Recall Z-2137-2026— DJO, LLC
Class II · Ongoing
Class II FDA medical device recall by DJO, LLC, initiated 2026-03-19. FDA's recall record names no specific 510(k) clearance for this event. Product: Brand Name: DONJOY Product Name: ICEMAN, W/COLDPAD, NS, RH Model/Catalog Number: 11-9099 Software Version: No Product Description: 11-9099 - ICEMAN, W/COLDPAD, 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..
- Recalling firm
- DJO, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-03-19
- Firm location
- Carlsbad, CA, United States
Product description
Brand Name: DONJOY Product Name: ICEMAN, W/COLDPAD, NS, RH Model/Catalog Number: 11-9099 Software Version: No Product Description: 11-9099 - ICEMAN, W/COLDPAD, 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 for recall
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
Data sourced from openFDA. This site is unofficial and independent of the FDA.