Browse Device Recalls

18 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 18 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 18 FDA device recalls.

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DateProductReasonClassFirm
Oct 24, 2025 Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM20 ... As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... Class II Edan Diagnostics
Oct 24, 2025 Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM50, ... As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... Class II Edan Diagnostics
Oct 24, 2025 Brand Name: EDAN Product Name: Fetal & Maternal Monitor Model/Catalog Numbe... As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... Class II Edan Diagnostics
Oct 24, 2025 Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: X8, X1... As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... Class II Edan Diagnostics
Oct 24, 2025 Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Numb... As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... Class II Edan Diagnostics
Oct 24, 2025 Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM... As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... Class II Edan Diagnostics
Oct 24, 2025 Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM... As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... Class II Edan Diagnostics
Oct 24, 2025 Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3... As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... Class II Edan Diagnostics
Oct 24, 2025 Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3... As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... Class II Edan Diagnostics
Oct 24, 2025 Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3... As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... Class II Edan Diagnostics
Oct 24, 2025 Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM8, i... As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... Class II Edan Diagnostics
Oct 24, 2025 Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: elite ... As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... Class II Edan Diagnostics
Oct 24, 2025 Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, ... As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... Class II Edan Diagnostics
Oct 24, 2025 Brand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog Number: ... As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... Class II Edan Diagnostics
Oct 24, 2025 Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Numb... As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... Class II Edan Diagnostics
Oct 24, 2025 Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 ... As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... Class II Edan Diagnostics
Nov 17, 2017 EDAN Telemetry Transmitter, Model iT20 - Product Usage: The iT20 telemetry tr... Firm became aware that it distributed 7 units in the U.S. that included a function that had not b... Class II Edan Diagnostics
Jun 23, 2016 EtCO2 Module -Part Number: 02.01.210699 Monitors: iM80, iM50, M50, iM70, iM60... Incorrect CO2 readings with some patient monitors. Class II Edan Diagnostics

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.