# FDA recall Z-1523-2022

> **Myolyn Inc.** · Class II · device recall initiated 2022-07-19.

## Product

Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2.

## Reason for recall

Screws mounting an internal power supply may come loose during shipping resulting in increased risk of high voltage electrical shock.

## 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.

## Key facts

- **Recall number:** Z-1523-2022
- **Recalling firm:** Myolyn Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-07-19
- **Report date:** 2022-08-24
- **Termination date:** 2024-09-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Gainesville, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1523-2022

## Citation

> AI Analytics. FDA recall Z-1523-2022. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1523-2022. Source: US FDA. Licensed CC0.

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