Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Glypto

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Glyptosee related information
Date Initiated by FirmAugust 24, 2026
Date PostedOctober 02, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0080-2027
Recall Event ID 99811
Product Classification Unit, cryosurgical, accessories - Product Code GEH
ProductGlypto Device, Glypto Cryo Machine;
Code Information 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.
FEI Number 3048646669
Recalling Firm/
Manufacturer		 Limitless Cryo Spa LLC
21 High Ridge Rd
Ocean NJ 07712-3460
For Additional Information ContactMarc C. Sanchez, Esq.
202-765-4491
Manufacturer Reason
for Recall		Lack of 510(k) clearance.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn August 24, 2026, Urgent Medical Device Recall letters were sent to customers. Actions to be taken: 1. Stop using every Glypto device immediately. 2. Unplug the device, clearly mark or tag it as QUARANTINED / DO NOT USE, and secure it in a location where it cannot be used pending removal from your facility or other writte n disposition instructions from Limitless. 3. Do not open, clean, service, repair, modify, move, ship, return, sell, transfer, loan, discard, or destroy any Glypto device or component unless Limitless provides written recall instructions. 4. Complete and return the attached Recall Response Form by the response due date above, even if you no longer have the device. 5. Read the serial number or other identifier from the device label/nameplate if present and provide it on the response form. If no label/nameplate is present or it cannot be read, state that on the form and attach clear device photos. 6. Identify the current location and status of each Glypto device and whether it is in your possession, in customer possession, in storage, loaned out, transferred, returned, or no longer available. 7. If you sold, transferred, loaned, placed, or otherwise provided a Glypto device to another person or entity, stop any further distribution and provide Limitless with the downstream recipient's name, telephone number, email, and address. 8. Preserve all Glypto-related records, including purchase, sales, service, repair, training, complaint, adverse-event, refund, text, email, Slack/direct-message, and downstream distribution records. 9. Report any complaint, device problem, injury, medical visit, service/repair issue, workaround, or other safety concern involving a Glypto device to Limitless.
Quantity in Commerce219
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
-
-