Z-1523-2022Class II

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

Name: Z-1523-2022 Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2
Creator: Myolyn Inc.
Published: 2022-07-19
License: https://open.fda.gov/license/

Myolyn Inc. / initiated 2022-07-19 / Terminated / root cause: design

FDA source

Myolyn Inc. began a recall of Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2 on 2022-07-19. FDA classified it as Class II and gives the reason as "Screws mounting an internal power supply may come loose during shipping resulting in increased risk of high voltage electrical shock". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1523-2022
Classification: Class II
Status: Terminated
Initiated: 2022-07-19
Posted: 2022-08-16
Terminated: 2024-09-23
Recalling firm: Myolyn Inc.
Product: Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2.
Product code: GZI Stimulator, Neuromuscular, External Functional
Reason for recall: Screws mounting an internal power supply may come loose during shipping resulting in increased risk of high voltage electrical shock.
Root cause tag: design
FDA root cause: Device Design
Action: The recalling firm issued letters dated 7/19/2022 via email on 7/19/2022 informing the consignee of the reason for recall, risk to health, and action to be taken by the customer/user. The letter informs the addressee that the firm will ship a replacement power electronics box to all customers affected by the recall and the customers are asked to replace their original power electronics box with the new box and then return the original box to the recalling firm. The letter explains that instructions for replacing the box and a return UPS shipping label are enclosed with the replacement power electronics box. For customers who are unable or unwilling to replace their original power electronics box, a MYOLYN representative will travel to the customer location to perform the replacement. For customers who have received a device that has exhibited any signs of failure, they were instructed to discontinue use and disconnect it from the main electronical supply. If no power failures have been observed, customers can continue to use their device but should be cautious when transporting it to prevent the power supply mounting screws from loosening. The customer is to acknowledge receipt and understanding of the letter by clicking on the link in the letter or scanning the QR code to open the Recall Acknowledgement Form.
Quantity in commerce: 45 devices
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1523-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1523-2022	Class II	Terminated	Voluntary: Firm initiated	2022-08-24	2022-08-16

Product code GZI

K213925Class IIMyoCycle MC-2 (Home / Home + / Pro / Pro +)Myolyn, LLC / cleared 2022-04-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)