Isopure Corp

Complete recall history across all FDA and CPSC categories — 5 total recalls

Isopure Corp appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (5)

FDA medical device enforcement actions by Isopure Corp

Date Product Reason Class
Jul 26, 2022 Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Co... Acidified Concentrate Distribution System potential electrical safety hazard ... Class II
Apr 28, 2022 Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) Isopure received a report of a hazardous incident involving a device which ha... Class II
Apr 19, 2019 Finish Thompson Centrifugal Pump Model #110192-3 (sold as spare part) There is a potential for an uneven plastic encapsulation of the magnet ring d... Class II
Apr 19, 2019 Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a... There is a potential for an uneven plastic encapsulation of the magnet ring d... Class II
Apr 19, 2019 Acidified Concentrate Distribution and Storage System (ACDS System) with a Fi... There is a potential for an uneven plastic encapsulation of the magnet ring d... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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