FDAFDA recall Z-0080-2027 · Oct 14, 2026
Limitless Cryo Spa LLC: Glypto Device recall
Recall found
Product
Glypto Device, Glypto Cryo Machine;
Reason for recall
Lack of 510(k) clearance.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- 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.
- Quantity
- 219
- Distribution
- US Nationwide distribution.
- Recalling firm
- Limitless Cryo Spa LLC, Ocean, NJ
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-08-24
Source: openFDA enforcement record Z-0080-2027 · search recall number Z-0080-2027 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.