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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-3219-2026
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: 1-200-0350 with Kit Number: 4-000-0722
Code Information 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
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 Commerce20 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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