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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-3220-2026
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: 1-200-0360 with Kit Number: 4-000-0724
Code Information 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 V2868239 V2868840 V2868222 V2866940 V2868892 V2869397 V2867491 V2866963 V2868051 V2923639 V2922999 V2922998 V2923640 V2927201
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 Commerce33 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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