Myolyn Inc.: Medical Device Recall in 2022 - (Recall #: Z-1523-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 19, 2022

Date Posted: August 24, 2022

Recall Number: Z-1523-2022

Event ID: 90620

Reason for Recall:

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

Status: Terminated

Product Quantity: 45 devices

Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated