FDA recall record · openFDA

DJO, LLC

5 FDA recalls on record (2025–2026) — 5 device. 5 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Due to broken connector which may result in a temporary interruption of prescribed cold therapy. 4

The IFU (Information for Use) on the wrap instructs the user to heat the hot and cold compression wrap in the microwave 1

Recalls

Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Number: 11-1424 Software Version: No Produc Class II 2026-03-19 Brand Name: DONJOY Product Name: ICEMAN CLASSIC CUBE Model/Catalog Number: 11-0494 Software Version: no Product Desc Class II 2026-03-19 Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,RH Model/Catalog Number: 11-1422 Software Version: no Produc Class II 2026-03-19 Brand Name: DONJOY Product Name: ICEMAN, W/COLDPAD, NS, RH Model/Catalog Number: 11-9099 Software Version: No Produc Class II 2026-03-19 Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02 Class II 2025-09-25

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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