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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 1761–1780 of 21319 recalls

EZDilate Wire Guided Balloon (Olympus) – Mislabeled Size Concern (2024)

Mislabeled Glo Cath Label (attached to the device) states: 11 mm, 12 mm, 13 mm however the balloon is 8.5mm, 9.5mm and 10.5 mm and may result in prolonged surgery. All other labeling is correct for the balloon, including the Shelf Box with Front Box Label and Circular Star Label and the balloon Pouch

Low

FDASep 13, 2024CA, DE, FL +8 more• Olympus Corporation of the Americas

Z-800 Infusion System (Zyno Medical) – Air-in-Line Software Defect (2024)

There is a defect in the air-in-line software algorithm.

Moderate

FDASep 13, 2024Nationwide• Zyno Medical LLC

Olympus Cystoscope Outer Sheath (Olympus) – Compatibility Statement Removal (2024)

Olympus is removing the statement of compatibility with a GreenLight Laser for BPH therapy from the Instruction for Use (IFU) due to the potential for a damaged tip during use of a laser probe.

Moderate

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FDASep 13, 2024Nationwide• Olympus Corporation of the Americas

Enjoy Premium Coconut Cookies (KTM Services) – Undeclared Milk (2024)

Undeclared Allergen

Undeclared allergens; milk

Class IHigh

FDASep 13, 2024HI, IN, NV• KTM Services, Inc.

Enjoy Premium Taro Cookies (KTM Services) – Undeclared Milk (2024)

Undeclared Allergen

Undeclared allergens; milk

Class IHigh

FDASep 13, 2024HI, IN, NV• KTM Services, Inc.

BD Synapsys (Becton Dickinson) – Software Error (2024)

Synapsys software versions 4.20, 4.30, 5.10, 5.20, or 5.30 and utilizing the in-line breakpoint feature, an error is occurring where BD Synapsys will incorrectly display breakpoints for organisms that do not have defined breakpoints in CLSI or EUCAST. This occurs when the identified organism is included in the same interpretive group as a species for which there is a specific breakpoint. May result in either a false susceptible or false resistant result. A false susceptible result can cause inadequate or incomplete antibiotic treatment due to the use of an ineffective antibiotic, and a false resistant result may limit access to a preferred antibiotic regimen with possible elongation of therapy

Moderate

FDASep 12, 2024Nationwide• Becton Dickinson & Co.

Cadet Apex72 Electric Heaters (Glen Dimplex) – Potential Fire Risk (2024)

Fire/Burn Risk

This recall involves Glen Dimplex Americas' Cadet-branded Apex72 high wall electric heaters between 1200 and 1600 Watts. The fan-forced heaters have a white dust cover and are installed into walls a minimum of six feet off the ground. "Cadet," the model number, and the manufacturing date in DD-MM-YY format appear on the rating label visible through the bottom of the air outlet grill. The following models and manufacturing dates are included in this recall: Models Manufacturing Dates HW128 01-Mar-21 through 29-Feb-24 HW132 01-Mar-21 through 29-Feb-24 HW151 01-Mar-21 through 29-Feb-24 HW162 any date older than 01-Mar-24 HW162BP5 any date older than 01-Mar-24 HW168 any date older than 01-Mar-24 HW168BP5 any date older than 01-Mar-24

High

CPSCSep 12, 2024Nationwide• Glen Dimplex Americas Ltd., of Vancouver, Washington

SynchroMed II Infusion Pump (Medtronic) – Memory Corruption (2024)

Potential for error and inability to interrogate pump due to data corruption in the pump memory.

High

FDASep 11, 2024Nationwide• Medtronic Neuromodulation

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.

High

FDASep 11, 2024Nationwide• Olympus Corporation of the Americas

Proparacaine Ophthalmic Solution (Mckesson) – Temperature Abuse (2024)

Temperature abuse: Products exposed to improper temperature above drug label specifications.

Class IIModerate

FDASep 11, 2024IN, MD, VA• Mckesson Medical-Surgical Inc. Corporate Office

First Aid Antiseptic Ointment (Zhejiang Jingwei) – Incorrect Ingredients (2024)

Undeclared Allergen

Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The inactive ingredients in the actual product are polyethylene glycol 400 , polyethylene glycol 4000.

Class IIModerate

FDASep 11, 2024Nationwide• Zhejiang Jingwei Pharmaceutical Co., Ltd.

Hylenex Injection (Mckesson) – Temperature Excursion (2024)

cGMP Deviations: Temperature excursion

Class IIModerate

FDASep 11, 2024Nationwide• Mckesson Medical-Surgical Inc. Corporate Office

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.

Low

FDASep 9, 2024Nationwide• Atrium Medical Corporation

SONIALVISION G4 (Shimadzu) – Image Display Problem (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.

Moderate

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

FLUOROspeed (Shimadzu) – Image Display Issue (2024)

Moderate

FDASep 6, 2024Nationwide• 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.

Moderate

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

myLUX Patient App (Boston Scientific) – Data Transmission Issue (2024)

Patients using the Model 2939 myLUX Patient Application on their Apple mobile device (e.g., iPhone) may not be transmitting data from their Insertable Cardiac Monitor to the LATITUDE Clarity website.

Moderate

FDASep 6, 2024Nationwide• Boston Scientific Corporation

NxTAG Respiratory Panel (Luminex) – Target Detection Issue (2024)

Respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence) of non-specific hMPV target (human Metapneumovirus) results, risk identified predominantly in clinical samples that present positivity for another target, leading to an erroneous co-infection result, can potentially result in hMPV false positives.

Low

FDASep 5, 2024Nationwide• Luminex Molecular Diagnostics Inc

AVVIGO+ Guidance System (Boston Scientific) – Overlay Error (2024)

Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality Guidance System while in either Live or Record mode. The Boston Scientific investigation determined that, due to a software anomaly, a 9-grid mark overlay is incorrectly displayed during Live mode when AVVIGO+ is connected to an OptiCross 18 Peripheral Imaging Catheter. Note that the correct overlay display for this catheter is the 15-grid mark overlay, which allows for a reference depth setting of 14.9mm for peripheral catheters. This software anomaly is limited to Live or Record mode. In Review mode, the correct 15-grid mark overlay is displayed, and the vessel image is correctly scaled to the appropriate size.

Moderate

FDASep 5, 2024Nationwide• Boston Scientific Corporation

Triathlon Universal Baseplate (Howmedica) – Locking Tabs Issue (2024)

Anterior locking tabs on the Triathlon Universal Baseplate are out of specification which may prevent engagement of either of the two locking tabs with the locking wire of the tibial insert.

High

FDASep 4, 2024Nationwide• Howmedica Osteonics Corp.