Isopure Sodium Bicarbonate Mixing System Recalled for Magnet Encapsulation Defect
Isopure Corp is recalling one IsoMix PRO system due to a potential magnet encapsulation defect that could cause corrosion and iron exposure.
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: The recall involves a risk-of-harm product (potential iron contamination) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Isopure Corp is recalling one unit of the Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centrifugal Pump Model #110192-3. The recall is due to a potential manufacturing defect involving uneven plastic encapsulation of the magnet ring during the molding process.
This defect could cause partial axial displacement and uneven wear during use. These issues may expose the magnet to the solution, resulting in corrosion and the presence of iron. The product was distributed to facilities in Alabama, Florida, Georgia, Massachusetts, Maryland, Minnesota, North Carolina, New Mexico, New York, Ohio, Oklahoma, Texas, and Virginia.
The source text does not specify instructions for consumers or end-users on how to handle the recalled unit. The recall number is Z-0822-2020.
The recalled product
- Product
- Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centrifugal Pump Model #110192-3
- Manufacturer
- Isopure Corp
- Hazard
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- IsoMix Pro UDI: (01)00852456007085
- ISOMIX Serial Number IMP-838703 with Pump SN 180210D18
Distribution
Part of a larger recall action
This product is one of 3 recalled by Isopure Corp under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Isopure Corp
See all →- HighIsopure ACDS Hemodialysis Equipment Recalled for Electrical Shock Risk
FDA (Devices) · 2022-09-21
- HighIsopure IsoMix PRO Mixing System Electrical Short Recall
FDA (Devices) · 2022-07-20
- HighIsopure Centrifugal Pump Recall Due to Magnet Encapsulation Defect
FDA (Devices) · 2020-01-29
- HighIsopure Acidified Concentrate Distribution System Recalled for Magnet Defect
FDA (Devices) · 2020-01-29
Same hazard · contamination
See all →- SevereFDA Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- ModerateAvid Medical Recalls Robotic Prostatectomy Packs for Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls 23 ABD Hysterectomy Kits Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- ModerateAVID Medical Recalls GYN Laparoscopy Kits for Potential Lubricant Contamination
FDA (Devices) · 2026-10-14
Similar recalls
- HighIsopure IsoMix PRO Mixing System Electrical Short Recall
FDA (Devices) · 2022-07-20
- ModeratePreventive maintenance kit recalled over loosely tightened desiccant tube end caps
FDA (Devices) · 2025-09-17
- HighIntelliCuff Portable Automatic Cuff Pressure Controller Recall
FDA (Devices) · 2026-07-08
- ModerateInpeco FlexLab Centrifuge Module Recalled for Potential Load Imbalance
FDA (Devices) · 2020-05-13
- ModerateInpeco Siemens Aptio Centrifuge Module Recall for Tube Loading Algorithm Defect
FDA (Devices) · 2020-05-13
- ModerateBoston Scientific Recalls AMS 700 Reservoirs Due to Labeling Error
FDA (Devices) · 2020-05-27