RegWardenFDA facility compliance records
Company

ISOPURE CORP.

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

Recalls by year

FDA actions on record by year2019: 1 recalls; 2022: 2 recalls201720181201920202021220222023202420252026
  • Recalls (3)

Registered facilities (1)

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…

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “ISOPURE CORP. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9042051-isopure-corp/

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