# Class III recall Z-0114-2027: Mindray DS USA, Inc.

**Predicate Speed & CAPA Advisory Opportunity Score:** 46/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0114-2027 |
| Recalling firm | Mindray DS USA, Inc. |
| Classification | Class III |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / V |
| Reason | Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions |
| Quantity | 39,891 units |
| Distribution | Worldwide - Nationwide and the country of Canada. |
| Recall initiated | 2026-08-31 |
| Reported | 2026-10-14 |
| Firm location | Mahwah, NJ, United States |

## Why this score
- Class III recall: lower risk.
- Recall is still ongoing.
- Posted 22 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0114-2027%22). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.