ePM Series Patient Monitor Recall
ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A
What is the FDA recall status?
The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.
Why was ePM Series Patient Monitor recalled?
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Which lot codes, UPCs or models are affected?
Part numbers of ePM Series Patient Monitors Operator's Manuals: 1. Guardian Plus Operator's Manual (OEM, MDPro) up to and including revision 4.0; Part No. 046-026408-00 2. ePM 10A Operator's Manual up to and including revision 12.0; Part No. 046-019796-00 3. ePM 12MA Operator's Manual up to and including revision 13.0; Part No. 046-019797-00 4. ePM 10M, ePM 12M Operator's Manual up to and including revision 13.0; Part No. 046-019798-00 5. ePM 15M Operator's Manual up to and including revision 3.0; Part No. 046-028915-00
- Agency record number
- Z-0109-2027
- Product
- ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A
- Recalling firm
- Mindray DS USA, Inc.
- Quantity
- 32,184 units
- Distribution
- Worldwide - Nationwide and the country of Canada.
- Recall started
- August 31, 2026
- Report date
- October 14, 2026
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (device)