Class III recall Z-0109-2027: Mindray DS USA, Inc.
Class III recall Z-0109-2027: Mindray DS USA, Inc. (New Jersey): Mindray DS USA, Inc. Dated 21 days ago, it is in the active follow-up window. Score 46/100. 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: 17 related NJ FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0109-2027 |
| Recalling firm | Mindray DS USA, Inc. |
| Classification | Class III |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A |
| Reason | Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions |
| Quantity | 32,184 units |
| Distribution | Worldwide - Nationwide and the country of Canada. |
| Recall initiated | 2026-08-31 |
| Reported | 2026-10-14 |
| Firm location | Mahwah, NJ, United States |
| Peer records CSV (18 NJ records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-14
- 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 III recall Z-0109-2027: Mindray DS USA, Inc. and 18 New Jersey peers
- New Jersey FDAPulse records like this one: 18
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every New Jersey peer: $3,600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
46 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Class III recall: lower risk.
- Recall is still ongoing.
- Posted 21 days ago.
What is the FDAPulse record for Class III recall Z-0109-2027: Mindray DS USA, Inc. in New Jersey?
Class III device recall Z-0109-2027 by Mindray DS USA, Inc.: Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding
How does Class III recall Z-0109-2027: Mindray DS USA, Inc. compare to other New Jersey FDAPulse records?
It is 21 days old, still within a typical 45-day follow-up window.
Class III recall Z-0109-2027 vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Class III recall Z-0109-2027 | NJ | 2026-10-14 |
| Class III recall Z-0110-2027 | NJ | 2026-10-14 |
| Class III recall Z-0112-2027 | NJ | 2026-10-14 |
| Class III recall Z-0111-2027 | NJ | 2026-10-14 |
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