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Djo, LLC FDA Recalls

7 recalls on file across devices, 2 of them Class I and 7 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product
Brand Name: DONJOY Product Name: ICEMAN CLASSIC CUBE Model/Catalog Number: 11-0494 Software Version: no Product DescClass IIMar 19, 2026Due to broken connector which may result in a temporary inte
Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,RH Model/Catalog Number: 11-1422 Software Version: no ProducClass IIMar 19, 2026Due to broken connector which may result in a temporary inte
Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Number: 11-1424 Software Version: No ProducClass IIMar 19, 2026Due to broken connector which may result in a temporary inte
Brand Name: DONJOY Product Name: ICEMAN, W/COLDPAD, NS, RH Model/Catalog Number: 11-9099 Software Version: No ProducClass IIMar 19, 2026Due to broken connector which may result in a temporary inte
Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02Class IISep 25, 2025The IFU (Information for Use) on the wrap instructs the user
GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO Class ISep 7, 2021Ultrasound gels and lotions manufactured by Eco-Med Pharmace
Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following Class ISep 7, 2021Ultrasound gels and lotions manufactured by Eco-Med Pharmace

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