Glypto Cryo Machine Recall: Lack of 510(k) Clearance
Limitless Cryo Spa LLC recalls 219 Glypto Cryo Machines due to lack of 510(k) clearance. This device may not be safe for medical use without proper regulatory approval.
Recall notice
Lack of 510(k) clearance.
What happened, in plain English
Limitless Cryo Spa LLC is recalling 219 Glypto Cryo Machines because they lack 510(k) clearance. This means the devices may not be safe for medical use without proper regulatory approval. Read more at govinfonow.com/recall/1629487-limitless-cryo-spa-llc-recalls-glypto-device-glypto-cryo-machine.
Source Summary by GovInfoNow · govinfonow.com/recall/1629487-limitless-cryo-spa-llc-recalls-glypto-device-glypto-cryo-machine · Updated October 21, 2026 · FDA enforcement record: FDA #Z-0080-2027
Cite this page
“Glypto Cryo Machine Recall: Lack of 510(k) Clearance.” GovInfoNow, updated October 21, 2026. https://govinfonow.com/recall/1629487-limitless-cryo-spa-llc-recalls-glypto-device-glypto-cryo-machine. Based on FDA recall #Z-0080-2027 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0080-2027%22&limit=1).
Why it’s dangerous
The Glypto Cryo Machines lack 510(k) clearance, which is required for medical devices in the U.S. This means the devices may not meet safety and effectiveness standards for medical use.
Who’s affected
Users of Glypto Cryo Machines distributed by Limitless Cryo Spa LLC through their 08/11/2026 operational hold are affected. Medical professionals using these devices without 510(k) clearance are at risk.
How to tell if you have this one
Check for Glypto Cryo Machines distributed by Limitless Cryo Spa LLC through their 08/11/2026 operational hold. The recall covers all units placed, held, loaned, inventoried, or supplied by the company.
- Brand
Limitless Cryo Spa- Category
Medical device
What to do — step by step
Check for Recall
Verify if your Glypto Cryo Machine was distributed by Limitless Cryo Spa LLC through their 08/11/2026 operational hold.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 51 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0080-2027 (August 24, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0080-2027 to see it in context.
- Plain-language summary written by qwen3:4b on October 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.