Isopure Corp FDA Recalls

2 recalls on file across devices, 0 of them Class I and 1 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	Reason	Class	Initiated
Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with reClass IIJul 26, 2022Acidified Concentrate Distribution System potential electric	Acidified Concentrate Distribution System potential electrical safety hazard may result in electric shock, arc	Class IIDevices	Jul 26, 2022
Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)Class IIApr 28, 2022Isopure received a report of a hazardous incident involving	Isopure received a report of a hazardous incident involving a device which had experienced an electrical short	Class IIDevices	Apr 28, 2022