Facility

ISOPURE, CORP.

3 recall(s) on record — most severe on record: Class II.

Key facts

3recalls · worst Class II

4inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3013942511
Establishment type	Manufacture Medical Device
Location	12500 Westport Rd. Louisville, KY, US 40245
Registration status	Active · expires 2026
Parent company	ISOPURE CORP. (owner-operator 9042051)
Brand names	Isocube; Aqua Caddy; Isopure Complete Water System for H

Activity by year

Recalls (3)
Inspections (4)

Devices registered here (1)

Subsystem, Water Purification
Product code FIP (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.5665

Recalls & enforcement

Class IITerminated2022-07-26
Acidified Concentrate Distribution System potential electrical safety hazard may result in electric shock, arching
Class IIOngoing2022-04-28
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 …
Class IITerminated2019-04-19
There is a potential for an uneven plastic encapsulation of the magnet ring during the molding process and partial axial displacement. This issue could cause uneven wear during use, cause exposure of the magnet to solution, and thereby result in corrosion and the presence of iron…

FDA inspections (4)

NAI2024-08-15
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2022-10-21
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
VAI2019-09-23
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2017-09-28
Voluntary Action Indicated · Compliance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by ISOPURE CORP.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “ISOPURE, CORP. (FEI 3013942511) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3013942511-isopure-corp/

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