Class II recall Z-3219-2026: Midmark Corporation
Class II recall Z-3219-2026: Midmark Corporation (Ohio): Midmark Corporation. Dated 35 days ago, it serves as a historical benchmark. Score 62/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Free preview: all 14 published fields of this record are shown below. Locked: 24 related OH FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-3219-2026 |
| Recalling firm | Midmark Corporation |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| 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: 1-200-0350 with Kit Number: 4-000-0722 |
| Reason | A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used. |
| Quantity | 20 units |
| Distribution | US Nationwide distribution. |
| Recall initiated | 2026-08-21 |
| Reported | 2026-09-30 |
| Firm location | Versailles, OH, United States |
| Peer records CSV (25 OH records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-09-30
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: Class II recall Z-3219-2026: Midmark Corporation and 25 Ohio peers
- Ohio FDAPulse records like this one: 25
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Ohio peer: $5,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
62 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 35 days ago.
What is the FDAPulse record for Class II recall Z-3219-2026: Midmark Corporation in Ohio?
Class II device recall Z-3219-2026 by Midmark Corporation: A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
How does Class II recall Z-3219-2026: Midmark Corporation compare to other Ohio FDAPulse records?
It is 35 days old, still within a typical 45-day follow-up window.
Class II recall Z-3219-2026 vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Class II recall Z-3219-2026 | OH | 2026-09-30 |
| Class II recall Z-3155-2026 | MA | 2026-10-07 |
| Class II recall Z-0232-2027 | 2026-10-28 | |
| Class II recall Z-0243-2027 | 2026-10-28 |
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