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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 5021–5040 of 21320 recalls

Olympus PowerSeal 5MM Sealer (Olympus) – Rotation Knob Issue (2022)

An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and retention ring and cause delay of treatment

Moderate

FDAAug 12, 2022Nationwide• Olympus Corporation of the Americas

Olympus PowerSeal 5MM Sealer (Olympus) – Rotation Knob Issue (2022)

Moderate

FDAAug 12, 2022Nationwide• Olympus Corporation of the Americas

IMMULITE Thyroid Test (Siemens) – Negative Bias (2022)

An average negative bias of -23% with IMMULITE 2000/IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) when compared to other in-date kit lots, there is a potential for erroneously depressed patient results. This may lead to a delayed follow up of patients with clinical autoimmune thyroid

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Moderate

FDAAug 11, 2022Nationwide• Siemens Healthcare Diagnostics, Inc.

IC Bus CESB (IC Bus) – Engine Control Module (2022)

Navistar, Inc. (Navistar) is recalling certain 2023 IC CE School Buses. The engine control module (ECM) may experience an internal electrical short-circuit, causing the engine to stall.

High

NHTSAAug 10, 2022Nationwide• IC BUS

Artis Icono X-Ray System (Siemens) – Hardware Issue (2022)

Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. In rare cases, if the error detection mechanism fails, it will not be possible to release X-ray any longer until system shutdown.

Moderate

FDAAug 10, 2022Nationwide• Siemens Medical Solutions USA, Inc

Artis Pheno X-Ray System (Siemens) – Hardware Issue (2022)

Moderate

FDAAug 10, 2022Nationwide• Siemens Medical Solutions USA, Inc

Artis Q X-Ray System (Siemens) – Hardware Issue (2022)

Moderate

FDAAug 10, 2022Nationwide• Siemens Medical Solutions USA, Inc

VenaCure EVLT Kit (Angiodynamics) – Fiber Dimension Problem (2022)

OPS Fiber packaged within specific VenaCure EVLT Procedure Kits does not meet the required dimensional specification, may result in damage to the sheath, including separation or the inability to move the fiber within the sheath. A damaged sheath will necessitate removal from the patient, which may result in procedural delay and/or surgical intervention

High

FDAAug 10, 2022Nationwide• Angiodynamics, Inc.

Subdermal Needle Electrode (Technomed) – MRI Safety (2022)

Fire/Burn Risk

Burns of varying degrees can occur to patients with electrodes left in while in the MRI scanner as a result of inadequate safety information in the IFU.

Moderate

FDAAug 9, 2022Nationwide• Technomed Europe Amerikalaan 71 Maastricht-Airport Netherlands

BioZorb LP Marker (Hologic) – Expiration Label (2022)

Hologic BioZorb LP Marker, (Product number F0221), lot number 22A0RL, contained removable labels with an expiration date that indicated the product had already expired. The expiration date on the removable label is actually manufacturing date, and it's different from the one on the shelf box label, which is the correct expiration date.

Moderate

FDAAug 9, 2022Nationwide• Hologic, Inc

Boston Scientific Guider Softip (Boston Scientific) – Tip Curve Mismatch (2022)

The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter.

Low

FDAAug 9, 2022IN• Boston Scientific Corporation

PDS II Suture (Ethicon) – Material Error (2022)

Product may contain the incorrect material which could impact treatment.

Low

FDAAug 8, 2022IN• Ethicon, Inc. Us

Stryker USB Converter (Mako) – Potential Failure (2022)

Certain units have the potential to exhibit infant failures whereby units either arrive non-functional, have the potential to become non-functional, or flash an error light while in use.

Low

FDAAug 8, 2022AZ, IL• Mako Surgical Corporation

Stryker EVOLVE Proline Stem (Wright) – Label Mismatch (2022)

The outer label does not match the device inside the package. The affected lot of EVOLVE Proline Stem 7.5mm +2 contains a size 9.5mm +4 stem, while the affected lot of EVOLVE Proline Stem 9.5mm +4 contains a size 7.5mm +2 stem.

Low

FDAAug 3, 2022Nationwide• Wright Medical Technology, Inc.

CorVocet Biopsy System (Merit) – Needle Ejection (2022)

Biopsy Systems have components that are misaligned due to an issue with the manufacturing assembly equipment, which may lead to the needle ejecting when triggered outside the body, which may result in user or patient needle stick injury.

High

FDAAug 3, 2022AL, AK, AZ +40 more• Merit Medical Systems, Inc.

Vitamin Herb Blend (Eclectic Institute) – Ingredient Mislabeling (2022)

Product's ingredients names such as Oregon Grape, Cayenne Root, and Ginger Fruit and their quantities were not listed correctly in the Supplement Facts panel.

Class IIILow

FDAAug 3, 2022Nationwide• Eclectic Institute Inc

Zynrelef (Heron Therapeutics) – Defective Syringe (2022)

Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit

Class IIILow

FDAAug 2, 2022Nationwide• HERON THERAPEUTICS, INC.

Smallbore Bifuse Extension Set (ICU Medical) – Manufacturing Gap (2022)

Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.

High

FDAAug 1, 2022AL, AK, AZ +49 more• ICU Medical, Inc.

Bifuse Pressure Infusion Set (ICU Medical) – Manufacturing Gap (2022)

Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.

High

FDAAug 1, 2022AL, AK, AZ +49 more• ICU Medical, Inc.

MicroClave Clear Connector (ICU Medical) – Manufacturing Gap (2022)

Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.

High

FDAAug 1, 2022AL, AK, AZ +49 more• ICU Medical, Inc.