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Class IIOngoing

Midmark Corporation recalls 4 products

Recall date · record updated Sep 30, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Midmark Corporation
Reason
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
US Nationwide distribution.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99641…

Products (4)

  1. 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: 1-200-0320 with Kit Number: 4-000-0622

    Codes/lots: Model No: 1-200-0320; UDI-DI: 00841709105791; Kit No: 4-000-0622; UDI-DI: 00841709105876; Kit Serial Number: V2900924; Zone Serial Number: V2899738Quantity: 1 unitsRecall no. Z-3217-2026Class II

  2. 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

    Codes/lots: 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 V2877Quantity: 153 unitsRecall no. Z-3218-2026Class II

  3. 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

    Codes/lots: 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 V2886126Quantity: 20 unitsRecall no. Z-3219-2026Class II

  4. 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: 1-200-0360 with Kit Number: 4-000-0724

    Codes/lots: Model No: 1-200-0360; UDI-DI: 00841709105838; Kit No: 4-000-0724; UDI-DI: 00841709105913; Kit Serial Number: V2788703 V2788046 V2788016 V2788712 V2789302 V2789846 V2789830 V2789837 V2789808 V2789303 V2789304 V2811103 V2811112 V2862288 V2862275 V2869139 V2866577 V2867451 V2869599 V2868801 V2869154 V2868545 V2866984 V2869980 V2869969 V2868130 V2867433 V2868182 V2924525 V2924566 V2924559 V2924539 V2927525; Zone Serial Number: V2788322 V2787552 V2787555 V2788321 V2788905 V2789498 V2787554 V2789488 V2789499 V2788922 V2787553 V2807891 V2807893 V2837260 V2859050 V2868888 V2862992 V2866942 V2868893 V2Quantity: 33 unitsRecall no. Z-3220-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

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Proof: raw official record (JSON) · fetched from FDA API

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