FDA Device recall Z-0080-2027
Glypto Device, Glypto Cryo Machine
- FDA Device
- Class II
- ongoing
- Published 2026-10-14
On 2026-10-14 the FDA classified a Class II recall of Glypto Device, Glypto Cryo Machine by Limitless Cryo Spa, citing lack of 510(k) clearance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0080-2027 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-24 |
| Published | 2026-10-14 |
| Last updated | 2026-10-21 05:30 UTC |
| Company | Limitless Cryo Spa |
| Distribution | US |
Product
Glypto Device, Glypto Cryo Machine;
Reason
Lack of 510(k) clearance.
Identifiers
| code_info | All Glypto units distributed, placed, held, loaned, inventoried, or otherwise supplied by/through Limitless through the…All Glypto units distributed, placed, held, loaned, inventoried, or otherwise supplied by/through Limitless through the 08/11/2026 operational hold; 08/20/2026 preliminary field notice. Serial/account-specific consignee list attached or to be supplemented. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-21 05:30 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0080-2027%22
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