Reported Jan 28, 2026 · Ongoing
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product Description: The Vital Signs…
Edan Diagnostics
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Edan Diagnostics · 9833 Pacific Heights Blvd · San Diego, CA · 92121-4707
Is this the product you have?
- Brand NameEDAN
- Product NameVital
- Signs Monitor Model/Catalog NumberM3
- Product DescriptionThe Vital Signs Monitor is a portable device intended for use by health care professionals. The monitor could provide the monitoring of physiological parameters such as the non-invasive blood pressure (NIBP), the oxygen saturation of the blood (SpO2) and Rectal/Oral/Auxiliary/Ear temperature measurement
- ComponentNo
- Lot codes and dates
- EDAN ModelM3
- UDI-DI code06944413800618
- Serial/Lot Number
1,627 of 1,627 codes
302050-M16200560001302050-M16200560002302089-M16203830017302089-M16203830006302089-M16203830020302127-M15B11010006302127-M16203840001302127-M16203840002302127-M16203840003302127-M16203840004302127-M16203840005302127-M16203840006302127-M16203840007302127-M16203840008302127-M16203840009302127-M16203840010302127-M16203840011302127-M16203840012302127-M16203840013302127-M16203840014302089-M16203830019302089-M16203830018302089-M16203830016302089-M16203830015302089-M16203830014302089-M16203830013302089-M16203830012302089-M16203830011302089-M16203830010302089-M16203830008302089-M16203830007302089-M16203830005302089-M16203830004302089-M16203830009302050-M16203850007302089-M16203830003302050-M16203850001302089-M16203830002302089-M16203830001302050-M16203850010302050-M16203850009302050-M16203850008302050-M16203850002302050-M16203850006302050-M16203850005302050-M16203850004302050-M16203850003302050-M16407160008302050-M16407160007302050-M16407160006302050-M16407160005302050-M16407160004302050-M16407160003302050-M16407160002302050-M16407160001302050-M16407160009302050-M16407160010302127-M16407150005302127-M16407150004302127-M16407150003
- Amount recalled
- 13934
This recall covers 16 products
The agency filed one notice per product. You are reading one of them; the other 15 are below.
3 more are in the archive.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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