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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 2441–2460 of 21320 recalls

EasySuite 4K Operating Room System (Olympus) – Testing Records (2024)

A subset of the ES4K systems do not have complete records for earth leakage testing. The earth leakage test is a series of measurements intended to confirm that the amount of electrical current flowing to the earth is within standard limits

Low

FDAApr 24, 2024Nationwide• Olympus Corporation of the Americas

Haloperidol Injection (Somerset) – Foreign Substance (2024)

Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).

Class IIModerate

FDAApr 24, 2024Nationwide• SOMERSET THERAPEUTICS LLC

Sodium Sulfacetamide Cleanser (Acella) – Subpotent Drug (2024)

Subpotent drug

Class III

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Low

FDAApr 24, 2024Nationwide• Acella Pharmaceuticals, LLC

Cefdinir Suspension (Lupin) – Foreign Material (2024)

Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.

Class IIModerate

FDAApr 24, 2024Nationwide• Lupin Pharmaceuticals Inc.

Cefdinir Suspension (Lupin) – Foreign Material (2024)

Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.

Class IIModerate

FDAApr 24, 2024Nationwide• Lupin Pharmaceuticals Inc.

Monoject Syringe (McKesson) – Distribution Error (2024)

Quarantined product was inadvertently distributed

Low

FDAApr 23, 2024Nationwide• Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233

SURGIFOAM Gelatin Powder Kit (Ethicon) – Applicator Seal (2024)

Some applicator tips from these lots had open seals.

Low

FDAApr 23, 2024Nationwide• Ethicon, Inc. Us

IMMULITE 2000 Anti-TG Ab (Siemens) – Result Elevation (2024)

The potential for falsely elevated patient sample results when using impacted lots (782, 783, 785, 786, 787, 788, 789, 790, 791, 792 and 793), of IMMULITE 2000 Anti-TG Ab.

Moderate

FDAApr 23, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

EYLEA Injection (Regeneron) – Syringe Breakage (2024)

Lack of Assurance of Sterility: Complaints of syringe breakage

Class IIModerate

FDAApr 23, 2024Nationwide• Regeneron Pharmaceuticals Inc

Prucka 3 Amplifier (GE Medical) – capacitor failure (2024)

Capacitors in certain Prucka 3 Amplifiers used with CardioLab / ComboLab systems could fail resulting in transient oscillations on the display and inability to view surface and intracardiac ECG waveforms.

Moderate

FDAApr 22, 2024Nationwide• GE Medical Systems Information Technologies Inc

Ingenia 3.0T MRI System (Philips) – ventilation warning issue (2024)

Fire/Burn Risk

Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilation setting which may lead to increase in body temperature or burning sensation

High

FDAApr 22, 2024Nationwide• Philips North America Llc

Xelpros (Sun Pharmaceutical) – Failed Particulate Test (2024)

Failed Release Testing: Out of specification for particulate matter test.

Class IIILow

FDAApr 22, 2024PA, TX• SUN PHARMACEUTICAL INDUSTRIES INC

Ingenia 1.5T MRI System (Philips) – ventilation warning issue (2024)

Fire/Burn Risk

Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilation setting which may lead to increase in body temperature or burning sensation

High

FDAApr 22, 2024Nationwide• Philips North America Llc

Patient Information Center iX (Philips) – data transfer problem (2024)

Event Catalog information does not save when copied and transferred from one unit to another.

Low

FDAApr 19, 2024Nationwide• Philips North America Llc

Amphotericin B Liposome (Sun Pharmaceutical) – Assay Issue (2024)

Out of specification for assay

Class IIModerate

FDAApr 19, 2024Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Vercise Genus DBS Implantable Pulse Generator (Boston Scientific) – system check issue (2024)

Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset. The device reset could lead transient loss of stimulation; patients may experience undesired sensations, transient worsening of movement disorder symptoms, which may lead patient to request surgical intervention for replacement or revision.

High

FDAApr 18, 2024Nationwide• Boston Scientific Neuromodulation Corporation

OES 4000 Hysteroscope (Olympus) – leakage test omission (2024)

The required leakage test was not performed following of a re-work for a non-conformity. This could potentially result in liquid ingress into the eyepiece and cause a foggy image.

Low

FDAApr 18, 2024Nationwide• Olympus Corporation of the Americas