DM4Recalls & reported problems across all models
Zoe Medical Incorporated · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one DM4 model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 8 models of DM4 by Zoe Medical Incorporated in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
DM4 recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 13, 2024Open, Classified
This product labeling does not adequately provide warning about the risks associated with the use of damaged batteries or batteries past the intended use life.
Z-3099-2024 · Root cause: Labeling design · names 8 of these models · Recall details · FDA record ↗
DM4 models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- DM4 91331-NMonitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)1 recall0 reports
- DM4 91331-NFMonitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)1 recall0 reports
- DM4 91331-NWMonitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)1 recall0 reports
- DM4 91331-NFWMonitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)1 recall0 reports
- DM4 91331-MMonitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)1 recall0 reports
- DM4 91331-MFMonitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)1 recall0 reports
- DM4 91331-MWMonitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)1 recall0 reports
- DM4 91331-MFWMonitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)1 recall0 reports
Other Zoe Medical Incorporated products
All Zoe Medical Incorporated devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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