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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)

127

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 3381–3400 of 25002 recalls

EVIS EXERA b Bronchovideoscope (Olympus) – combustion risk (2023)

There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.

High

FDAOct 12, 2023Nationwide• Olympus Corporation of the Americas

Radiology Solutions (Change Healthcare) – record update issue (2023)

Change Healthcare has identified a software issue where Change Healthcare Radiology Solutions 14.0, 14.1, and 14.2 may not update records in external applications.

Low

FDAOct 12, 2023Nationwide• CHANGE HEALTHCARE CANADA COMPANY

EVIS EXERA III Bronchovideoscope (Olympus) – combustion risk (2023)

1...168 169170171 172...1251

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High

FDAOct 12, 2023Nationwide• Olympus Corporation of the Americas

Bronchovideoscope (Olympus) – combustion risk (2023)

High

FDAOct 12, 2023Nationwide• Olympus Corporation of the Americas

Allison Transmission B3400 (Allison) – Driveshaft Issue (2023)

Allison Transmission, Inc. (ATI) is recalling certain models B3400xFE_R and B400R, with part numbers B3400xFE_R and B400R. The transmission yoke may separate, resulting in driveshaft separation and a sudden loss of drive power.

High

NHTSAOct 11, 2023Nationwide• ALLISON TRANSMISSION, INC

RANDOX Total Bilirubin (Randox Laboratories) – Elevated Patient Results (2023)

Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Method.

Moderate

FDAOct 11, 2023Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

VariSoft Infusion Set (Unomedical A/S) – Connector Damage (2023)

The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported was damage to the connector piece during manufacturing. This damage results in the connector becoming detached more easily from the insulin set than expected, requiring less force to disconnect than intended. Disconnection, when not detected, for example during sleep, leads to missed basal dosing. which in turn can result in elevated blood glucose and ketone level (nocturnal hyperglycemia). Diabetic ketoacidosis.

High

FDAOct 11, 2023Nationwide• Unomedical A/S Aaholmvej

CARDIOHELP Emergency Drive (Maquet) – Patient Exposure Risk (2023)

Product removal due to possible blocking or impairment of the CARDIOHELP Emergency Drive. This issue can lead to the patient being exposed to inappropriate low blood flow. Potential associated harms are ischemia and hypoxia.

High

FDAOct 10, 2023Nationwide• Maquet Medical Systems USA

Automated Impella Controller (Abiomed) – Software Connection Issue (2023)

Pump not detected as connected to controller due to software issue.

Moderate

FDAOct 10, 2023AZ, CA, FL +2 more• Abiomed, Inc.

AMETEK ICM-200 (AMETEK) – Software Malfunction (2023)

AMETEK ICVS (AMETEK ICVS) has submitted a Part 573 Recall Report based upon recall determinations made by Shyft Group (23V-062). The Ignition Control Module (ICM) software error may cause loss of drive power or loss of key safety functions, such as loss of head lights or windshield wipers.

High

NHTSAOct 10, 2023Nationwide• AMETEK

Platinum Driveline Clutch Cover (Platinum) – Potential Failure (2023)

Platinum Driveline, Inc. (Platinum Driveline) is recalling certain Platinum and Luk Mustang clutch covers, part number 361986 with 11" outer diameter plate. The clutch cover may have been manufactured with material that may break.

Moderate

NHTSAOct 10, 2023Nationwide• PLATINUM DRIVELINE USA

Spectral CT on Rails (Philips) – IVC Needle Position Issue (2023)

This recall is part of a 2-issue recall for the same system. When using the IVC needle position button, on the IVC control box during a series of scans, the plan box may not move to the desired needle position. This issue could result in the gantry moving to a location the operator does not expect. If this occurs, it presents a risk that the scan could occur at an incorrect location, or that the unintended motion of the gantry could cause a collision with the user or needle. The other part of the recall involves a software crash when the CCT foot pedal is activated (as described in RES ID93363).

High

FDAOct 9, 2023Nationwide• Philips North America

Spectral CT on Rails (Philips) – Software Crash Risk (2023)

When preparing for CCT Fluoroscopy mode and activating the CCT foot pedal simultaneously, the operator may experience a software crash. This would result in the system needing to be restarted.

Moderate

FDAOct 9, 2023Nationwide• Philips North America

Big Bore RT CT Scanner (Philips) – Contouring Shift Risk (2023)

For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using image fusion (on TPS) and incorrect coordinates may be sent to TPS system when using absolute patient marking. This may lead to incorrect radiation therapy planning and possible growth or spread of cancer due to incorrect early treatment regimen. For radiology users: If the user performed off-set reconstruction on CT devices, after multiple acquisitions, the Relate Position could be inaccurate. This could lead to incorrect diagnosis and treatment.

High

FDAOct 9, 2023Nationwide• Philips North America Llc

Brilliance CT Big Bore (Philips) – Contouring Shift Risk (2023)

High

FDAOct 9, 2023Nationwide• Philips North America Llc

Brilliance CT Big Bore Oncology (Philips) – Contouring Shift Risk (2023)

High

FDAOct 9, 2023Nationwide• Philips North America Llc

D-Clip Applier (Peter Lazic) – Surgery Failure Risk (2023)

Customer complaint received that reported the applier failed during surgery. The applier did not release the clip. The applier remained attached to the clip.

Moderate

FDAOct 6, 2023Nationwide• Peter Lazic Gmbh Immelmannweg 2 Tuttlingen Germany

Contra Gray Turbo Plus Cups (Young Dental) – Incorrect Cup Type (2023)

one lot of Contra Gray (soft) Turbo Plus Cups Dental Prophylaxis Angles may contain Contra Petite Web LF Soft Purple Cup DPAs.

Low

FDAOct 6, 2023IN, MO, TN• Young Dental Manufacturing I, LLC

ORION System (LEONI) – Unintended Movement Risk (2023)

Users of the patient positioning system ORION System can be faced with a sudden short-term acceleration or with an unintended short-distance movement when the movements are again allowed after an unforeseen interruption signal of motion may result in a collision of the patient with another stationary component of the treatment room.

High

FDAOct 6, 2023Nationwide• LEONI CIA CABLE SYSTEMS 5 avenue Victor Hugo Chartres France

D-Clip Applier (Peter Lazic) – Surgery Failure Risk (2023)

Customer complaint received that reported the applier failed during surgery. The applier did not release the clip. The applier remained attached to the clip.

Moderate

FDAOct 6, 2023Nationwide• Peter Lazic Gmbh Immelmannweg 2 Tuttlingen Germany