Gainesville, FL, United States
Myolyn Inc. recalls
1 recall recorded since 2018, most recently on 19 July 2022. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 19 July 2022
- Terminated
- 23 September 2024
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1523-2022
- Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.