Mindray DS USA, Inc. recalls T1 Patient Monitor. Operator's Manual: T1 Patient Monitor
- Recalling company
- Mindray DS USA, Inc.
- Product
- T1 Patient Monitor. Operator's Manual: T1 Patient Monitor
- 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
- 4,946 units
- Lot / codes
- T1 Patient Monitor Operator's Manual: 1. T1 Operator's Manual up to and including revision 14.0; Part No. 046-006734-00
- Company location
- Mahwah, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0116-2027
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0116-2027 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.