Class II — Isopure Corp
| Recalling firm | ISOPURE CORP. |
|---|---|
| Registered facility | ISOPURE, CORP. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Isopure received a report of a hazardous incident involving a device which had experienced an electrical short that resulted in a thermal event, damaging some of the device components. The firm is alerting customers to electrical safety measures that can be taken to prevent such events from occurring. |
| Product | Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) |
| Quantity | 119 |
| Distribution | Domestic distribution to AL AZ CO DE FL GA IN KS KY LA MA MD ME MN MO NC NY OK PA TX UT VA WV No foreign distribution. |
| Initiated | 2022-04-28 |
| Classified | 2022-07-08 |
| Recall number | Z-1360-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Isopure Corp (Z-1360-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90389/
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