Recall Z-3219-2026

Reason for recall

A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.

FDA-determined cause: Process change control

Action taken

An 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