RecallReported October 14, 2026
Class III recall by Mindray DS USA, Inc.
ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A
FDA's enforcement report of October 14, 2026 lists a Class III recall by Mindray DS USA, Inc. of Mahwah, NJ. Product: ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A. Status: Ongoing.
On the record
- Recalling firm
- Mindray DS USA, Inc.
- Location
- Mahwah, NJ
- Classification
- Class III
- Status
- Ongoing
- Recall number
- Z-0109-2027
- Product type
- Devices
- Recall initiated
- 2026-08-31
- Reported by FDA
- 2026-10-14
The full record
An account shows the reason for the recall, where the product was distributed and the lots.
What a recall is
FDA classifies a recall by the hazard. Class I: a reasonable probability that the product will cause serious adverse health consequences or death. Class II: the product may cause temporary or medically reversible harm, or the probability of serious harm is remote. Class III: the product is not likely to cause adverse health consequences.
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From FDA enforcement reports. The record may have changed since it was read.
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