Recall Z-2137-2026 ยท ILO Pack, Hot Or Cold, Water Circulating
DJO, LLC
Brand Name: DONJOY Product Name: ICEMAN, W/COLDPAD, NS, RH Model/Catalog Number: 11-9099 Software Version: No Product Description: 11-9099 - ICEMAN, W/COLDPAD, 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.
| Date | May 8, 2026 (initiated Mar 19, 2026) |
| Status | Open, Classified |
| Reason | Due to broken connector which may result in a temporary interruption of prescribed cold therapy. |
| 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 with |
| Quantity | 96 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.