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U.S. Department of Health and Human Services

Class 2 Device Recall DONJOY

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 Class 2 Device Recall DONJOYsee related information
Date Initiated by FirmMarch 19, 2026
Date PostedMay 08, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2136-2026
Recall Event ID 98638
Product Classification Pack, hot or cold, water circulating - Product Code ILO
ProductBrand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Number: 11-1424 Software Version: No Product Description: 11-1424 - ICEMAN W/,UNIV,LOOP,NS,EH 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
Code Information Model/Catalog Number: 11-1424 Lot Code: Lot: 110525 GTIN: 00888912017305
FEI Number 3017264244
Recalling Firm/
Manufacturer		 DJO, LLC
5919 Sea Otter Pl Ste 200
Carlsbad CA 92010-6750
For Additional Information ContactKenneth Newman
682-299-9133
Manufacturer Reason
for Recall		Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
FDA Determined
Cause 2		Process control
ActionOn 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.
Quantity in Commerce480
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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