Class II U.S. Food and Drug Administration

Midmark IQvitals Zone, automatically and noninvasively measures recall: A performance issue may result in inaccurate blood pressure readings

Recall published 25 days ago

A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-3218-2026
Published
September 30, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Midmark Corporation
Product type
Medical devices
Units affected
153 units
Distribution
Nationwide
Made in
United States
Lot / code info
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 V2876486 V2872543 V2876578 V2870918 V2875573 V2875048 V2876034 V2876051 V2874521 V2874524 V2876622 V2876761 V2870921 V2876137 V2872026 V2872523 V2872034 V2886993 V2896054 V2897368 V2895831 V2896886 V2895538 V2895546 V2896839 V2895832 V2896877 V2896521 V2896903 V2896028 V2896862 V2895519 V2895829 V2895526 V2896025 V2895830 V2897374 V2896517 V2897832 V2897835 V2896871 V2896508 V2897367 V2897380 V2896912 V2913819 V2913772 V2883155 V2915485 V2917114 V2915045 V2917451 V2917113 V2918943 V2917115 V2918374 V2920114 V2916371 V2918949 V2919507 V2917112 V2889736 V2917916 V2913975 V2917913 V2915498 V2916373 V2914494 V2915051 V2915063 V2915903 V2915048 V2914512 V2919533 V2919471 V2919479 V2918944 V2918929 V2883461 V2917431 V2917912 V2917463 V2915904 V2915902 V2915505 V2914503 V2914493 V2915504 V2915901 V2916370 V2917915 V2917453 V2916368 V2913974 V2925899 V2926403 V2925236 V2926955 V2918377
UPC codes
00841709105807, 00841709105883

Products covered by this recall

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

Check your product

The notice names 3 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00841709105807
  • 00841709105883

Model or item number

On the rating label, the box or the instruction sheet.

  • 1-200-0330

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Midmark Corporation — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: Midmark Corporation — 60 Vista Dr, Versailles, OH, 45380-9488

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Midmark Corporation medical devices recalled?

A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used. A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00841709105807, 00841709105883; model number 1-200-0330. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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