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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 3641–3660 of 21320 recalls

EVIS EXERA III Duodenovideoscope (Olympus) – infection risk (2023)

Recent reports of patient infection.

Moderate

FDAJul 27, 2023Nationwide• Olympus Corporation of the Americas

Guider Softip Guide Catheter 8F (Boston Scientific) – tip curve issue (2023)

Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

Moderate

FDAJul 27, 2023Nationwide• Boston Scientific Corporation

Guider Softip Guide Catheter 6F (Boston Scientific) – tip curve issue (2023)

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Moderate

FDAJul 27, 2023Nationwide• Boston Scientific Corporation

Guider Softip Guide Catheter 5F (Boston Scientific) – tip curve issue (2023)

Moderate

FDAJul 27, 2023Nationwide• Boston Scientific Corporation

Airway Mobilescope (Olympus) – endoscope lodging risk (2023)

Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.

Moderate

FDAJul 27, 2023Nationwide• Olympus Corporation of the Americas

Tobramycin Ophthalmic Solution (Alembic) – Impurity Specifications (2023)

Failed Impurities/Degradation Specifications

Class IIILow

FDAJul 27, 2023Nationwide• ALEMBIC PHARMACEUTICALS, INC.

Guider Softip Guide Catheter 7F (Boston Scientific) – tip curve issue (2023)

Moderate

FDAJul 27, 2023Nationwide• Boston Scientific Corporation

Tracheal Intubation Fiberscope (Olympus) – endoscope lodging risk (2023)

Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.

Moderate

FDAJul 27, 2023Nationwide• Olympus Corporation of the Americas

Bronchovideoscope (Olympus) – endoscope lodging risk (2023)

Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.

Moderate

FDAJul 27, 2023Nationwide• Olympus Corporation of the Americas

Hamilton-C1 Ventilator (Hamilton) – control board leak (2023)

Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose function and lead to interruption of ventilation.

Moderate

FDAJul 26, 2023Nationwide• Hamilton Medical, Inc.

ADVIA Chemistry Protein Test (Siemens) – reagent carryover (2023)

There is a potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Creatinine_2 (ECRE_2). Falsely depressed ECRE_2 results may be observed when the assay is processed after the UCFP test on ADVIA Chemistry systems.

Moderate

FDAJul 25, 2023Nationwide• Siemens Healthcare Diagnostics, Inc.

O-arm O2 Imaging System (Medtronic) – ground cable problem (2023)

Ground cable installed incorrectly.

Moderate

FDAJul 25, 2023Nationwide• Medtronic Navigation, Inc.-Littleton

Breaded Mozzarella Sticks (Member's Mark) – undeclared allergens (2023)

Undeclared Egg

Product contains undeclared egg and soy.

Class IHigh

FDAJul 24, 2023KY, OH, PA +2 more• Rich Products Corp

Phoroptor VRX System (Reichert) – Head Detachment Risk (2023)

Phoroptor VRx Head may detach from the bracket that connects the Phoroptor VRx Head to an ophthalmic stand. If the Phoroptor VRx Head detaches from the bracket, it can fall onto a patient or device operator

Moderate

FDAJul 20, 2023Nationwide• Reichert, Inc.

Visera Hysterovideoscope (Olympus) – Labeling Update (2023)

IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes.

Low

FDAJul 20, 2023Nationwide• Olympus Corporation of the Americas

Stay Informed

Olympus Corporation of the Americas Recalls

Recall Summary

EVIS EXERA III Duodenovideoscope (Olympus) – infection risk (2023)

Guider Softip Guide Catheter 8F (Boston Scientific) – tip curve issue (2023)

Guider Softip Guide Catheter 6F (Boston Scientific) – tip curve issue (2023)

Guider Softip Guide Catheter 5F (Boston Scientific) – tip curve issue (2023)

Airway Mobilescope (Olympus) – endoscope lodging risk (2023)

Tobramycin Ophthalmic Solution (Alembic) – Impurity Specifications (2023)

Guider Softip Guide Catheter 7F (Boston Scientific) – tip curve issue (2023)

Tracheal Intubation Fiberscope (Olympus) – endoscope lodging risk (2023)

Bronchovideoscope (Olympus) – endoscope lodging risk (2023)

Hamilton-C1 Ventilator (Hamilton) – control board leak (2023)

Hamilton-T1 Ventilator (Hamilton) – control board leak (2023)

Hamilton-T1 ESM Shielding Set (Hamilton) – control board leak (2023)

Hamilton Control Board (Hamilton) – control board leak (2023)

Hamilton-T1 Ventilator (Hamilton) – control board leak (2023)

Hamilton-MR1 Ventilator (Hamilton) – control board leak (2023)

ADVIA Chemistry Protein Test (Siemens) – reagent carryover (2023)

O-arm O2 Imaging System (Medtronic) – ground cable problem (2023)

Breaded Mozzarella Sticks (Member's Mark) – undeclared allergens (2023)

Phoroptor VRX System (Reichert) – Head Detachment Risk (2023)

Visera Hysterovideoscope (Olympus) – Labeling Update (2023)