# Class II recall Z-0080-2027: Limitless Cryo Spa LLC

**Predicate Speed & CAPA Advisory Opportunity Score:** 62/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0080-2027 |
| Recalling firm | Limitless Cryo Spa LLC |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | Glypto Device, Glypto Cryo Machine; |
| Reason | Lack of 510(k) clearance. |
| Quantity | 219 |
| Distribution | US Nationwide distribution. |
| Recall initiated | 2026-08-24 |
| Reported | 2026-10-14 |
| Firm location | Ocean, NJ, United States |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 21 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0080-2027%22). Last refreshed: 2026-11-03T18:05:14.713Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.