FDA recall, , Moderate risk
Glypto Device, Glypto Cryo Machine
The Glypto Device and Glypto Cryo Machine lack 510(k) clearance.
Summary by Recall Canary from the FDA notice
What happened
Limitless Cryo Spa LLC of Ocean, New Jersey recalled the Glypto Device and Glypto Cryo Machine because they lack 510(k) clearance. The company began the recall on August 24, 2026, and the FDA added it to the Enforcement Report on October 2, 2026, with nationwide distribution in the US.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare these details with yours, then check the recall notice to see which units are recalled.
Glypto Device, Glypto Cryo Machine;
Recall details
- Company began the recall
- Sold in
US Nationwide distribution.
- Company
- Limitless Cryo Spa LLCOcean, New Jersey
- Hazard
- Unapproved product
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99811
- Recall number
- Z-0080-2027
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
