🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: July 19, 2022 Myolyn Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Myolyn Inc.
Reason for Recall:
Screws mounting an internal power supply may come loose during shipping resulting in increased risk of high voltage electrical shock.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1523-2022