Passport Series Patient Monitor: recall status

Notice names this product. Mindray DS USA’s Passport Series Patient Monitor is named in FDA Class III recall Z-0114-2027. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions Identifying details: Part Numbers of Passport Series Patient Monitor Operator's Manuals: 1. Passport 8_12 Operator's Manual up to and including revision 13.0; Part No. 046-004417-00 2. Passport 17M 12M Operator's Manual up to and including revision 17.0; Part No. 046-005013-00 3. Passport V Patient Monitors Operating Instructions up to and including revision 10.0; Part No. 0070-00-0704-02. Units affected: 39,891 units. Status: Ongoing.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: Passport Series Patient Monitor
Company / brand: Mindray DS USA
Lot / serial / date codes: Part Numbers of Passport Series Patient Monitor Operator's Manuals: 1. Passport 8_12 Operator's Manual up to and including revision 13.0; Part No. 046-004417-00 2. Passport 17M 12M Operator's Manual up to and including revision 17.0; Part No. 046-005013-00 3. Passport V Patient Monitors Operating Instructions up to and including revision 10.0; Part No. 0070-00-0704-02
Distribution: Worldwide - Nationwide and the country of Canada.

Agency product description and boundaries

Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / V

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

Brand: Mindray DS USA

Recalls naming this model

FDA Class III · Medical device · October 14, 2026

Passport Series Patient Monitor recall — Mindray DS USA, Inc.

Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions

Company / brand: Mindray DS USA recalls

Affected product: Passport Series Patient Monitor recall status

Official ID Z-0114-2027 · Official record ↗

See all Mindray DS USA recalls →

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 12:00 PM UTC.