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FDA (Device enforcement)Recalled 2026-08-21class ii

Midmark Corporation: Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult a

Is my product affected?

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

  • UPC 00841709105821
  • UPC 00841709105906

Check against the official notice below — it lists the full affected range.

Hazard

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

Details from the source

Reason for recall: A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used. Distribution: US Nationwide distribution. Quantity: 20 units 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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