolyn Inc.
- Quantity
- 45 devices
- Agency-reported status
- Terminated
- Source record identifier
- Z-1523-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Serial numbers 000800 thru 000819, 000821 thru 000822, 000824 thru 000827, 000829 thru 000831, 000835, 000836, 000840 thru 000842, 000850 thru 000852, and 000857 thru 000859; UDI 000861553000417 |
Match all identifying details in the current notice. A brand name alone is not enough.
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Aug 24, 2022
- Recall initiation date
- Jul 19, 2022
- Center classification date
- Aug 16, 2022
- Termination date
- Sep 23, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.