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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

276

Class I (Serious)

242

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 341–360 of 4099 recalls

UroPass Ureteral Access Sheaths (Olympus) – UV Radiation Damage (2024)

Exposure of the UroPass product to Ultraviolet ( UV ) Radiation can cause brittleness of the device dilator tip, which may lead to broken dilator tips in the package or in patients during surgical procedures.

FDASep 11, 2024Nationwide• Olympus Corporation of the Americas

iCast Covered Stent (Atrium) – UDI Label Error (2024)

There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label.

FDASep 9, 2024Nationwide• Atrium Medical Corporation

FLUOROspeed (Shimadzu) – Image Display Issue (2024)

X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy mode to Radiography mode, which may lead to the possibility of delay or cancellation of the examination.

1...16 171819 20...205

Page 18 of 205Next

FDA

Sep 6, 2024

Nationwide

• SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku

Trinias Unity (Shimadzu) – Movement Interference Risk (2024)

If digital angiography system is used with a specific catheterization table and the operator directs simultaneous movement of the table and the C-arm using direct memory, then direct memory button is released, the table may continue to move, which the operator can stop by pressing the stop button.

FDASep 6, 2024Nationwide• SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku

Enterprise Imaging XERO Viewer (Agfa) – Image Placement Bug (2024)

Software defect, when an image has non-square pixel spacing, the reference/localizer line is incorrectly placed on the scout image in the XERO Viewet, may display the incorrect crosshair/line position on the non-coplanar/scout image with respect to the axial slice location. Inaccurate placement of reference lines or crosshairs have potential risk of misdiagnosis or mistreatment due to unintended shifts in the display of anatomical locations.

FDASep 6, 2024Nationwide• Agfa Healthcare NV Septestraat 27 Mortsel Belgium

SONIALVISION G4 (Shimadzu) – Image Display Problem (2024)

FDASep 6, 2024Nationwide• SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku

Olympus Electrosurgical Generator (Olympus) – System Error Risk (2024)

There was an increase in complaints indicating an occurrence of system error E1226 "Could not write to Audio Buffer" during procedures using the ESG-410 (SEP).

FDASep 4, 2024Nationwide• Olympus Corporation of the Americas

AcetaZOLAMIDE Tablets (Rubicon) – Discoloration (2024)

Discoloration

Class IIILow

FDAAug 24, 2024Nationwide• Rubicon Research Private Limited

Endoscopic Flushing Pump (Olympus) – Function Loss Risk (2024)

During product testing, Olympus identified an intermittent loss of function of the OFP-2 Flushing Pump caused by an internal component connection failure.

FDAAug 23, 2024Nationwide• Olympus Corporation of the Americas

Gastrointestinal Videoscope (Olympus) – Color Correction Problem (2024)

It was discovered during device performance testing that the CCD imaging sensors were programmed with the incorrect color correction data and therefore, specifications are not met.

FDAAug 21, 2024Nationwide• Olympus Corporation of the Americas

Varithena Injection Pack (Biocompatibles) – Delivery System Defect (2024)

Defective Delivery System: incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes packaged in the pack, instead of the required silicone oil-free NormJect 10 mL Luer Solo syringes (luer slip connection).

Class IIILow

FDAAug 15, 2024Nationwide• Biocompatibles UK, Ltd.

Soltive Pro Laser (Olympus) - Translation Error (2024)

The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User Interface (GUI), a potential to deliver an incorrect or unintended amount of energy to the patients anatomy.

FDAAug 13, 2024Nationwide• Olympus Corporation of the Americas

Soltive Premium Laser (Olympus) - Translation Error (2024)

FDAAug 13, 2024Nationwide• Olympus Corporation of the Americas

GE Giraffe Warmer (GE HealthCare) - Electrical Safety Gap (2024)

GE HealthCare has become aware that complete electrical safety testing was not conducted during manufacturing of certain Giraffe and Panda iRes Warmers. There are multiple electrical safety protections included in the product design. However, because the electrical safety testing in manufacturing was incomplete for these devices, there is the potential for leakage current to exceed IEC 60601 limits.

FDAAug 9, 2024Nationwide• Wipro GE Healthcare Private Ltd. 122 Part 1 Odyssey And Galileo Bengaluru India

GE Panda iRES Warmer (GE HealthCare) - Electrical Safety Gap (2024)

FDAAug 9, 2024Nationwide• Wipro GE Healthcare Private Ltd. 122 Part 1 Odyssey And Galileo Bengaluru India

Avocado Mattress Pad Protectors (Avocado) – fire hazard (2024)

Fire/Burn Risk

This recall involves Avocado-branded Organic Cotton Mattress Pad Protectors sold in sizes Twin, Twin XL, Full, Queen, King and California King. All sizes were sold in both a Standard Pocket and Deep Pocket version. The quilted, ivory-color mattress pads are made of cotton ticking and cotton fiber fill. Attached to the mattress pad is a law label listing "Model SFMPAVORG", manufacturer name, date of delivery, date of manufacture, fiber content, and washing instructions.

CPSCAug 1, 2024Nationwide• Avocado Mattress LLC, of Mexico

DR 800 X-ray System (Agfa) – Front Lever Chain Failure (2024)

Potential for the front lever chain of the DR 800 table to fail.

FDAJul 29, 2024Nationwide• Agfa N.V. Septestraat 27 Mortsel Belgium

Coconutmilk Chocolate Almond Crunch (Full Circle) – Undeclared Cashews (2024)

Undeclared Allergen

Undeclared cashews. The firm was notified by a customer that the top label and the carton labels do not match. The carton label states, "coconut milk" while the top label states, "cashew milk". The product actually contains the cashew milk product.

Class IIModerate

FDAJul 24, 2024GA, MA, NY• G.S. Gelato and Desserts Inc.

WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC... (Boston Scientific Neuromodulation Corporation) – spinal cord stimulation (scs) implant... (2024)

Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset, which may lead to transient loss of stimulation; patients may experience undesired sensations when therapy turns off for approx. 10-15 seconds and then back on, which may lead patient to request surgical intervention for replacement or revision.

FDAJul 17, 2024Nationwide• Boston Scientific Neuromodulation Corporation

Proton Therapy System (IBA) – Positioning System Issue (2024)

Temporary deactivation of collision detection for Forte Robotic Patient Positioning System occasionally experiences issues

FDAJul 10, 2024IL, LA, MI +6 more• Ion Beam Applications S.A. Chemin Du Cyclotron 3 Ottignies-Louvain-La-Neuve Belgium