Recall Z-1152-2026
Edan Diagnostics · initiated October 24, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description: M3B 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. Component: No
Codes / lots: EDAN Model: M3B UDI-DI code: 06944413800625 Serial/Lot Numbers: 302135-M16304900001 302135-M16304900002 261184-K17400190004 261184-K17400190001 261184-K17400190006 261184-K17400190002 261184-K17400190005 261184-K17400190003 261184-M17A03040001 261184-M18502370001 360126-M18810390001 360126-M18A08360001 360126-M18B13740001 360126-M19302070001 360126-M19302070002 360126-M19302070004 360126-M19302070003 360126-M20310110001 360126-M20310110002 360126-M20507230004 360126-M20507230003 360126-M20507230002 360126-M20507230001 360126-M20507230010 360126-M20507230007 360126-M20507230006 360126-M20507230008 360126-M20507230009 360126-M20507230005 360126-M23226940004 360126-M23226940005 360126-M23226940003 360126-M23226940001 360126-M23226940002 360126-M24511420002 360126-M24511420001 360126-M24716380001 360126-M24716380002 360126-M24716380003 360126-M24716380004 360126-M24716380005 302135-M16403060001 302135-M16403060002 302135-M16403060003 302135-M16403060004 302135-M16901880001 302135-M16901880002 302135-M16901880003 360126-M19805440001 360126-M19805440002 360126-M19805440003 360126-M19805440004 360126-M20A13020002 360126-M20A13020001 360126-M20C18100001 360126-M21113380001…
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.
FDA-determined cause: Device Design
Action taken
On 10/24/2025, the firm emailed notifying customers of a product recall. On 11/06/2025, the firm emailed an "URGENT: MEDICAL DEVICE CORRECTION" Letter to customers informing them of labeling issues involving cybersecurity which arose from a communication from the U.S. Food & Drug Administration. -First issue involves an inappropriate publicly routable IP address that was used as an example in the user manual for demonstrating user-configurable IP settings and Second issue involves an inappropriate publicly IP address that was used as the factory default configuration. Customer are instructed to: 1. Immediately examine their inventory and quarantine product subject to correction. 2. If customers may have further distributed affected product, identify their customers and notify them at once of this product correction. The notification to their customers may be enhanced by including the enclosed URGENT MEDICAL DEVICE CORRECTION. 3. For affected product still in their inventory, place copy of the enclosed Notice Before Use and Corrigenda of User Manual into its package before distribution. 4. For affected product that has been distributed or is in use: (1) Confirm that they have received and acknowledged Corrigenda of User Manual. Print out a copy, attach to the User Manual. (2) Confirm the publicly routable IP address 202.114.4.* is NOT used in the User Maintain in the device. If 202.114.4.* is being used, change to appropriate IP settings of device in the Network Setup according to Instruction Instructions for IP Settings Configuration. 5. Complete the attached Acknowledgement and Receipt Form, sign it, and return a scanned copy to the sender of this notification by email. For questions - Contact: EDAN Instruments, Inc. Monday to Friday 09:00-17:00 (UTC+8) Tel:+86-0755-26898326 EDAN Diagnostics, Inc. Monday to Friday 09:00-17:00 (PST) Tel: 1-(858)-750-3066
Details
- Recall number
- Z-1152-2026
- Initiated
- October 24, 2025
- Posted by FDA
- January 22, 2026
- Product code
- DQA – Oximeter
- Quantity
- 354
- Distribution
- 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.
- Recalling firm
- Edan Diagnostics, San Diego, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1140-2026 Class II | Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product…As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential… | 10/24/2025Open, Classified |
| Z-1141-2026 Class II | Brand Name: EDAN Product Name: Fetal & Maternal Monitor Model/Catalog Number: F6, F9, F6…As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential… | 10/24/2025Open, Classified |
| Z-1142-2026 Class II | Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product…As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential… | 10/24/2025Open, Classified |
| Z-1143-2026 Class II | Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product…As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential… | 10/24/2025Open, Classified |
| Z-1144-2026 Class II | Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3s, iM3As…As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential… | 10/24/2025Open, Classified |
| Z-1145-2026 Class II | Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM50, iM60, iM70…As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential… | 10/24/2025Open, Classified |
| Z-1146-2026 Class II | Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: elite V5, elite V6…As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential… | 10/24/2025Open, Classified |
| Z-1147-2026 Class II | Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM20 Product…As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential… | 10/24/2025Open, Classified |
| Z-1148-2026 Class II | Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: X8, X10, X12…As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential… | 10/24/2025Open, Classified |
| Z-1149-2026 Class II | Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX12, iX15…As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential… | 10/24/2025Open, Classified |
| Z-1150-2026 Class II | Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CMS…As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential… | 10/24/2025Open, Classified |
| Z-1151-2026 Class II | Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CNS…As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential… | 10/24/2025Open, Classified |
| Z-1153-2026 Class II | Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3A Product…As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential… | 10/24/2025Open, Classified |
| Z-1154-2026 Class II | Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM8, iM8A, iM8B…As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential… | 10/24/2025Open, Classified |
| Z-1155-2026 Class II | Brand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog Number: iT20 Product…As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential… | 10/24/2025Open, Classified |