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

FDA device recall Z-2134-2026 · posted 2026-05-08 · Open, Classified

Recall details

Recalling firm

DJO, LLC

Reason for recall

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

Action taken

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 (Customer.Care@enovis.com). 4. To return affected product, please contact (Customer.Care@enovis.com) 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 productsafety@enovis.com or call/text 682-299-9133.

Root cause

Process control

Status

Open, Classified

Product code

ILO

Quantity affected

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 countr

Date initiated

2026-03-19

Date posted

2026-05-08

Location

Carlsbad, CA