{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-20", "results": { "skip": 0, "limit": 1, "total": 4 } }, "results": [ { "cfres_id": "222051", "product_res_number": "Z-3217-2026", "event_date_initiated": "2026-08-21", "event_date_posted": "2026-09-18", "recall_status": "Open, Classified", "res_event_number": "99641", "product_code": "MWI", "k_numbers": [ "K161909" ], "product_description": "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", "code_info": "Model No: 1-200-0320; UDI-DI: 00841709105791; Kit No: 4-000-0622; UDI-DI: 00841709105876;\n\nKit Serial Number: V2900924;\nZone Serial Number: V2899738", "firm_fei_number": "1523530", "recalling_firm": "Midmark Corporation", "address_1": "60 Vista Dr", "city": "Versailles", "state": "OH", "postal_code": "45380-9488", "additional_info_contact": "Midmark Service Operations\n844-8561230 Ext. 2", "reason_for_recall": "A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.", "root_cause_description": "Process change control", "action": "An Urgent Medical Device Recall notification letter dated 8/19/26 was sent to customers.\n\nSafety Instructions\nUntil 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.\nFollow 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.\nProduct Correction\nMidmark will contact your facility with the next steps required to complete this recall. Additional instructions will be provided at that time.\nNo immediate action is required to contact Midmark at this time.\nContact Information\nPlease 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.\n\nRequired Distributor Actions\n1. 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.\n2. 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.\n3. 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