The FDA has posted 5 enforcement recalls from Djo, LLC since 2025, none of them Class I (most serious). Most recent report: May 20, 2026.
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
The IFU (Information for Use) on the wrap instructs the user to heat the hot and cold compression wrap in the microwave for 3 minutes, which may cause the wrap to leak or break at the seams and/or reach temperatures capa…
Firm name as filed with the FDA: “DJO, LLC”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.