Reported Jan 28, 2026 · Ongoing
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: elite V5, elite V6, elite V8 Product Description:…
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 NamePatient
- Monitor Model/Catalog Number
elite V5elite V6
- elite V8 Product DescriptionV series Patient Monitor including elite V5, elite V6 and elite V8 which can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time. The V series Patient Monitor realize the monitoring of physiological parameters by configuration with different parameter modules which include SpO2 (pulse oxygen saturation, pulse rate and SpO2 plethysmogram) with EDAN SpO2 module or Nellcor SPO2 module, NIBP (systolic pressure, diastolic pressure, mean pressure and pulse rate), TEMP, ECG, RESP(respiration), CO2, IBP, C.O. and AG(anesthetic gas), RM(respiratory mechanics), BIS(bispectral index) and ICG(impedance cardiography)
- ComponentNo
- Lot codes and dates
- EDAN Modelelite
- V8 UDI-DI code06944413801707
- Serial/Lot Numbers
260342-M17B09290001002338-M23226990001002338-M23226990002002338-M23226990004002338-M23226990003002338-M23812870001002338-M23C15870001002338-M24A12130001260342-M16506570001260342-M15A03180001002338-K22100150003002338-K22100150004002338-K22100150002002338-K22100150001261241-M22701020001002338-M25705810020002338-M25705810021002338-M25705810011002338-M25705810003002338-M25705810013002338-M25705810029002338-M25705810033002338-M25705810001002338-M25705810010002338-M25705810009002338-M25705810004002338-M25705810012002338-M25705810018002338-M25705810032002338-M25705810017002338-M25705810019002338-M25705810024002338-M25705810030002338-M25705810031002338-M25705810025002338-M25705810016002338-M25705810008002338-M25705810006002338-M25705810002002338-M25705810028002338-M25705810027002338-M25705810022002338-M25705810026002338-M25705810023002338-M25705810015002338-M25705810014002338-M25705810005002338-M25705810007002338-M25908680004002338-M25908680003002338-M25908680002002338-M25908680001
- EDAN Modelelite
- V5 UDI-DI code06944413802155
- Serial/Lot Numbers
274 of 274 codes
260586-M17211520002260586-M17211520006260586-M17211520004260586-M17211520008260586-M17211520001260586-M17211520009260586-M17211520007260586-M17211520003260586-M17211520010260586-M17211520005260588-M17902120009260588-M17902120002260588-M17902120008260588-M17902120001260588-M17902120003260588-M17902120006260588-M17902120007260588-M17902120004260588-M17902120005260588-M17902120010260586-M19413090016260586-M19413090007260586-M19413090017260586-M19413090006260586-M19413090010260586-M19413090014260586-M19413090011260586-M19413090008260586-M19413090004260586-M19413090019260586-M19413090012260586-M19413090003260586-M19413090013260586-M19413090009260586-M19413090005260586-M19413090002260586-M19413090018260586-M19413090001260586-M19413090020260586-M19413090015260586-M19507110023260586-M19507110013260586-M19507110005260586-M19507110009260586-M19507110004260586-M19507110019260586-M19507110018260586-M19507110024260586-M19507110003260586-M19507110008260586-M19507110020260586-M19507110014260586-M19507110001260586-M19507110002260586-M19507110016260586-M19507110010260586-M19507110011260586-M19507110012260586-M19507110015260586-M19507110021
- EDAN Modelelite
- V6 UDI-DI code06944413802162
- Serial/Lot Numbers
260598-M17409030001260597-M18402870001260597-M23613650001260598-M17207680001260597-M17211510002260597-M17211510001260597-M20B20220001260597-M23515100001260597-M24803380006260597-M24803380005260597-M24803380002260597-M24803380001260597-M24803380004260597-M24803380003260597-M21816200001260597-M25315990001
- Amount recalled
- 342
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.
Free recall alerts
Get alerted about new Edan Diagnostics recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.