FDA Device recall Z-3218-2026
Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal),…
- FDA Device
- Class II
- ongoing
- Published 2026-09-30
On 2026-09-30 the FDA classified a Class II recall of Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal),… by Midmark, citing A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3218-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-21 |
| Published | 2026-09-30 |
| Last updated | 2026-10-06 05:30 UTC |
| Company | Midmark |
| Distribution | US |
Product
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
Reason
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
Identifiers
| code_info | Model No: 1-200-0330; UDI-DI: 00841709105807; Kit No: 4-000-0624; UDI-DI: 00841709105883; Kit Serial Number: V2842901…Model No: 1-200-0330; UDI-DI: 00841709105807; Kit No: 4-000-0624; UDI-DI: 00841709105883; Kit Serial Number: V2842901 V2841713 V2841724 V2842133 V2842105 V2841750 V2841701 V2842116 V2842081 V2842097 V2866067 V2871822 V2871211 V2871204 V2871817 V2881636 V2878754 V2878741 V2878759 V2879975 V2879979 V2879564 V2880715 V2880713 V2881270 V2880698 V2880711 V2879544 V2881253 V2882161 V2881704 V2882141 V2881259 V2881258 V2881698 V2881677 V2881684 V2879566 V2882146 V2879551 V2877649 V2877655 V2877673 V2880021 V2878308 V2878306 V2878734 V2877678 V2878299 V2878294 V2880023 V2875958 V2875328 V2877119 V2877065 V2874409 V2877114 V2874415 V2875941 V2875331 V2876441 V2876423 V2874794 V2874786 V2877057 V2877131 V2873684 V2876410 V2876449 V2873677 V2876455 V2888858 V2896346 V2897752 V2896689 V2897157 V2895863 V2899478 V2898923 V2896355 V2898561 V2896708 V2897134 V2896352 V2898573 V2895879 V2899469 V2895878 V2899455 V2898942 V2898200 V2896720 V2898188 V2898192 V2898563 V2898930 V2897759 V2897764 V2897128 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-06 05:30 UTC. Current status: ongoing.
Other recalls by Midmark
- Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal),…
FDA Device · Class II · 2026-09-30 · Midmark - Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal),…
FDA Device · Class II · 2026-09-30 · Midmark - Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal),…
FDA Device · Class II · 2026-09-30 · Midmark - Midmark IQecg Digital ECG, Model/Catalog Number: 4-000-0061, 4-000-0062 Software Version: Midmark IQecg Plugin versions starting with v10 a…
FDA Device · Class II · 2026-09-02 · Midmark - Midmark Digital ECG HD+12, HD+15, Model/Catalog Number: 4-000-0080 Software Version: Midmark IQecg Plugin versions starting with v10 and pr…
FDA Device · Class II · 2026-09-02 · Midmark
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3218-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.