FDA Device recall Z-2135-2026
Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,RH Model/Catalog Number: 11-1422 Software Version: no Product Description: 11-1422…
- FDA Device
- Class II
- ongoing
- Published 2026-05-20
On 2026-05-20 the FDA classified a Class II recall of Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,RH Model/Catalog Number: 11-1422 Software Version: no Product Description: 11-1422… by Djo, citing due to broken connector which may result in a temporary interruption of prescribed cold therapy.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2135-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-03-19 |
| Published | 2026-05-20 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Djo |
| Distribution | US |
Product
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 directed by a medical professional. The IceMan CLASSIC3 utilizes DonJoy's recirculation technology. Component: No
Reason
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
Identifiers
| code_info | Model/Catalog Number: 11-1422 Lot Code: Lot: 101325, 101425 GTIN: 00888912005869 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2135-2026%22
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