MEDLINE MDSCC10Recalls & reported problems
Medline Industries, Inc. · CRYOCUBE, UNIT, COLD THERAPY · Class 2
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10193489079425), received between Sep 11, 2026 and Sep 30, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Insufficient Cooling” (3 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Cooling3
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Fluid/Blood Leak
It was reported that "They are concerned about moisture between the inner and outer shell and believes there may be a crack on inner shell causing leaking."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948898 ↗MalfunctionSep 25, 2026Insufficient Cooling
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906059 ↗MalfunctionSep 24, 2026Insufficient Cooling
It was reported that the cryocube does not stay cool.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889533 ↗MalfunctionSep 11, 2026Insufficient Cooling
It was reported that "Not cooling." Customer stated "they filled up to the ice line and cold water up to the water fill line and it still wont circulate cold water."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50735781 ↗
Other Pack, hot or cold, water circulating devices
- DONJOY 11-0494Djo, LLC · Pack, hot or cold, water circulating1 recall1 report
- DONJOY 11-1422Djo, LLC · Pack, hot or cold, water circulating1 recall1 report
- DONJOY 11-9099Djo, LLC · Pack, hot or cold, water circulating1 recall0 reports
- Micro-Temp LT 749Gentherm Medical, LLC · Pack, Hot Or Cold, Water Circulating1 recall0 reports
- DONJOY 11-1424Djo, LLC · Pack, hot or cold, water circulating1 recall0 reports
- Electri-Cool ll 767Gentherm Medical, LLC · Pack, Hot Or Cold, Water Circulating1 recall0 reports
- T/Pump TP700Stryker Corporation · Pack, hot or cold, water circulating15 reports
- Mul-T-Pad 8002-062-026Stryker Corporation · Pack, hot or cold, water circulating7 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.