Summary
The FDA issued a Class II for Glypto Device, Glypto Cryo Machine; by Limitless Cryo Spa LLC. Reason: Lack of 510(k) clearance..
Details
Source
Device Recall
External ID
Z-0080-2027
Action Date
2026-10-14
Status
Ongoing
Category
device
Product Description
Glypto Device, Glypto Cryo Machine;
Lot/Code Info: 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 Affected: 219
Reason for Recall
Lack of 510(k) clearance.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-24
Company
Ocean, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 220 device recalls issued in the same week, part of 502 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Limitless Cryo Spa LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Limitless Cryo Spa LLC have FDA actions?
This is the only FDA action we have on record for Limitless Cryo Spa LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0080-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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