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Olympus Corporation of the Americas

Olympus Corporation of the Americas Recalls

All product recalls associated with Olympus Corporation of the Americas.

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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 3281–3300 of 17593 recalls

EVIS EXERA III Colonovideoscope (Olympus) – Procedure Misuse (2022)

A single CF-Q180AL colonovideoscope was utilized in a veterinary endoscopy procedure in advance of being assigned to a medical facility as a service loaner in error, potential for microbial contamination

Low

FDADec 21, 2022Nationwide• Olympus Corporation of the Americas

Cobas Influenza Test (Roche) – False Negative Risk (2022)

The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. A false negative influenza A result may lead to additional testing, psychological distress, and delays to targeted therapy for influenza as well as true diagnosis.

High

FDADec 21, 2022Nationwide• Roche Molecular Systems, Inc.

Cobas SARS-CoV-2 Test (Roche) – False Negative Risk (2022)

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High

FDADec 21, 2022Nationwide• Roche Molecular Systems, Inc.

Alsultan Sweets Betefour (Falcon Import) – Undeclared Nuts (2022)

Undeclared Allergen

Undeclared cashews, almonds, and pistachios

Class IIModerate

FDADec 20, 2022Nationwide• FALCON IMPORT & EXPORT LLC

Alsultan Sweets Mixed Baklava (Falcon Import) – Undeclared Allergens (2022)

Undeclared Milk

Undeclared milk and wheat

Class IIModerate

FDADec 20, 2022Nationwide• FALCON IMPORT & EXPORT LLC

GE Nuclear Medicine System (GE) – Detector Fall Risk (2022)

A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.

Very High

FDADec 19, 2022Nationwide• GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel

Biostop G Cement Restrictor (Depuy) – Endotoxin Level Risk (2022)

All lots of BIOSTOP G Bioresorbable Cement Restrictor are being removed as a precautionary measure because tested endotoxin levels were higher than recommended by the current FDA regulatory guidance. In general, endotoxins have a potential to initiate inflammatory responses, ranging from a mild fever to potentially impact or damage to vital organs.

Moderate

FDADec 19, 2022Nationwide• Depuy Ireland UC Loughbeg, Ringaskiddy Co. Cork Munster Ireland

ScanWatch (Withings) – ECG Activation Bug (2022)

A software bug eliminated the initial ECG activation and review of the ECG under a physician. However, the device is only cleared for use under the care of a physician.

Low

FDADec 19, 2022Nationwide• Withings 37 Bis Rue Du General Leclerc Issy les Moulineaux CEDEX France