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Ventana Medical Systems Inc

Ventana Medical Systems Inc Recalls

All product recalls associated with Ventana Medical Systems Inc.

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Recall Summary

Total Recalls

1000

Past Year

579

Class I (Serious)

Most Recent

Dec 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 2661–2680 of 10937 recalls

BenchMark Ultra Instruments (Ventana) – Fluid Leak Risk (2022)

Fire/Burn Risk

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.

High

FDAJan 20, 2022AL, AK, AZ +49 more• Ventana Medical Systems Inc

YelloPort Elite Trocar (Surgical Innovations) – Sterility Labeling (2022)

Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile.

Low

FDAJan 20, 2022MA• Surgical Innovations Ltd 6 Clayton Wood Bank Lds Leeds United Kingdom

Sight OLO Blood Analysis Device (Sight Diagnostics) – Reference Range Issue (2022)

In instances where custom reference ranges were configured on the device post installation, a possibility to inadvertently apply changes to reference range values was found on software versions 2.59.3 and all earlier versions, which can potentially lead to displaying and printing incorrectly-configured reference range values

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Low

FDAJan 20, 2022Nationwide• SIGHT DIAGNOSTICS LTD 23, Derekh Menakhem Begin Tel Aviv-Yafo Israel

YelloPort Plus Cannula (Surgical Innovations) – Sterility Labeling (2022)

Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile.

Low

FDAJan 20, 2022MA• Surgical Innovations Ltd 6 Clayton Wood Bank Lds Leeds United Kingdom

FRIGG Silicone Pacifiers (FRIGG) – choking hazard (2022)

Choking Hazard

The FRIGG silicone pacifiers came in two designs: Classic and Daisy. The Classic design consists of a silicone nipple attached to a round plastic shield. The Daisy design consists of a silicone nipple attached to a round scalloped plastic shield. Each design came in two sizes: 0-6 months and 6-18 months. The name "FRIGG" appears in raised letters on the handle of the pacifier shield. The FRIGG silicone pacifiers were sold in over 40 colors.

High

CPSCJan 19, 2022Nationwide• FRIGG Production ApS / FB Trading ApS, of Denmark

LINQ II Cardiac Monitor (Medtronic) – Moisture Ingress Risk (2022)

Devices may lose functionality due to susceptibility to moisture ingress.

Low

FDAJan 18, 2022Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Merete PediatrOS RigidTack (Merete) – Label Mismatch (2022)

Incorrect marketing label (25 mm) was applied to product size 20 mm.

Low

FDAJan 18, 2022IL• Merete Medical GmbH Alt-Lankwitz 102 Berlin Germany

Del(5q) FISH Probe Kit (Cytocell) – Color Labeling Error (2022)

individual components have been labelled with incorrect colours. The red and green colours are opposite to those specified in the product labelling. The EGR1 probe is labelled in green rather than red and the control probe labelled in red rather than green. The expected positive signal pattern in the case of 1x deleted 5q will be 1G2R instead of 1R2G, an incorrect result

Low

FDAJan 18, 2022Nationwide• Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom

EGL and ACE Youth ATVs (Yongkang Jiayue) – injury risk (2022)

Laceration Risk

The recall involves EGL and ACE branded Youth ATVs, models MADIX 125 and D110. The name of the vehicle is printed on a label located on both sides of the vehicle. The model number is stamped into the metal plate located on the left side, under the rear body. The ATVs were sold as either Age 12+ or Age 16+. The ATVs have a label under the model number, stating: "This ATV is subject to EGL MOTOR INC's action plan approved by U.S. Consumer Product Safety Commission."

Very High

CPSCJan 12, 2022Nationwide• Yongkang Jiayue Industry & Trading Co., Ltd., of China (model D110)

Inclinator Residential Elevators (Inclinator) – child entrapment (2022)

This recall involves Inclinator residential elevators manufactured from 1979 through 2021. Models include: Winding Drum (450 - 1,000 lb.), Hydraulic Drive, Chain Drive, Traction Drive and Overhead Cable Drum. Serial numbers are located on the elevator controllers, stamped on the rails, or on the outside of the drum for Winding Drum units. The elevators are used in consumers' homes.

Very High

CPSCJan 11, 2022Nationwide• Inclinator Company of America Inc., of Harrisburg, Pa.

SonialVision G4 X-Ray System (Shimadzu) – Radiation Dose Issue (2022)

It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to inadequate adjusting criteria in installation.

High

FDAJan 10, 2022AK, AZ, AR +34 more• Shimadzu Medical Systems

SonialVision Safire17 X-Ray (Shimadzu) – Radiation Dose Issue (2022)

High

FDAJan 10, 2022AK, AZ, AR +34 more• Shimadzu Medical Systems

FLUOROspeed X1 X-Ray System (Shimadzu) – Radiation Dose Issue (2022)

High

FDAJan 10, 2022AK, AZ, AR +34 more• Shimadzu Medical Systems

NavitrackER Knee Kit (Zimmer) – Sterilization Concern (2022)

The product was released for distribution without passing sterilization results, which could potentially lead to insufficient sterility of the product. The highest severity risk is infection leading to surgical intervention.

High

FDAJan 7, 2022Nationwide• Orthosoft, Inc. dba Zimmer CAS 3300-75 Queen St Montreal Canada

BD Vacutainer Luer Lok Device (Becton Dickinson) – Specimen Contamination (2022)

May shed contaminant particles into the urine specimen that may be misidentified as Red Blood Cells when used in conjunction with the Sysmex UF-1000i or UX-2000 Analyzers and lead to false elevations in RBC counts

Moderate

FDAJan 6, 2022Nationwide• Becton Dickinson & Company

Metoprolol Tablets (Rubicon Research) – Metal Embedded (2021)

Complaint received of foreign matter (metal) embedded in tablet.

Class IIModerate

FDADec 31, 2021Nationwide• Rubicon Research Private Limited

RayStation/RayPlan (RaySearch Labs) – Image Set Display Problem (2021)

If a new primary image set is selected while the cine loop is running, the primary image set will be displayed as both primary and secondary image set in all side-by-side views. This will also be true for any new patient or case opened while the cine loop is running

Low

FDADec 30, 2021Nationwide• RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden

MEDPOR Titan OFW (Stryker) – Manufacturing Defect (2021)

Inside the packaging of one reported item a non-conforming product was found. Contrary to the design, the barrier layer was manufactured on the inferior side of the implant versus the superior side.

Low

FDADec 29, 2021Nationwide• Stryker Leibinger GmbH & Co. KG Botzinger Str. 41 Freiburg Im Breisgau Germany

Frozen Tuna Steaks (Relish Foods) – histamine levels (2021)

Elevated levels of histamines found in FDA consumer samples of frozen tuna steaks.

Class IIModerate

FDADec 28, 2021CA• Relish Foods, Inc. dba Gourmet Fusion Foods

NIM TRIVANTAGE EMG Tube (Medtronic) – Manufacturing Issue (2021)

There is potential for multiple issues due to a manufacturing nonconformity.

High

FDADec 22, 2021Nationwide• Medtronic Xomed, Inc.