CLASS II ONGOING Device recall · Reported 14 Oct 2026 · FDA Enforcement Report
Glypto Device, Glypto Cryo Machine recalled by Limitless Cryo
Limitless Cryo is recalling Glypto Device, Glypto Cryo Machine, distributed nationwide in the US. The recall was initiated on 24 Aug 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0080-2027
- FDA event ID
- 99811
- Recalling firm
- Limitless Cryo, Ocean, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Aug 2026
- FDA classified
- 2 Oct 2026
- Reported
- 14 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 24 Aug 2026 | Recall initiated by company | |
| 2 Oct 2026 | Classified by FDA | +39 days |
| 14 Oct 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of 510(k) clearance.
Product as listed by the FDA
Glypto Device, Glypto Cryo Machine;
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
Lack of 510(k) clearance.
Which lots are affected?
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.
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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