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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

1000

Class I (Serious)

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 4501–4520 of 21320 recalls

Rotatable Clip Device (Olympus) - Procedure Failure (2023)

There have been complaints that the clip did not come out of the tube sheath during the procedure.

Moderate

FDAFeb 23, 2023Nationwide• Olympus Corporation of the Americas

Metformin Extended-Release (Teva) – NDMA contamination (2023)

CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.

Class IIModerate

FDAFeb 22, 2023CA• Teva Pharmaceuticals USA Inc

2D Perfusion (Philips) - Signal Processing (2023)

There are technical issues related to signal generation and processing, which can lead to inaccurate presentations.

Moderate

FDA

1...224 225226227 228...1066

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Feb 20, 2023

Nationwide

• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

SmartPerfusion (Philips) - Signal Processing (2023)

There are technical issues related to signal generation and processing, which can lead to inaccurate presentations.

Moderate

FDAFeb 20, 2023Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Gabapentin Tablets (Sciegen) – tablet mix-up (2023)

Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles.

Class IIILow

FDAFeb 17, 2023Nationwide• Sciegen Pharmaceuticals Inc

Electric Bicycles (Linus Bike) – Crash hazard (2023)

This recall involves the Linus Bike Cesta 500 and Ero 500 electric bicycles. The serial number can be found on the underside of the frame near the chain ring. The brand name "Linus" is printed on the frame of the bicycle. The recalled bicycles have one of the following serial numbers. Product Name Serial Number Ero500/Cesta500 LXD20100231-LXD20100420 Ero500/Cesta500 LXD20100686- LXD20100830 Ero500/Cesta500 LXD20100956- LXD20101060

Moderate

CPSCFeb 16, 2023Nationwide• Shenzhen Xidesheng Bicycle Co Ltd, of China

Thermage CPT System (Solta Medical) - Calibration Problem (2023)

A service unit was potentially improperly tested and calibrated during manufacturing on a failed test station.

Moderate

FDAFeb 16, 2023MD• Solta Medical Inc

ElectraMeccanica Solo G3 (ElectraMeccanica) - Inverter Defect (2023)

Electra Meccanica Vehicles Corp (Electra) is recalling certain 2019 Solo G2 and 2021-2023 Solo G3 vehicles. A defect in the motor controller and inverter or the battery controller may cause the electric motor to shut down and cause a sudden loss of drive power.

Moderate

NHTSAFeb 16, 2023Nationwide• ELECTRAMECCANICA

Infinity Occipitocervical Screw (Medtronic) - Material Strength (2023)

Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws

Moderate

FDAFeb 16, 2023Nationwide• Medtronic Sofamor Danek USA Inc

Sheetz Ham Deli Sandwich – Undeclared sesame (2023)

Undeclared Allergen

Product may contain undeclared sesame

Class IIModerate

FDAFeb 16, 2023IN, MD, NC +4 more• Sheetz Distribution Services, L.L.C.

Sheetz Turkey Deli Sandwich – Undeclared sesame (2023)

Undeclared Allergen

Product may contain undeclared sesame.

Class IIModerate

FDAFeb 16, 2023IN, MD, NC +4 more• Sheetz Distribution Services, L.L.C.

Flex-Neck Catheter Kit (Merit) - Unintended Distribution (2023)

Product that was built for design verification testing was inadvertently distributed to customers.

Moderate

FDAFeb 15, 2023Nationwide• Merit Medical Systems, Inc.

Attune Posterior Tibial Insert (DePuy) - Irradiation Dosage (2023)

The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.

Moderate

FDAFeb 15, 2023Nationwide• DePuy Orthopaedics, Inc.

Attune Revision Tibial Insert (DePuy) - Irradiation Dosage (2023)

Moderate

FDAFeb 15, 2023Nationwide• DePuy Orthopaedics, Inc.

FoundationOne CDx (Foundation Medicine) - Claim Error (2023)

An incorrect negative claim was identified on the claims page; the device variant information was displayed correctly in the tumor profiling section of the FDA-approved test report.

Moderate

FDAFeb 15, 2023Nationwide• Foundation Medicine, Inc.