Reported Jan 28, 2026 · Ongoing
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM50, iM60, iM70, iM80 Product Description: The iM…
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
iM50iM60iM70
- iM80 Product DescriptionThe iM series Patient Monitor including iM50, iM60, iM70 and iM80 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 abnormalities so that doctors and nurses can respond to the patient's situation as appropriate
- ComponentNo
- Lot codes and dates
- EDAN ModeliM50
- UDI-DI code06944413801622
- Serial/Lot Numbers
1,627 of 1,627 codes
002327-M16803350001002327-M16803350002360069-M17707110001333109-M16203920004333109-M16203920005333136-M16203910001333136-M16203910002333136-M16203910003333136-M16203910004333136-M16203910006333136-M16203910007333136-M16203910008333136-M16203910009333136-M16203910010333136-M16203910005333109-M16203920003333109-M16203920002333109-M16203920001333109-M16802350004333109-M16802350005333109-M16802350006333109-M16802350007333109-M16802350008333136-M16802360001333136-M16802360002333136-M16802360003333136-M16802360004333109-M16802350003333136-M16802360005333109-M16802350002333109-M16802350001333136-M16810700002333136-M16810700003333136-M16810700004333136-M16810700005333136-M16810700001333136-M16A02590001333136-M16A02590002333136-M16A02590005333136-M16A02590004333136-M16A02590003333136-M16A02590006333136-M16A02590007333136-M16A02590008333136-M16A02590009333136-M16A02590010333136-M16B08530006333136-M16B08530011333136-M16B08530010333136-M16B08530009333136-M16B08530008333136-M16B08530007333136-M16B08530014333136-M16B08530005333136-M16B08530004333136-M16B08530003333136-M16B08530002333136-M16B08530001333109-M16B08540003333109-M16B08540002
- Amount recalled
- 14550
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.