The Recall Desk
HighFDA (Devices)·Z-1360-2022·Announced 2022-07-20

Isopure IsoMix PRO Mixing System Electrical Short Recall

Isopure is recalling approximately 119 units of the Sodium Bicarbonate Mixing and Distribution System due to an electrical short causing a thermal event and device damage. No injuries reported.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device with reported electrical hazard (short circuit causing thermal damage) presenting risk of fire or thermal injury. No illnesses, injuries, or deaths reported. Classified as High based on 'risk-of-harm products where injury has not yet been reported' criterion.

Plain-English summary

Isopure Corp is recalling approximately 119 units of the Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO). The systems are distributed across 23 U.S. states: Alabama, Arizona, Colorado, Delaware, Florida, Georgia, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New York, Oklahoma, Pennsylvania, Texas, Utah, Virginia, and West Virginia.

The recall was initiated following a report of an electrical short in one of the devices that resulted in a thermal event, damaging some device components. The electrical malfunction poses a potential risk of fire or thermal injury.

Consumers who own a recalled system should stop using the device and contact Isopure Corp for further guidance. Information about specific affected units, including serial numbers and UDI-DI codes, is available on the FDA recall notice.

The recalled product

Product
Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)
Manufacturer
Isopure Corp
Category
Medical Device
Hazard
Affected units
119

Distribution

Distributed in 23 states:

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