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

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

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-3219-2026
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
20 units
Distribution
Nationwide
Made in
United States
Lot / code info
Model No: 1-200-0350; UDI-DI: 00841709105821; Kit No: 4-000-0722; UDI-DI: 00841709105906; Kit Serial Number: V2866143 V2866111 V2866124 V2864892 V2864113 V2864444 V2864120 V2864449 V2864894 V2866626 V2866636 V2871280 V2870561 V2869170 V2870570 V2869930 V2874364 V2897744 V2900961 V2900947; Zone Serial Number: V2864929 V2865546 V2864921 V2864495 V2796056 V2864174 V2858651 V2864142 V2873819 V2866216 V2866187 V2870249 V2870090 V2867500 V2866707 V2869394 V2873111 V2886635 V2873150 V2886126
UPC codes
00841709105821, 00841709105906

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: 1-200-0350 with Kit Number: 4-000-0722

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.

  • 00841709105821
  • 00841709105906

Model or item number

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

  • 1-200-0350

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 — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  3. Ask the supplier or clinic that provided it what the remedy is in your case.
  4. If you are a facility, quarantine affected stock and log the correction.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

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 00841709105821, 00841709105906; model number 1-200-0350. 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?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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