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Fetal & maternal monitorRecalls & reported problems across all models

Edan Instruments, Inc. · 4 models in the FDA device registry

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names at least one Fetal & maternal monitor 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 4 models of Fetal & maternal monitor by Edan Instruments, Inc. 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

Fetal & maternal monitor 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.

  1. Oct 24, 2025Class IIOpen, Classified

    As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

    Z-1141-2026 · Root cause: Device Design · names 4 of these models · Recall details · FDA record ↗

Fetal & maternal monitor models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

Other Edan Instruments, Inc. products

All Edan Instruments, Inc. devices →

Sources and updates

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