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Leica Microsystems, Inc.

Leica Microsystems, Inc. Recalls

All product recalls associated with Leica Microsystems, Inc..

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Recall Summary

Total Recalls

1000

Past Year

891

Class I (Serious)

124

Most Recent

Jan 2026

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 3361–3380 of 17593 recalls

M530 OHX Microscope (Leica) – Power Supply Overheat (2022)

There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Consequently, due to the overstressing of the internal components, one specific component can fail which will cause the device to unexpectedly shutdown.

High

FDANov 21, 2022Nationwide• Leica Microsystems, Inc.

Ventana PD-L1 Assay (Ventana) – Light Staining Issue (2022)

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 positivity, which could potentially lead to a false-negative PD-L1 result.

Moderate

FDANov 18, 2022Nationwide• Ventana Medical Systems, Inc.

IRISpec Control (Beckman Coulter) – False Positive Results (2022)

Beckman Coulter has become aware of an increase in customer complaints generated for intermittent IRISpec CB glucose control false positive results when used in conjunction with iChemVelocity Urine Chemistry Strips PN 800-7212

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Low

FDANov 18, 2022PR• Beckman Coulter, Inc.

Coach Phoenix (Coach and Equipment) – Fuel Line Risk (2022)

Fire/Burn Risk

Coach and Equipment Mfg, Corp. (Coach and Equipment) is recalling certain 2016-2023 Phoenix transit buses equipped with Roush fuel return lines included in GEN 4 and GEN 5 LPG Conversion Systems that were installed on vehicles sold or registered in Connecticut, Delaware, Illinois, Indiana, Iowa, Kentucky, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Vermont, Virginia, Washington D.C., West Virginia, and Wisconsin. The zinc-plating on the fuel return line may break away when contacted by road debris, causing two dissimilar metals on the fuel line to contact each other and corrode.

High

NHTSANov 18, 2022Nationwide• COACH AND EQUIPMENT

Electrosurgical Suction Coagulator (ConMed) – Suction Port Occlusion (2022)

Suction ports may potentially be occluded on the affected devices. If this occurs, the affected devices will not be able to perform the suction function during use, which could cause a delay in procedure and could require another device to be used.

High

FDANov 18, 2022Nationwide• ConMed Corporation

MATRYX, AXYS, Pro-Ride Snowmobiles (Polaris) – Fire Hazard (2022)

Fire/Burn Risk

This recall involves Polaris Model Years 2021 through 2023 MATRYX, model years 2015 through 2022 AXYS, and certain 2013 and 2014 Pro-Ride snowmobiles. The recalled snowmobiles were sold in black and in custom color combinations. Polaris and the model names are printed on the chassis on both sides of the snowmobiles. The model year and VIN are stamped on the right side of the tunnel. Consumers can enter their VIN at www.polaris.com/en-us/off-road-recalls/ to see if their snowmobile is included in any recalls.

High

CPSCNov 17, 2022Nationwide• Polaris Industries Inc., of Medina, Minnesota

B125M Patient Monitor (GE Medical) – CO2 Measurement Error (2022)

GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate when used in a location that is not at or near sea level.

Moderate

FDANov 16, 2022Nationwide• GE Medical Systems, LLC

iTotal Identity Impactor Handle (Conformis) – Screw Loosening (2022)

Loctite thread locker (epoxy) may not have been applied to the screw that is part of the handle. In the absence of epoxy, the screw may loosen and fall into the patient during a procedure.

High

FDANov 14, 2022Nationwide• Conformis, Inc.

Sodium Sulfacetamide Cleansing Pads (Acella) – Subpotent Drug (2022)

Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period.

Class IIILow

FDANov 14, 2022Nationwide• Acella Pharmaceuticals, LLC

Phenytoin Sodium Injection (Acella) – Missing Barcode (2022)

Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.

Class IIILow

FDANov 14, 2022Nationwide• Acella Pharmaceuticals, LLC

Phenytoin Sodium Injection (Acella) – Missing Barcode (2022)

Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.

Class IIILow

FDANov 14, 2022Nationwide• Acella Pharmaceuticals, LLC

Sardines in Tomato Sauce (St. Jean's) - High Histamine Levels (2022)

Canned sardines in tomato sauce recalled due to high levels of histamine.

Class IIModerate

FDANov 11, 2022AZ, CA, ID +4 more• St. Jean's Coast Mountain Resources Ltd. (dba) St. Jean's Ca

Vivid q Ultrasound (GE Medical) – Battery Failure (2022)

Fire/Burn Risk

Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

Moderate

FDANov 10, 2022Nationwide• GE Medical Systems, LLC

Vivid S5 Ultrasound (GE Medical) – Battery Failure (2022)

Fire/Burn Risk

Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

Moderate

FDANov 10, 2022Nationwide• GE Medical Systems, LLC

Portable Generators (Generac) - Amputation Risk (2022)

This recall involves 6500-watt and 8000-watt Generac portable generators with unit type numbers XT8000E XT8000EFI, GP6500, GP6500E, GP8000E and HomeLink 6500E portable generators, and DR models PRO 6500M and PRO 6500E portable generators. This recall also involves all of these generators listed above purchased after July 29, 2021 through November 3, 2022, containing a repair kit which included full cover handle guards. The generators have gasoline-powered engines that are used to generate electricity for use as backup power. The portable generators have two-wheels and a single, U-shaped, two-grip, flip-up pin-lock handle to help move the generator. Only the following generators are included in this recall. The unit type is identified on the front of the product. The model and serial numbers are printed on a label on the product. Consumers can also check specific unit type, model number, and serial number location information at www.generac.com/service-support/product-support-lookup. Unit Type Model Number First Serial Number Last Serial Number XT8000E G0064330 G0064331 3000037849 3005569372 G0064340 G0064342 XT8000EFI G0071620 G0071621 3003336356 3006597843 G0071621R GP6500 G0076720 G0076800 G0076800R G0076812 G0076830 G0076830R G0076902 G0076902R G0076903 GP6500E G0076820 G0076820R G0076822 GP8000E G0076731 G0076751 G0076751R G0076761 G0076761R G0076861 G0076861R PRO 6500M GP16505DMN GP16505DMNR PRO 6500E GP16505DEN HomeLink 6500E G0068650 G0068651 G0079960

Moderate

CPSCNov 10, 2022Nationwide• Generac Power Systems, of Waukesha, Wisconsin

Vivid q N Ultrasound (GE Medical) – Battery Failure (2022)

Fire/Burn Risk

Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

Moderate

FDANov 10, 2022Nationwide• GE Medical Systems, LLC

Vivid S5 N Ultrasound (GE Medical) – Battery Failure (2022)

Fire/Burn Risk

Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

Moderate

FDANov 10, 2022Nationwide• GE Medical Systems, LLC

Stay Informed

Leica Microsystems, Inc. Recalls

Recall Summary

M530 OHX Microscope (Leica) – Power Supply Overheat (2022)

Ventana PD-L1 Assay (Ventana) – Light Staining Issue (2022)

IRISpec Control (Beckman Coulter) – False Positive Results (2022)

Coach Phoenix (Coach and Equipment) – Fuel Line Risk (2022)

Electrosurgical Suction Coagulator (ConMed) – Suction Port Occlusion (2022)

MATRYX, AXYS, Pro-Ride Snowmobiles (Polaris) – Fire Hazard (2022)

B125M Patient Monitor (GE Medical) – CO2 Measurement Error (2022)

B105P Patient Monitor (GE Medical) – CO2 Measurement Error (2022)

B125P Patient Monitor (GE Medical) – CO2 Measurement Error (2022)

B105M Patient Monitor (GE Medical) – CO2 Measurement Error (2022)

iTotal Identity Impactor Handle (Conformis) – Screw Loosening (2022)

Sodium Sulfacetamide Cleansing Pads (Acella) – Subpotent Drug (2022)

Phenytoin Sodium Injection (Acella) – Missing Barcode (2022)

Phenytoin Sodium Injection (Acella) – Missing Barcode (2022)

Sardines in Tomato Sauce (St. Jean's) - High Histamine Levels (2022)

Vivid q Ultrasound (GE Medical) – Battery Failure (2022)

Vivid S5 Ultrasound (GE Medical) – Battery Failure (2022)

Portable Generators (Generac) - Amputation Risk (2022)

Vivid q N Ultrasound (GE Medical) – Battery Failure (2022)

Vivid S5 N Ultrasound (GE Medical) – Battery Failure (2022)