Mindray DS USA, Inc. recalls Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / V
- Recalling company
- Mindray DS USA, Inc.
- 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
- Classification
- Class III – not likely to cause adverse health consequences
- Recall date
- Aug 31, 2026
- Reported
- Oct 14, 2026
- Distribution
- Worldwide - Nationwide and the country of Canada.
- Status
- Ongoing
- Quantity
- 39,891 units
- Lot / 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
- Company location
- Mahwah, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0114-2027
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0114-2027 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.