DONJOY 11-0494Recalls & reported problems
Djo, LLC · ICEMAN CLASSIC CUBE · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888912003100), received between Jul 6, 2026 and Jul 6, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Mar 19, 2026Open, Classified
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
Z-2134-2026 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Patient Device Interaction Problem1
Patient problems
- Burn(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 6, 2026Patient Device Interaction Problem
IT WAS REPORTED THAT A PATIENT SUSTAINED A COLD BURN WHILE USING THE ICEMAN UNIT, SEVERITY OF THE BURN INJURY IS UNKNOWN.
Patient problems: Burn(s)
MAUDE report 25727431 ↗
Other Pack, hot or cold, water circulating devices
- 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
- MEDLINE MDSCC20Medline Industries, Inc. · Pack, hot or cold, water circulating5 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.