Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse…
Medical device recall Z-3218-2026. Published in FDA’s Enforcement Report on Sep 30, 2026.
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 Sep 30, 2026. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 153 units 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?
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients, Model Number: 1-200-03300 with Kit Number: 4-000-0624
153 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model No: 1-200-0330; UDI-DI: 00841709105807; Kit No: 4-000-0624; UDI-DI: 00841709105883; Kit Serial Number: V2842901 V2841713 V2841724 V2842133 V2842105 V2841750 V2841701 V2842116 V2842081 V2842097 V2866067 V2871822 V2871211 V2871204…
Every code shown here, 1,993 characters
Model No: 1-200-0330; UDI-DI: 00841709105807; Kit No: 4-000-0624; UDI-DI: 00841709105883; Kit Serial Number: V2842901 V2841713 V2841724 V2842133 V2842105 V2841750 V2841701 V2842116 V2842081 V2842097 V2866067 V2871822 V2871211 V2871204 V2871817 V2881636 V2878754 V2878741 V2878759 V2879975 V2879979 V2879564 V2880715 V2880713 V2881270 V2880698 V2880711 V2879544 V2881253 V2882161 V2881704 V2882141 V2881259 V2881258 V2881698 V2881677 V2881684 V2879566 V2882146 V2879551 V2877649 V2877655 V2877673 V2880021 V2878308 V2878306 V2878734 V2877678 V2878299 V2878294 V2880023 V2875958 V2875328 V2877119 V2877065 V2874409 V2877114 V2874415 V2875941 V2875331 V2876441 V2876423 V2874794 V2874786 V2877057 V2877131 V2873684 V2876410 V2876449 V2873677 V2876455 V2888858 V2896346 V2897752 V2896689 V2897157 V2895863 V2899478 V2898923 V2896355 V2898561 V2896708 V2897134 V2896352 V2898573 V2895879 V2899469 V2895878 V2899455 V2898942 V2898200 V2896720 V2898188 V2898192 V2898563 V2898930 V2897759 V2897764 V2897128 V2914273 V2914285 V2914304 V2915752 V2918767 V2915294 V2917735 V2920483 V2919267 V2918780 V2918750 V2920462 V2920473 V2919288 V2919879 V2917216 V2915308 V2918123 V2914243 V2918146 V2916948 V2917204 V2914807 V2915283 V2915770 V2916220 V2915298 V2914786 V2920109 V2919859 V2919892 V2919298 V2919281 V2917241 V2917747 V2918173 V2917727 V2916228 V2916203 V2915760 V2914792 V2914817 V2915785 V2916239 V2916929 V2918139 V2917715 V2916785 V2914256 V2928158 V2928139 V2928117 V2928129 V2928148; Zone Serial Number: L1187570 V2839311 V2840480 V2841440 V2841442 V2839313 V2838889 V2841435 V2839314 V2841486 V2846602 V2845499 V2845501 V2866711 V2845500 V2881442 V2878467 V2878461 V2877997 V2879643 V2879586 V2878874 V2880188 V2880175 V2877380 V2880218 V2880199 V2878949 V2880749 V2881496 V2881388 V2881510 V2877999 V2878828 V2881403 V2881416 V2881439 V2878838 V2881509 V2878895 V2877353 V2877331 V2876771 V2879576 V2877377 V2877386 V2878004 V2876760 V2877894 V2877903 V2879624 V2875578 V2875077 V2876138…
FDA’s list runs to 2,883 characters. The first part is shown; the rest is on FDA’s record.
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.
US Nationwide distribution.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
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 Aug 21, 2026.
- FDA classified it on Sep 18, 2026.
- FDA’s Enforcement Report published it on Sep 30, 2026.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Midmark Corporation, of Versailles, OH.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
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.”
- FDA’s list of codes runs to 2,883 characters; the first part is shown here, and the rest is on FDA’s record.
- 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
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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.