Ongoing Class II Medical devices
- Recall started
- 24 August 2026
- Reason
- Lack of 510(k) clearance.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0080-2027
- Glypto Device, Glypto Cryo Machine;
Ocean, NJ, United States
Limitless Cryo Spa LLC recalls
1 recall recorded since 2018, most recently on 24 August 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
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.