CLASS II ONGOING Device recall · Reported 20 May 2026 · FDA Enforcement Report
Donjoy Iceman W/,univ,loop,ns,eh recalled by DJO
DJO is recalling Donjoy Iceman W/,univ,loop,ns,eh, distributed nationwide in the US. The recall was initiated on 19 Mar 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-2136-2026
- FDA event ID
- 98638
- Recalling firm
- DJO, Carlsbad, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 Mar 2026
- FDA classified
- 8 May 2026
- Reported
- 20 May 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 19 Mar 2026 | Recall initiated by company | |
| 8 May 2026 | Classified by FDA | +50 days |
| 20 May 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
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Number: 11-1424 Software Version: No Product Description: 11-1424 - ICEMAN W/,UNIV,LOOP,NS,EH The IceMan CLASSIC3¿ cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMan¿ helps provide extended cold therapy to aid in a variety of indications and protocols as directed by a medical professional. The IceMan CLASSIC3 utilizes DonJoy's recirculation technology. Component: No
Where it was distributed
Worldwide - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MO, NC, NE. NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The country of Canada.
Nationwide AlaskaAlabamaArizonaCaliforniaColoradoFloridaGeorgiaIowaIdahoIllinoisIndianaKentuckyLouisianaMassachusettsMarylandMichiganMissouriNorth CarolinaNebraskaNew York
Questions about this recall
Why was it recalled?
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
Which lots are affected?
Model/Catalog Number: 11-1424 Lot Code: Lot: 110525 GTIN: 00888912017305
Where was it sold?
Worldwide - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MO, NC, NE. NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The country of Canada.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 98638| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Donjoy Iceman Classic Cube recalled by DJO | DJO | Device Malfunction | Nationwide | |
| CLASS II | Donjoy Iceman W/,univ,loop,ns,rh recalled by DJO | DJO | Device Malfunction | Nationwide | |
| CLASS II | Donjoy Iceman, W/coldpad, Ns, Rh recalled by DJO | DJO | Device Malfunction | Nationwide |
More recalls from DJO
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Donjoy Iceman, W/coldpad, Ns, Rh recalled by DJO | DJO | Device Malfunction | Nationwide |
| Device | CLASS II | Donjoy Iceman W/,univ,loop,ns,rh recalled by DJO | DJO | Device Malfunction | Nationwide |
| Device | CLASS II | Donjoy Iceman Classic Cube recalled by DJO | DJO | Device Malfunction | Nationwide |
| Device | CLASS II | Cold Form Wrap: Back recalled by DJO | DJO | Packaging Defects | Nationwide |
| Device | CLASS I | GEL Conductor, Description recalled by DJO | DJO | Other | Nationwide |
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