FDA Devices recall · Reported July 20, 2022
Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)
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 compon…
Isopure Corp recalled Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) - a moderate-severity action.
Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) was recalled by Isopure Corp in July 20, 2022. Reason: Isopure received a report of a hazardous incident involving a device which had experienced an electrical shor…. Check the official notice for the remedy. Verify recall #Z-1360-2022 with the FDA Devices before acting.
The recall
Isopure Corp issued this moderate-severity FDA Devices recall-Isopure received a report of a hazardous incident involving a device which had experienced an electrical shor….
- Moderate
- severity level
- 119 units
- affected scope
- Class II
- classification
- July 20, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1360-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1360-2022 |
| Date reported | July 20, 2022 |
| Date initiated | April 28, 2022 |
| Recalling firm | Isopure Corp |
| Firm location | Louisville, KY |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1360-2022) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026