Recall Z-3218-2026 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Midmark Corporation
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: 1-200-03300 with Kit Number: 4-000-0624
| Date | Sep 18, 2026 (initiated Aug 21, 2026) |
| Status | Open, Classified |
| Reason | A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used. |
| Root cause | Process change control |
| Action | 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 |
| Quantity | 153 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161909 | IQvitals Zone Midmark Corporation, Nov 17, 2016 |