Recall company profile

Edan Diagnostics Recalls

Overview of recall records associated with Edan Diagnostics, including dates, categories and classifications where available.

16recall records
Jan 28, 2026latest record date
Jan 28, 2026earliest record date

Recall history in this database

Classification mix: Class II: 16.

Medical DeviceJan 28, 2026

EDAN Fetal Monitor recall — FDA Z-1140-2026

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.

Class IIFDA: OngoingEdan Diagnostics
Medical DeviceJan 28, 2026

EDAN Vital Signs Monitor recall — FDA Z-1142-2026

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.

Class IIFDA: OngoingEdan Diagnostics
Medical DeviceJan 28, 2026

EDAN Vital Signs Monitor recall — FDA Z-1153-2026

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.

Class IIFDA: OngoingEdan Diagnostics
Medical DeviceJan 28, 2026

EDAN Telemetry Transmitter recall — FDA Z-1155-2026

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.

Class IIFDA: OngoingEdan Diagnostics
Medical DeviceJan 28, 2026

EDAN Patient Monitor recall — FDA Z-1149-2026

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.

Class IIFDA: OngoingEdan Diagnostics
Medical DeviceJan 28, 2026

EDAN Patient Monitor recall — FDA Z-1146-2026

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.

Class IIFDA: OngoingEdan Diagnostics
Medical DeviceJan 28, 2026

EDAN Patient Monitor recall — FDA Z-1154-2026

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.

Class IIFDA: OngoingEdan Diagnostics
Medical DeviceJan 28, 2026

EDAN Vital Signs Monitor recall — FDA Z-1143-2026

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.

Class IIFDA: OngoingEdan Diagnostics
Medical DeviceJan 28, 2026

EDAN Vital Signs Monitor recall — FDA Z-1152-2026

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.

Class IIFDA: OngoingEdan Diagnostics
Medical DeviceJan 28, 2026

EDAN Vital Signs Monitor recall — FDA Z-1144-2026

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.

Class IIFDA: OngoingEdan Diagnostics
Medical DeviceJan 28, 2026

EDAN Patient Monitor recall — FDA Z-1148-2026

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.

Class IIFDA: OngoingEdan Diagnostics
Medical DeviceJan 28, 2026

EDAN Patient Monitor recall — FDA Z-1145-2026

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.

Class IIFDA: OngoingEdan Diagnostics
Medical DeviceJan 28, 2026

EDAN Patient Monitor recall — FDA Z-1147-2026

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.

Class IIFDA: OngoingEdan Diagnostics

Understanding this recall history

This page summarizes recall records in which the official source identifies Edan Diagnostics as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.

Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.