{"url_path":"/fda/device/recalls/Z-2134-2026","section_key":"summary","section_title":"DEVICE Recall: DJO, LLC — Brand Name: DONJOY  Product Name: ICEMAN CLASSIC CUBE  Model/Catalog Number: 11-0494  Software Version: no  Product Description: 11-0494 - ICEMAN CLASSIC CUBE  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 …","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-2134-2026%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":171,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2134-2026\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 CLASSIC CUBE  Model/Catalog Number: 11-0494  Software Version: no  Product Description: 11-0494 - ICEMAN CLASSIC CUBE  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: 11-0494 Lot Code: Lots: 146894, 146895, 146856, 146857 GTIN: 00888912003100\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."}