Reported Oct 14, 2026 · Ongoing · Updated Oct 20, 2026
ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A
Mindray DS USA, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mindray DS USA, Inc. · 800 Macarthur Blvd · Mahwah, NJ · 07430-2001
Is this the product you have?
- ePM Series Patient Monitor
- Patient Monitor SeriesePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A
- Lot codes and dates
5 of 5 products
Products covered by this recall Model / number Product as published 046-026408-00Guardian Plus Operator's Manual (OEM, MDPro) up to and including revision 4.0 046-019796-00ePM 10A Operator's Manual up to and including revision 12.0 046-019797-00ePM 12MA Operator's Manual up to and including revision 13.0 046-019798-00ePM 10M, ePM 12M Operator's Manual up to and including revision 13.0 046-028915-00ePM 15M Operator's Manual up to and including revision 3.0 - Amount recalled
- 32,184 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
Why it was recalled
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Mindray DS USA, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.