Brand Name: EDAN Product Name: Central Monitoring System… — Class II medical device recall Z-1150-2026
Ongoing recall by Edan Diagnostics, reported 2026-01-28, distributed nationwide. As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybers
| Recall number | Z-1150-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edan Diagnostics, San Diego, CA, United States |
| Recall initiated | 2025-10-24 |
| Classified | 2026-01-22 |
| Reported by FDA | 2026-01-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | MX |
| Quantity | 195 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 06944413800229, 06944413814264 |
| Lot numbers | 114M2330484, 114M2370760, 114M23B0232, 261432-M18310890001, 261432-M18312480001, 261432-M18400410002, 261432-M18401960001, 261432-M18501600001, 261432-M18802330001, 261432-M18803430001, 261432-M18B04070001, 261432-M18B04070002, 261432-M18C06730001, 261432-M18C06730002, 261432-M18C06730003, 261432-M18C06730004, 261432-M18C06730005, 261432-M18C06730006, 261432-M19402160001, 261432-M19402160002, 261432-M19402160003, 261432-M19912390001, 261432-M19A10370007, 261432-M19B02530001, 261432-M19B02530002, 261432-M19B02530003, 261432-M19B02530005, 261432-M19B02530006, 261432-M20213550001, 261432-M20213550002, 261432-M20213550003, 261432-M20213550004, 261432-M20213550005, 261432-M20213550006, 261432-M20412240001, 261432-M20702060001, 261432-M20702060002, 261432-M20702060004, 261432-M20702060005, 261432-M20702060006 and 117 more |
Product
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1150-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.