Reported Jan 28, 2026 · Ongoing
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description: M3B 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 NumberM3B
- Product DescriptionM3B Vital Signs Monitor is a patient monitoring device providing the patient with a continuous vital physiological monitoring of arterial blood oxygen saturation (SpO2), Pulse Rate and CO2 in a hospital, hospital type facilities environment and intra-hospital moves
- ComponentNo
- Lot codes and dates
- EDAN ModelM3B
- UDI-DI code06944413800625
- Serial/Lot Numbers
354 of 354 codes
302135-M16304900001302135-M16304900002261184-K17400190004261184-K17400190001261184-K17400190006261184-K17400190002261184-K17400190005261184-K17400190003261184-M17A03040001261184-M18502370001360126-M18810390001360126-M18A08360001360126-M18B13740001360126-M19302070001360126-M19302070002360126-M19302070004360126-M19302070003360126-M20310110001360126-M20310110002360126-M20507230004360126-M20507230003360126-M20507230002360126-M20507230001360126-M20507230010360126-M20507230007360126-M20507230006360126-M20507230008360126-M20507230009360126-M20507230005360126-M23226940004360126-M23226940005360126-M23226940003360126-M23226940001360126-M23226940002360126-M24511420002360126-M24511420001360126-M24716380001360126-M24716380002360126-M24716380003360126-M24716380004360126-M24716380005302135-M16403060001302135-M16403060002302135-M16403060003302135-M16403060004302135-M16901880001302135-M16901880002302135-M16901880003360126-M19805440001360126-M19805440002360126-M19805440003360126-M19805440004360126-M20A13020002360126-M20A13020001360126-M20C18100001360126-M21113380001360126-M21404350001360126-K23100140005360126-K23100140004360126-K23100140006
- Amount recalled
- 354
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.
Want the full recall guide?
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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