{"url_path":"/fda/device/recalls/Z-2135-2026","section_key":"summary","section_title":"DEVICE Recall: DJO, LLC — 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 di…","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-03-19","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2135-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"DJO, LLC"},"word_count":167,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2135-2026\n\n**Recalling firm:** DJO, LLC\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-03-19\n**Report date:** 2026-05-20\n\n## Product\nBrand 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\n\n## Reason\nDue to broken connector which may result in a temporary interruption of prescribed cold therapy.\n\n## Affected lots\nModel/Catalog Number: 11-1422 Lot Code: Lot: 101325, 101425 GTIN: 00888912005869\n\n## Distribution\nWorldwide - 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."}