Isopure Sodium Bicarbonate Mixing and Distribution System — Class II medical device recall Z-1360-2022
Ongoing recall by Isopure Corp, reported 2022-07-20, distributed in AL, AZ, CO, DE, FL, GA, IN, KS…. Isopure received a report of a hazardous incident involving a device which had experienced an electrical short
| Recall number | Z-1360-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Isopure Corp, Louisville, KY, United States |
| Recall initiated | 2022-04-28 |
| Classified | 2022-07-08 |
| Reported by FDA | 2022-07-20 |
| Distributed | AL, AZ, CO, DE, FL, GA, IN, KS, KY, LA, MA, MD, ME, MN, MO, NC, NY, OK, PA, TX, UT, VA, WV |
| Quantity | 119 |
| UPC / GTIN / UDI-DI | 00852456007085 |
| Serial numbers | 5201081501, 5202061411P, IMP-112232, IMP-112606, IMP-112737, IMP-112842, IMP-113085, IMP-113580, IMP-113620, IMP-113766, IMP-113809, IMP-113810, IMP-113811, IMP-113812, IMP-114975, IMP-114976, IMP-115144, IMP-115145, IMP-115146, IMP-115147, IMP-115148, IMP-116060, IMP-116155, IMP-116662, IMP-116996 and 96 more |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1360-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.