The Recall Desk
HighFDA (Devices)·Z-1523-2022·Announced 2022-08-24

Power Electronic Box Subassembly Loose Screws Pose Electrical Shock Risk

Myolyn Inc. is recalling the power electronic box subassembly for the MyoCycle MC-2 because internal mounting screws may come loose during shipping, creating a risk of electrical shock.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall involving risk of high voltage electrical shock. The hazard is potential—loose screws creating electrical shock risk—with no reported illnesses or injuries documented in the source.

Plain-English summary

Myolyn Inc. is recalling 45 units of the power electronic box, Part #AS-0066, a critical subassembly of the MyoCycle MC-2 exercise machine. The component houses the internal power supply and electrical circuitry.

The screws that mount the internal power supply within the device may come loose during shipping. This can result in an increased risk of high voltage electrical shock to users who handle or operate the equipment.

Affected devices were distributed to Arizona, California, Connecticut, Florida, Georgia, Idaho, Illinois, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New Mexico, New York, Ohio, Oregon, Texas, Utah, Virginia, Washington, and Wisconsin. Affected units have serial numbers 000800–000819, 000821–000822, 000824–000827, 000829–000831, 000835, 000836, 000840–000842, 000850–000852, and 000857–000859.

Consumers who own affected devices should immediately stop using the product and contact Myolyn Inc. for repair or replacement options.

The recalled product

Product
Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2.
Manufacturer
Myolyn Inc.
Hazard
  • electrical-shock
  • high-voltage
  • loose-screws

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (10)

  • 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

Distributed in 23 states:

  • AZ
  • CA
  • CT
  • FL
  • GA
  • ID
  • IL
  • KY
  • MA
  • MI
  • MN
  • MO
  • NC
  • NJ
  • NM
  • NY
  • OH
  • OR
  • TX
  • UT
  • VA
  • WA
  • WI