The Recall Desk

Manufacturer

Isopure Corp

5 recalls in our database name Isopure Corp as the manufacturing or recalling firm.

What the numbers show

Total
5
Critical
0
Severe
0
Most recent
2022-09-21

Of the 5 recalls from Isopure Corp we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–5 of 5

  • HighFDA (Devices)·Z-1739-2022·2022-09-21

    Isopure ACDS Hemodialysis Equipment Recalled for Electrical Shock Risk

    Isopure Corp recalls its ACDS (Acidified Concentrate Distribution and Storage) system used in hemodialysis facilities due to a potential electrical safety hazard that may result in electric shock or arcing.

    Product
    Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1360-2022·2022-07-20

    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.

    Product
    Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-0823-2020·2020-01-29

    Isopure Centrifugal Pump Recall Due to Magnet Encapsulation Defect

    Isopure Corp is recalling eight Finish Thompson Centrifugal Pumps due to a manufacturing defect that could expose magnets to solution, causing corrosion and iron contamination.

    Product
    Finish Thompson Centrifugal Pump Model #110192-3 (sold as spare part)
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-0821-2020·2020-01-29

    Isopure Acidified Concentrate Distribution System Recalled for Magnet Defect

    Isopure Corp is recalling 15 Acidified Concentrate Distribution and Storage Systems due to a potential magnet encapsulation defect that could cause corrosion and iron exposure.

    Product
    Acidified Concentrate Distribution and Storage System (ACDS System) with a Finish Thompson Centrifugal Pump Model #110192-3
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-0822-2020·2020-01-29

    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.

    Product
    Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centrifugal Pump Model #110192-3
    Category
    Medical Device
    Distribution
    13 states