DONJOYRecalls & reported problems across all models
Djo, LLC · 11 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
4 open recalls name at least one DONJOY model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls
- 4
We found 11 models of DONJOY by Djo, LLC in the FDA's device registry (GUDID). Together they are named in 10 adverse event reports in the FDA's MAUDE database, received between Jan 19, 2017 and Jul 6, 2026 — classified as 6 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (2 reports).
4 FDA recall records name at least one of these models by its device identifier, 4 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
DONJOY recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Mar 19, 2026Open, Classified
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
Z-2137-2026 · Root cause: Process control · Recall details · FDA record ↗
- Mar 19, 2026Open, Classified
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
Z-2136-2026 · Root cause: Process control · Recall details · FDA record ↗
- Mar 19, 2026Open, Classified
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
Z-2135-2026 · Root cause: Process control · Recall details · FDA record ↗
- 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 · Recall details · FDA record ↗
Most reported DONJOY problems
Device problems
- Adverse Event Without Identified Device or Use Problem4
- Mechanical Problem2
- No Apparent Adverse Event2
- Unintended System Motion2
- Fluid/Blood Leak1
- Leak/Splash1
- Patient Device Interaction Problem1
- Sparking1
Patient problems
- Burn(s)2
- No Clinical Signs, Symptoms or Conditions2
- No Information2
- Discomfort1
- No Known Impact Or Consequence To Patient1
- Rash1
- Unspecified Tissue Injury1
DONJOY models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- DONJOY 11-0494Pack, hot or cold, water circulating1 recall1 report
- DONJOY 11-1422Pack, hot or cold, water circulating1 recall1 report
- DONJOY 11-9099Pack, hot or cold, water circulating1 recall0 reports
- DONJOY 11-1424Pack, hot or cold, water circulating1 recall0 reports
- DONJOY 11-0021-3JOINT, KNEE, EXTERNAL BRACE2 reports
- DONJOY 11-0493Pack, hot or cold, water circulating1 report
- DONJOY 11-0679-9-00000Pack, hot or cold, water circulating1 report
- DONJOY 11-0682-9-00000Pack, hot or cold, water circulating1 report
- DONJOY 11-1334-9-00000Pack, hot or cold, water circulating1 report
- DONJOY 11-1316-0-02000Pack, hot or cold, water circulating1 report
- DONJOY 11-1640Pack, hot or cold, water circulating1 report
Recent DONJOY adverse event reports
The 10 most recent reports across all models, 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 ↗MalfunctionSep 14, 2024Mechanical Problem; Unintended System Motion; No Apparent Adverse Event; Mechanical Problem; Unintended System Motion; No Apparent Adverse Event
IT WAS REPORTED THAT THE RED BUTTON BROKE AND WILL NOT LOCK OUT .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20219170 ↗MalfunctionAug 14, 2024Mechanical Problem; Unintended System Motion; No Apparent Adverse Event; Mechanical Problem; Unintended System Motion; No Apparent Adverse Event
IT WAS REPORTED THAT ROM RESTRICTION DOES NOT LOCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19987482 ↗InjuryMay 5, 2021Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY THE HOSPITAL STAFF THAT A COLD THERAPY MACHINE (ICEMAN CLASSIC CUBE) ALLEGEDLY CAUSED TISSUE DAMAGE AFTER THE PATIENT HAD THE UNIT FOR 2 DAYS.
Patient problems: Unspecified Tissue Injury
MAUDE report 11780300 ↗MalfunctionOct 22, 2019Leak/Splash
PATIENT FOUND TO HAVE A WET ACE WRAP FROM THE COLD THERAPY PAD. UNSURE WHERE THE PAD WAS LEAKING WATER. PAD REMOVED, ACE WRAP REAPPLIED. DRESSING UNDERNEATH ACE WRAP WAS DRY AND INTACT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9218292 ↗InjuryAug 5, 2019Sparking; Sparking
IT WAS REPORTED THAT SPARKS CAME OUT OF THE POWER CORDS, AND THE END USER SUFFERED SOME DEGREE OF BURNING. IT IS UNKNOWN IF THIS WAS ON ACCOUNT OF THE FORMENTIONED SPARKS OR DUE TO FROSTBITE. FURTHER INFORMATION WAS REQUESTED.
Patient problems: Burn(s)
MAUDE report 8860952 ↗MalfunctionMar 27, 2018Fluid/Blood Leak; Fluid/Blood Leak
COMPLAINT RECEIVED THAT ALLEGES "FOLLOWING AN OPERATION FOR A TOTAL KNEE REPLACEMENT, AS PART OF RECOVERY I WAS GIVEN A KNEE PAD FILLED WITH ICY WATER TO HELP REDUCE THE SWELLING, ITEM TO BE USE AT HOME. IT SPRUNG A LEAK BUT UNFORTUNATELY THE WATER CAME OUT IN A JET AND LANDED FURTHER AWAY ON CUSTOMER LAPTOP. LAPTOP DESTROY AND HAD TO BUY A NEW ONE".
Patient problems: No Information
MAUDE report 7374838 ↗InjuryMar 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
COMPLAINT RECEIVED THAT ALLEGES "HE PUT DEVICE ON A TV TRAY WHEN GOING TO BED AND CONDENSATION CAUSED IT TO SLIDE AND PULL HIS SHOULDER. HUNG UP BEFORE COMPLETING INFORMATION. WHEN I CALLED BACK HE STATED HE WOULDN'T SAY ANYTHING ELSE, AND THAT WE SPEAK TO HIS ATTORNEY AND HE WOULD SUE THE COMPANY".
Patient problems: No Information
MAUDE report 7366743 ↗InjuryApr 25, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
COMPLAINT RECEIVED THAT ALLEGES "WHILE IN THE HOSPITAL YESTERDAY THE PAD WAS APPLIED WITHOUT A BARRIER WHICH CAUSED THE KNEE TO GET ICE BURN. THE KNEE IS RED AND PAINFUL TO THE TOUCH". QUESTIONNAIRE NOT RECEIVED FROM CUSTOMER OR CLINICIAN. DEVICE NOT RETURNED TO MANUFACTURER FOR EVALUATION.
Patient problems: Discomfort
MAUDE report 6518928 ↗InjuryJan 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
COMPLAINT RECEIVED THAT ALLEGES "DEVELOPED A RASH ON HER ARM FROM WETNESS SHE FELT COMING FROM THE PAD. EXPERIENCED ITCHING REDNESS AND DISCOLORIZATION ON HER SKIN. SHE SAYS THAT SHE HAD A TOWEL BETWEEN THE PAD AND SKIN. WENT TO ER RECEIVED BENADRIL AND ANTI-BIOTICS". QUESTIONNAIRE NOT RECEIVED FROM CUSTOMER OR CLINICIAN. DEVICE NOT RETURNED TO MANUFACTURER FOR EVALUATION.
Patient problems: Rash
MAUDE report 6264316 ↗
Other Djo, LLC products
All Djo, LLC devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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