Ventana Medical Systems, Inc. recalls
Every recall we track for Ventana Medical Systems, Inc. — 39 in all, from 2017–2026 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Ventana Medical Systems, Inc. peaked in 2018 (21); 39 since 2017.
All FDA recall records for Ventana Medical Systems, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 1 | 11 | 0 | 12 |
| 2018 | 0 | 0 | 21 | 0 | 21 |
| 2019 | 0 | 1 | 0 | 0 | 1 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 2 | 1 | 0 | 3 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 1 | 0 | 1 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 1 | 0 | 1 |
What to do if you have a recalled Ventana Medical Systems, Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Ventana Medical Systems, Inc. recalls
8 shown- Lower riskMedical device
Ventana Medical Systems, Inc. recalls navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5. Material
Ventana recalls navify Digital Pathology v2.5 software versions due to image/metadata discrepancies in Viewer window. Affected users should contact Ventana for details.
VentanaApr 20, 2026 - Lower riskMedical device
Ventana Medical Systems, Inc. recalls Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD
Ventana recalls anti-CD10 (SP67) Rabbit Monoclonal Antibody REF 790-4506 due to potential false positives in lab tests. Affected units have specific UDI codes.
VentanaJun 27, 2024 - Lower riskMedical device
Ventana Medical Systems, Inc. recalls VENTANA PD-L1 (SP142) VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 07709374001 VENTANA PD-L1 (SP142) Assay (CE IVD
Ventana Medical Systems recalls PD-L1 (SP142) assays due to light staining causing potential false-negative results in cancer testing. Affected units have specific UDI-DI codes.
VentanaNov 18, 2022 - Use cautionMedical device
Ventana Medical Systems Inc recalls Ventana HE 600 System, automated slide preparer, for use in laboratories.
Ventana Medical Systems recalls HE 600 lab slide preparer due to potential fluid leaks causing electrical shorts and fire. All units are affected.
VentanaJun 1, 2022 - Use cautionMedical device
Ventana Medical Systems Inc recalls BenchMark ULTRA and DISCOVERY ULTRA Instruments
Ventana Medical Systems recalls BenchMark Ultra and Discovery Ultra instruments with serial numbers <= 322030 due to potential fluid leaks causing electrical shorts and fire risks.
Ventana Medical SystemsJan 20, 2022 - Use cautionMedical device
Ventana Medical Systems Inc recalls Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System s intended use environment includes anatomic
Ventana Medical Systems recalls HE 600 histology instruments with model 06917259001 due to cleaning solution leaking into electrical wiring, risking burned components in lab settings.
VentanaOct 4, 2019 - Lower riskMedical device
Ventana Medical Systems Inc recalls INFORM HPV III Fam 16 Probe - US Export, Catalog Number 05278856001, model 800-4295 Immunohistochemistry (IHC) for in
Ventana recalls HPV III Fam 16 Probe (model 800-4295) due to risk of false negative immunohistochemistry results from leaking reagent dispensers. Affected units sold in US with specific catalog number and lot.
VentanaAug 2, 2018 - Lower riskMedical device
Ventana Medical Systems Inc recalls ultraView Universal DAB Detection Kit, Ventana part Number 760-500, Roche GMMI 05269806001 in vitro diagnostic
Ventana recalls ultraView Universal DAB Detection Kit (part 760-500) due to leaking and sticking reagent dispensers. Affected units have specific lot numbers and UDI codes. Stop using immediately to prevent potential contamination.
VentanaDec 19, 2017
Ventana Medical Systems, Inc. recall questions
How many recalls has Ventana Medical Systems, Inc. had?
39 recalls from Ventana Medical Systems, Inc. are on record with U.S. safety agencies, from 2017–2026.
What is the most recent Ventana Medical Systems, Inc. recall?
Ventana Medical Systems, Inc. recalls navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5. Material, dated Apr 20, 2026. Every Ventana Medical Systems, Inc. recall is listed on this page, newest first.
What should I do if I have a recalled Ventana Medical Systems, Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Ventana Medical Systems, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.