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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 119
Distribution
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