Recall Z-2135-2026
Djo, LLC · initiated March 19, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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
Codes / lots: Model/Catalog Number: 11-1422 Lot Code: Lot: 101325, 101425 GTIN: 00888912005869
Reason for recall
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
FDA-determined cause: Process control
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.
Details
- Recall number
- Z-2135-2026
- Initiated
- March 19, 2026
- Posted by FDA
- May 8, 2026
- Product code
- ILO – Pack, Hot Or Cold, Water Circulating
- Quantity
- 1412
- 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.
- Recalling firm
- Djo, LLC, Carlsbad, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2134-2026 Class II | Brand Name: DONJOY Product Name: ICEMAN CLASSIC CUBE Model/Catalog Number: 11-0494…Due to broken connector which may result in a temporary interruption of prescribed cold therapy. | 03/19/2026Open, Classified |
| Z-2136-2026 Class II | Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Number: 11-1424…Due to broken connector which may result in a temporary interruption of prescribed cold therapy. | 03/19/2026Open, Classified |
| Z-2137-2026 Class II | Brand Name: DONJOY Product Name: ICEMAN, W/COLDPAD, NS, RH Model/Catalog Number: 11-9099…Due to broken connector which may result in a temporary interruption of prescribed cold therapy. | 03/19/2026Open, Classified |