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U.S. Department of Health and Human Services

Class 2 Device Recall IQvitals Zone

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 Class 2 Device Recall IQvitals Zonesee related information
Date Initiated by FirmAugust 21, 2026
Date PostedSeptember 18, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3218-2026
Recall Event ID 99641
510(K)NumberK161909 
Product Classification Monitor, physiological, patient (without arrhythmia detection or alarms) - Product Code MWI
ProductMidmark 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
Code Information 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
FEI Number 1523530
Recalling Firm/
Manufacturer		 Midmark Corporation
60 Vista Dr
Versailles OH 45380-9488
For Additional Information ContactMidmark Service Operations
844-8561230 Ext. 2
Manufacturer Reason
for Recall		A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
FDA Determined
Cause 2		Process change control
ActionAn Urgent Medical Device Recall notification letter dated 8/19/26 was sent to customers. Safety Instructions Until Midmark provides further instructions regarding this recall, use only the Step Deflation Method when obtaining blood pressure measurements. Do not use the Linear Deflation Method. Follow the instructions in Appendix A to verify that Step Deflation is selected before obtaining blood pressure measurements. Please complete, sign and return the Customer Response Form after completing the instructions described in Appendix A of this notification. The affected device(s) may continue to be used for blood pressure measurements provided this safety instruction is followed. Ensure all users of the affected device(s) are informed of this safety instruction. Product Correction Midmark will contact your facility with the next steps required to complete this recall. Additional instructions will be provided at that time. No immediate action is required to contact Midmark at this time. Contact Information Please be assured that maintaining a high level of safety and quality is our highest priority. If you have any questions, please contact the Technical Service Team at 1.844.856.1230, option 2, or email softwareupdates@midmark.com. Required Distributor Actions 1. Immediately send the attached customer-facing "Urgent Medical Device Recall - IQvitals Zone Linear Deflation Blood Pressure Performance" notification to every impacted end customer to whom you supplied an affected device. Do not wait for Midmark to contact the customer before forwarding the attached safety notification. 2. If you supplied an affected device to another distributor, send that distributor both this first-consignee communication and the attached customer notification. Instruct the downstream distributor to immediately forward only the customer notification to each impacted end customer and provide the final consignee information to you for submission to Midmark. 3. Immediately provide Midmark wi
Quantity in Commerce153 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MWI
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