Class II U.S. Food and Drug Administration

Djo, LLC Brand Name: Donjoy Product Name: Iceman W/,Univ,Loop,NS,RH Model/ recall: Due to broken connector which may result in a temporary interruption

Recall published 5 months ago

Due to broken connector which may result in a temporary interruption of prescribed cold therapy.

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: Due to broken connector which may result in a temporary interruption of prescribed cold therapy.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2135-2026
Published
May 20, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Djo, LLC
Product type
Medical devices
Units affected
1412
Distribution
Nationwide
Made in
United States
Lot / code info
Model/Catalog Number: 11-1422 Lot Code: Lot: 101325, 101425 GTIN: 00888912005869
UPC codes
00888912005869

Products covered by this recall

Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,RH Model/Catalog Number: 11-1422 Software Version: no Product Description: 11-1422 - ICEMAN W/,UNIV,LOOP,NS,RH 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

Check your product

The notice names 2 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00888912005869

Model or item number

On the rating label, the box or the instruction sheet.

  • 11-1422 Software Version

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Djo, LLC — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: DJO, LLC — 5919 Sea Otter Pl Ste 200, Carlsbad, CA, 92010-6750

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Djo, LLC medical devices recalled?

Due to broken connector which may result in a temporary interruption of prescribed cold therapy. Due to broken connector which may result in a temporary interruption of prescribed cold therapy.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00888912005869; model number 11-1422 Software Version. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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