Ventana Medical Systems recall: Navify Digital Pathology
Ventana Medical Systems, Inc. is recalling Navify Digital Pathology – 190. The U.S. Food and Drug Administration published the recall on August 19, 2026; it began on April 20, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | Navify Digital Pathology |
| Brand | Ventana Medical Systems |
| Company | Ventana Medical Systems, Inc. |
| Type | Medical devices |
| Classification | Class II |
| Recall date | April 20, 2026 |
| Published by FDA | August 19, 2026 |
| Quantity | 190 |
| Recall ID | 98998 |
Recalled products
- navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5. Material Number 09453733001 UDI-DI Code: 761333602095AQ In the United States, navify Digital Pathology software (previously known as uPath Enterprise Software) is a component of the Roche Digital Pathology Dx device cleared by the US FDA for Whole Slide Imaging purposes. Roche Digital Pathology Dx is an automated digital slide creation, viewing, and management system.
- FDA recall number
- Z-2913-2026
- Codes, lots and dates
- navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5. Material Number 09453733001 UDI-DI Code: 761333602095AQ Software version Numbers: 2.5.0, 2.5.0.1, 2.5.0.2, and 2.5.1
- Quantity
- 190
- Classification
- Class II
Identifiers and details
- FDA event ID
- 98998
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Tucson, AZ, United States
Why it was recalled
The reason the FDA lists: “Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window”
Where it was sold
Nationwide. Distribution as the FDA records it: “Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OK, PA, PR, SC, SD, TN, TX, UT, WI, and WV. The countries of Austria, Belgium, Czech Republic, France, Germany, Ireland, Italy, Netherlands, Romania, Spain, and Switzerland, Argentina, Bosnia & Herzegovina, Brazil, Chile, Colombia, Dominican Republic, Ecuador, Jordan, Mexico, Myanmar, Peru, Turkey, United Kingdom, Australia, Bahrain, Colombia, Hong Kong, Portugal and India.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 98998, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
Other medical device recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Oct 7, 2026 |  Draeger recall: VentStar Resus NeoMedical devices · 1,063,643 units | Potential cracks in the hose, which could lead to leakage or the hose falling off. Most serious | FDA Class I |
| Oct 7, 2026 | Medline Industries recall: Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories and 1 more productMedical devices · 771,127 total | a fire hazard Most serious | FDA Class I |
| Oct 7, 2026 | Karl Storz Endoscopy recall: HOPKINS Telescope 30¿Medical devices · 6 eyepieces | Due to incorrect inside packaging label for eyepiece. Serious | FDA Class II |
| Oct 7, 2026 | Noxbox recall: NOxBOXi Nitric Oxide Delivery SystemMedical devices · 1,667 units | Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxy… Serious | FDA Class II |
| Oct 7, 2026 | Siemens Healthcare Diagnostics recall: Atellica CH Revised C-Reactive ProteinMedical devices · 42940 units (3938 US, 39002 OUS) | The potential for falsely elevated results. Serious | FDA Class II |
| Oct 7, 2026 | Tandem Diabetes Care recall: T:slim Mobile ApplicationMedical devices · 177 | A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a sof… Serious | FDA Class II |
About this recall
Is Ventana Medical Systems Navify Digital Pathology recalled?
Yes. Ventana Medical Systems, Inc. recalled it on April 20, 2026; FDA published it August 19, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.