Ventana Medical Systems, Inc. recalls navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5. Material Number…
Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window
Read the official notice →- Date
- 2026-08-19
- Country
- United States
- Brand
- Ventana Medical Systems
- Product
- navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5. Material Number 09453733001…
- Classification
- Class II
- Units
- Worldwide - U.S. Nationwide distribution including in the states of AL, AR,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Ventana Medical Systems recalls
- 2024-08-28
USVentana Medical Systems, Inc. recalls Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD
Their is a potential for high background and off-target staining when using the monoclonal primary antibody which can result in false positive results.
FDA · DeviceVentana Medical Systems, Inc.Worldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice →- 2023-01-18
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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 Predictive)…
Internal comparison studies revealed unacceptable, light staining. Light staining affects the borderline of positive versus negative test results. It can cause a reduction in both staining intensity and the percent…
FDA · DeviceVentana Medical Systems, Inc.Worldwide distribution - U.S. Nationwide distribution including in the states…Official notice → - 2022-07-20
- US
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There is a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical short and fire
FDA · DeviceVentana Medical Systems IncUS: AL AR AZ CA CO CT DC FL GA HI IA IL IN KS KY MA MD MI MN MO MS MT NC NE NJ…Official notice → - 2022-04-13
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Ventana Medical Systems Inc recalls BenchMark ULTRA and DISCOVERY ULTRA Instruments
Potential for Fluid Leak inside a staining system that could cause an electrical short circuit of the General Purpose Input/ Output Board's J1 Connector that could result in smoke and fire.
FDA · DeviceVentana Medical Systems IncUS: CA, IL, PA, FL, AZ, NY, OH, CO, AR, NC, MD, AL, AK, LA, IA, MN, MA, ND,…Official notice →
Other drugs & medical recalls in the United States
- 2026-08-19
- US
Galt Medical Corporation recalls Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-03) Sheath with Dilator , Stiffen Dilator,…
Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits.
- US
Spacelabs Healthcare, Inc. recalls Brand Name: Xhibit Product Name: Xhibit Central Station Model/Catalog Number: 96102 Software Version: N/A Product Description: The…
Due to off-the-shelf display port component that has audio/video failures
FDA · DeviceSpacelabs Healthcare, Inc.Worldwide - US Nationwide distribution in the states of AK, AL, AR, AZ, CA,…Official notice → - US
W L Gore & Associates, Inc. recalls GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to maintain…
10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).
FDA · DeviceW L Gore & Associates, Inc.U.S. Nationwide distribution in the states of GA and RI.Official notice → - US
MICROVENTION INC. recalls BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US MV-BGA01095 For use in facilitating the insertion and…
Due to an increase rate of balloon pinhole defects.
FDA · DeviceMICROVENTION INC.Worldwide - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, FL,…Official notice → - US
Spectra Medical Devices, Llc recalls Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalog Number:…
Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter. This…
FDA · DeviceSpectra Medical Devices, LlcDistributed in the United States to medical device kit packers in six (6)…Official notice → - US
Baxter Healthcare Corporation recalls Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration Sets
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