Z-2134-2026Class II

Brand Name: DONJOY Product Name: ICEMAN CLASSIC CUBE Model/Catalog Number: 11-0494 Software Version: no...

Name: Z-2134-2026 Brand Name: DONJOY Product Name: ICEMAN CLASSIC CUBE Model/Catalog Number: 11-0494 Software Version: no...
Creator: Djo, Llc
Published: 2026-03-19
License: https://open.fda.gov/license/

DJO, LLC / initiated 2026-03-19 / Open, Classified / root cause: manufacturing process

FDA source

DJO, LLC began a recall of Brand Name: DONJOY Product Name: ICEMAN CLASSIC CUBE Model/Catalog Number: 11-0494 Software Version: no Product Description: 11-0494 - ICEMAN CLASSIC CUBE The... on 2026-03-19. FDA classified it as Class II and gives the reason as "Due to broken connector which may result in a temporary interruption of prescribed cold therapy". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2134-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-19
Posted: 2026-05-08
Recalling firm: DJO, LLC
Product: Brand Name: DONJOY Product Name: ICEMAN CLASSIC CUBE Model/Catalog Number: 11-0494 Software Version: no Product Description: 11-0494 - ICEMAN CLASSIC CUBE 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
Product code: ILO Pack, Hot Or Cold, Water Circulating
Reason for recall: Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 03/19/2026, the firm emailed an "Urgent: Medical Device Recall" Letter to customers to inform them that, twenty-nine complaints have been received reporting a consistent failure mode described as a broken connector. The connector is the component that attaches the end of the circulating hose from the cooler to the pad which is placed on/around the affected limb. Excess water leakage from this component is a key indicator of breakage. Customers are instructed to: Enovis (DJO, LLC) requires customers to take the following actions by 03-31-2026: This notice must be forwarded to all those within their organization or to any organization where the affected product has been transferred. 1. Review stock of the affected products and lot numbers to be returned. Quantities or affected product previously shipped are listed in the table at the opening of this letter. 2. Quarantine these devices from sale. 3. Complete the attached acknowledgment and response form and return to ([email protected]). 4. To return affected product, please contact ([email protected]) or call (800) 336-6569 option 4 and customers will be provided with a shipping label to return the affected product. 5. Return all affected products using the shipping label provided. For questions - contact Kenneth Newman at [email protected] or call/text 682-299-9133.
Quantity in commerce: 596
Distribution: 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.
Product codes and lots: Model/Catalog Number: 11-0494 Lot Code: Lots: 146894, 146895, 146856, 146857 GTIN: 00888912003100

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2134-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2134-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-20	2026-05-08
Z-2135-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-20	2026-05-08
Z-2136-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-20	2026-05-08
Z-2137-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-20	2026-05-08

Product code ILO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)