Limitless Cryo Spa LLC recalls Glypto Device
- Recalling company
- Limitless Cryo Spa LLC
- Product
- Glypto Device, Glypto Cryo Machine;
- Reason
- Lack of 510(k) clearance.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Aug 24, 2026
- Reported
- Oct 14, 2026
- Distribution
- US Nationwide distribution.
- Status
- Ongoing
- Quantity
- 219
- Lot / codes
- 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.
- Company location
- Ocean, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0080-2027
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0080-2027 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.