Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)
Medical device recall Z-1360-2022. Published in FDA’s Enforcement Report on Jul 20, 2022.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jul 20, 2022. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- 23 states named in where it went
- 119 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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 events from occurring.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)
119, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: 00852456007085 Serial numbers: SERIAL # IMP-113766 5202061411P 5201081501 IMP-112232 IMP-120373 IMP-112737 IMP-112606 IMP-113620 IMP-113580 IMP-113085 IMP-112842 IMP-113812 IMP-119050 IMP-113811 IMP-114975 IMP-113810 IMP-115147…
Every code shown here, 1,379 characters
UDI-DI: 00852456007085 Serial numbers: SERIAL # IMP-113766 5202061411P 5201081501 IMP-112232 IMP-120373 IMP-112737 IMP-112606 IMP-113620 IMP-113580 IMP-113085 IMP-112842 IMP-113812 IMP-119050 IMP-113811 IMP-114975 IMP-113810 IMP-115147 IMP-115148 IMP-116155 IMP-116060 IMP-117241 IMP-115146 IMP-115145 IMP-116662 IMP-116996 IMP-117110 IMP-117278 IMP-117739 IMP-117979 IMP-118086 IMP-118103 IMP-118376 IMP-118568 IMP-118704 IMP-118765 IMP-119049 IMP-119343 IMP-118802 IMP-119503 IMP-119757 IMP-119788 IMP-120188 IMP-120172 IMP-120238 IMP-120699 IMP-120187 IMP-114976 IMP-119872 IMP-120959 IMP-120890 IMP-121099 IMP-121101 IMP-121883 IMP-117219 IMP-121980 IMP-122289 IMP-122582 IMP-122943 IMP-115144 IMP-123041 IMP-124680 IMP-825374 IMP-124893 IMP-825418 IMP-124862 IMP-124679 IMP-825865 IMP-826655 IMP-826884 IMP-826438 IMP-826928 IMP-826544 IMP-827363 IMP-827511 IMP-827244 IMP-830445 IMP-826812 IMP-827461 IMP-119513 IMP-827602 IMP-828401 IMP-119388 IMP-121100 IMP-829313 IMP-830965 IMP-831004 IMP-122583 IMP-830617 IMP-831413 IMP-831594 IMP-831197 IMP-831894 IMP-831929 IMP-832283 IMP-832381 IMP-832706 IMP-113809 IMP-832925 IMP-833088 IMP-833120 IMP-833428 IMP-833769 IMP-833916 IMP-833942 IMP-830374 IMP-120755 IMP-834278 IMP-833473 IMP-834575 IMP-834798 IMP-123026 IMP-835190 IMP-835138 IMP-835454 IMP-835973 IMP-838703 IMP-839160 IMP-840230 IMP-840914 IMP-831334 IMP-120670
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Domestic distribution to AL AZ CO DE FL GA IN KS KY LA MA MD ME MN MO NC NY OK PA TX UT VA WV No foreign distribution.
The states and territories these words name
23 states and territories.
Every one of them
- Alabama
- Arizona
- Colorado
- Delaware
- Florida
- Georgia
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Minnesota
- Missouri
- North Carolina
- New York
- Oklahoma
- Pennsylvania
- Texas
- Utah
- Virginia
- West Virginia
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Apr 28, 2022.
- FDA classified it on Jul 8, 2022.
- FDA’s Enforcement Report published it on Jul 20, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Isopure Corp, of Louisville, KY.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.