CLASS II ONGOING Device recall · Reported 28 Jan 2026 · FDA Enforcement Report
EDAN Central Monitoring System recalled by Edan Diagnostics
Edan Diagnostics is recalling EDAN Central Monitoring System, distributed nationwide in the US. The recall was initiated on 24 Oct 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1150-2026
- FDA event ID
- 97879
- Recalling firm
- Edan Diagnostics, San Diego, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Oct 2025
- FDA classified
- 22 Jan 2026
- Reported
- 28 Jan 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Patient Monitors
Timeline
| 24 Oct 2025 | Recall initiated by company | |
| 22 Jan 2026 | Classified by FDA | +90 days |
| 28 Jan 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CMS Product Description: MFM-CMS is a central monitoring system product, which can connect and manage information from EDAN medical devices. MFM-CMS offers central management for monitoring information from the medical devices. All these collected information can be displayed, printed, alarmed and recorded. Component: No
Where it was distributed
Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the country of Mexico.
Nationwide CaliforniaConnecticutFloridaIllinoisKentuckyLouisianaMichiganNorth CarolinaNew YorkPennsylvaniaPuerto RicoRhode IslandTexas
Questions about this recall
Why was it 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.
Which lots are affected?
EDAN Model: MFM-CMS UDI-DI code: 06944413800229 Serial/Lot Numbers: 261432-M18312480001 261432-M18803430001 261432-M18B04070001 261432-M18B04070002 261432-M18C06730001 261432-M18C06730002 261432-M18C06730004 261432-M18C06730003 261432-M18C06730005 261432-M18C06730006 261432-M19402160001 261432-M19402160003 261432-M19402160002 261432-M19B02530001 261432-M19B02530006 261432-M19A10370007 261432-M19B02530005 261432-M19B02530003 261432-M19B02530002 261432-M20213550006 261432-M20213550005 261432-M20213550003 261432-M20213550002 261432-M20213550004 261432-M20213550001 261432-M20702060001 261432-M20702060006 261432-M20702060002 261432-M20702060004 261432-M20702060007 261432-M20702060005 261432-M20708340003 261432-M20708340005 261432-M20708340002 261432-M20708340004 261432-M20708340001 261432-M20708340006 261432-M20810650003 261432-M20810650004 261432-M20810650002 261432-M20810650001 261432-M20810650006 261432-M20810650005 261432-M18401960001 261432-M20C04930001 261432-M20C04930002 261432-M20C04930005 261432-M20C04930004 261432-M20C04930003 261432-M20C04930006 261432-M21111490005 261432-M21111490004 261432-M21111490003 261432-M21111490002 261432-M21111490006 261432-M21111490001 261432-M21206490002 261432-M21206490006 261432-M21206490001 261432-M21206490005 261432-M21206490004 261432-M21206490003 261432-M21409870005 261432-M21409870003 261432-M21409870004 261432-M21409870001 261432-M21409870002 261432-M21409870006 261432-M21509140001 261432-M21509140003 261432-M21509140005 261432-M21509140004 261432-M21509140006 261432-M21509140002 261432-M21706970007 261432-M21706970008 261432-M21706970005 261432-M21706970001 261432-M21706970004 261432-M21706970006 261432-M21809930002 261432-M21909020003 261432-M21909020004 261432-M21909020002 261432-M21810820020 261432-M21810820006 261432-M21810820003 261432-M21809930005 261432-M21809930004 261432-M21809930003 261432-M21809930001 261432-M21909020001 261432-M18400410002 261432-M18310890001 261432-M18501600001 261432-M18802330001 261432-M19912390001 261432-M20412240001 261432-M20708340007 261432-M20915430001 261432-M20B09110001 261432-M20B13840001 261432-M20C10170001 261432-M21204410002 261432-M21204410003 261432-M21204410004 261432-M21204410001 261432-M21306400002 261432-M21306400003 261432-M21306400001 261432-M21316340001 261432-M21404840001 261432-M21512920002 261432-M21512920001 261432-M21615470001 261432-M21702760001 114M2330484 114M2330484 114M2330484 114M2330484 114M2330484 114M2330484 114M2330484 114M2370760 114M2370760 114M2370760 114M2370760 114M2370760 114M2370760 114M2370760 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1625 267M23B1625 267M23B1625 267M23B1625 267M23B1625 267M23B1625 267M23B1625 114M23B0232 114M23B0232 114M23B0232 114M23B0232 114M23B0232 114M23B0232 114M23B0232 114M23B0232 EDAN Model: MFM-CMS UDI-DI code: 06944413814264 Serial/Lot Numbers: 262237-M24611330012 262237-M24611330001 262237-M24611330011 262237-M24611330014 262237-M24611330009 262237-M24611330019 262237-M24611330004 262237-M24611330008 262237-M24611330007 262237-M24611330017 262237-M24611330010 262237-M24611330003 262237-M24611330005 262237-M24611330015 262237-M24611330013 262237-M24611330018 262237-M24611330002 262237-M24611330006 262237-M24611330016 262237-M24814380001 262237-M24905030001 262237-M24C17400001 262237-M24C17400003 262237-M24C17400004 262237-M24C17400002 262237-M24C17400005 MRM-CMSIII 262237-M24B06940008 262237-M24B06940001 262237-M24B06940003 262237-M24B06940005 262237-M24B06940010 262237-M24B06940004 262237-M24B06940007 262237-M24B06940006 262237-M24B06940002 262237-M24B06940009
Where was it sold?
Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the country of Mexico.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
8 other products · FDA event 97879This product is part of a recall event; the main page for the event is EDAN Central Monitoring System recalled by Edan Diagnostics.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | EDAN Central Monitoring System recalled by Edan Diagnostics | Edan Diagnostics | Device Malfunction | Nationwide | |
| CLASS II | EDAN Telemetry Transmitter recalled by Edan Diagnostics | Edan Diagnostics | Device Malfunction | Nationwide | |
| CLASS II | EDAN Patient Monitor recalled by Edan Diagnostics | Edan Diagnostics | Device Malfunction | Nationwide | |
| CLASS II | EDAN Patient Monitor recalled by Edan Diagnostics | Edan Diagnostics | Device Malfunction | Nationwide | |
| CLASS II | EDAN Patient Monitor recalled by Edan Diagnostics | Edan Diagnostics | Device Malfunction | Nationwide | |
| CLASS II | EDAN Vital Signs Monitor recalled by Edan Diagnostics | Edan Diagnostics | Other | Nationwide | |
| CLASS II | EDAN Vital Signs Monitor recalled by Edan Diagnostics | Edan Diagnostics | Other | Nationwide | |
| CLASS II | EDAN Patient Monitor recalled by Edan Diagnostics | Edan Diagnostics | Temperature Abuse | Nationwide |
More recalls from Edan Diagnostics
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | EDAN Patient Monitor recalled by Edan Diagnostics | Edan Diagnostics | Temperature Abuse | Nationwide |
| Device | CLASS II | EDAN Vital Signs Monitor recalled by Edan Diagnostics | Edan Diagnostics | Other | Nationwide |
| Device | CLASS II | EDAN Vital Signs Monitor recalled by Edan Diagnostics | Edan Diagnostics | Other | Nationwide |
| Device | CLASS II | EDAN Patient Monitor recalled by Edan Diagnostics | Edan Diagnostics | Device Malfunction | Nationwide |
| Device | CLASS II | EDAN Patient Monitor recalled by Edan Diagnostics | Edan Diagnostics | Device Malfunction | Nationwide |
Other Patient Monitors recalls
All 1,022| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | Passport Series Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | T1 Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | cPM Series Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | BeneVision Series Telemetry Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | Panorama and Telemetry Monitoring System recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |