Brand Name: DONJOY Product Name: ICEMAN CLASSIC CUBE Model/Catalog… — Class II medical device recall Z-2134-2026
Ongoing recall by DJO, LLC, reported 2026-05-20, distributed nationwide. Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
| Recall number | Z-2134-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | DJO, LLC, Carlsbad, CA, United States |
| Recall initiated | 2026-03-19 |
| Classified | 2026-05-08 |
| Reported by FDA | 2026-05-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 596 |
| UPC / GTIN / UDI-DI | 00888912003100 |
| Lot numbers | 146856, 146857, 146894, 146895 |
| Model numbers | 11-0494 |
Product
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 medical professional. The IceMan CLASSIC3 utilizes DonJoy's recirculation technology. Component: no
Reason for recall
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2134-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.