Data Foundry

Medical device recalls 2026

Brand Name: DONJOY Product Name: ICEMAN — Class II medical device recall Z-2137-2026

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 numberZ-2137-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmDJO, LLC, Carlsbad, CA, United States
Recall initiated2026-03-19
Classified2026-05-08
Reported by FDA2026-05-20
DistributedNationwide (US)
Countries outside the USCA
Quantity96
UPC / GTIN / UDI-DI00888912000376
Lot numbers110525
Model numbers11-9099

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 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-2137-2026. 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.