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Edan Diagnostics FDA Recalls
16 recalls on file across devices, 0 of them Class I and 16 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
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| Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3A Product Description: The Vital Signs MonClass IIOct 24, 2025As a result of receiving an FDA It Has Come to Our Attention |
| Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX12, iX15 Product Description: The iX serClass IIOct 24, 2025As a result of receiving an FDA It Has Come to Our Attention |
| Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: elite V5, elite V6, elite V8 Product DescriptionClass IIOct 24, 2025As a result of receiving an FDA It Has Come to Our Attention |
| Brand Name: EDAN Product Name: Fetal & Maternal Monitor Model/Catalog Number: F6, F9, F6 Express, F9 Express Product Class IIOct 24, 2025As a result of receiving an FDA It Has Come to Our Attention |
| Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM20 Product Description: The iM20 Patient MonitClass IIOct 24, 2025As a result of receiving an FDA It Has Come to Our Attention |
| Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product Description: The devices are bedsidClass IIOct 24, 2025As a result of receiving an FDA It Has Come to Our Attention |
| Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CMS Product Description: MFM-CMS iClass IIOct 24, 2025As a result of receiving an FDA It Has Come to Our Attention |
| Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product Description: The Vital Signs MoniClass IIOct 24, 2025As a result of receiving an FDA It Has Come to Our Attention |
| Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CNS, MFM-CNS Lite Product DescriptClass IIOct 24, 2025As a result of receiving an FDA It Has Come to Our Attention |
| Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM8, iM8A, iM8B Product Description: iM8 Series Class IIOct 24, 2025As a result of receiving an FDA It Has Come to Our Attention |
| Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product Description: The iM3 has three wClass IIOct 24, 2025As a result of receiving an FDA It Has Come to Our Attention |
| Brand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog Number: iT20 Product Description: iT20 collects phClass IIOct 24, 2025As a result of receiving an FDA It Has Come to Our Attention |
| Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description: M3B Vital Signs MonClass IIOct 24, 2025As a result of receiving an FDA It Has Come to Our Attention |
| Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3s, iM3As, iM3Bs, iHM3s Product DescriptioClass IIOct 24, 2025As a result of receiving an FDA It Has Come to Our Attention |
| Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM50, iM60, iM70, iM80 Product Description: The Class IIOct 24, 2025As a result of receiving an FDA It Has Come to Our Attention |
| Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: X8, X10, X12 Product Description: The X8 X10 X12Class IIOct 24, 2025As a result of receiving an FDA It Has Come to Our Attention |