Isopure recalls

Isopure has 5 recalls on record with the FDA and USDA, the earliest in 2020 and the latest reported on 21 Sep 2022. 1 is still ongoing. The most frequent reason is foreign material.

Total recalls5since 2020

Last 12 months0reported

Class I00% of total

Ongoing1latest 21 Sep 2022

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 5 100%Class III 0 0%

Why isopure is recalled

Foreign Material360%
Other Reasons240%

Product types

Other Medical Devices5100%

By year

2022240%
2020360%

Ongoing isopure recalls

1 active

Reported	Class	Recall	Company	Reason	Where
20 Jul 2022Device	CLASS II	Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) recalled	Isopure	Other	19 states

All isopure recalls, newest first

5 total

Reported	Class	Recall	Company	Reason	Where
21 Sep 2022Device	CLASS II	Acidified Concentrate Distribution recalled by Isopure	Isopure	Other	Nationwide
20 Jul 2022Device	CLASS II	Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) recalled	Isopure	Other	19 states
29 Jan 2020Device	CLASS II	Finish Thompson Centrifugal Pump recalled by Isopure	Isopure	Foreign Material	13 states
29 Jan 2020Device	CLASS II	Sodium Bicarbonate Mixing and Distribution System recalled by Isopure	Isopure	Foreign Material	13 states
29 Jan 2020Device	CLASS II	Acidified Concentrate Distribution and Storage System recalled	Isopure	Foreign Material	13 states

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.