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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

276

Class I (Serious)

242

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 481–500 of 4099 recalls

PowerSeal 37cm Curved Jaw Sealer (Olympus) – Incomplete Seal Cycle (2024)

Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on the generator screen, and no energy would be delivered to the device resulting in delay in surgery.

FDAMar 7, 2024Nationwide• Olympus Corporation of the Americas

Clinical Chemistry Calibration Serum (Randox) – Phosphate Bias (2024)

Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL10388, is running with a negative bias on RX Series instruments compared to other methods.

FDAMar 5, 2024Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

Natural Artesian Water (Fiji) – Bacterial Contamination (2024)

Firm testing revealed Manganese in addition to three bacterial genera.

1...23 242526 27...205

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Class III

Low

FDAMar 4, 2024Nationwide• Natural Waters of Viti Limited

Liquid Protein Calibrators (Randox) – Calibration Realignment (2024)

The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC.

FDAMar 1, 2024CA, FL, IL +4 more• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

Triangle Tip Electrosurgical Knives (Olympus) – Breakage Warning (2024)

Due to increase in complaints for the KD-640L and KD-645L Triangle Tip Electrosurgical Knives breaking off during use -issuing reminder to users to utilize the electrosurgical knife in accordance with the Instructions for Use, which details critical specifications regarding electrosurgical unit compatibility and output due to reports of serious injury

FDAMar 1, 2024Nationwide• Olympus Corporation of the Americas

Ski-Doo Snowmobiles (BRP) – Injury Risk (2024)

This recall involves all model year 2024 Ski-Doo MXZ and Renegade snowmobiles models equipped with Pilot X skis. The vehicles were sold in a variety of colors. Ski-Doo and the model name are printed on the side panels of the vehicles. Pilot X is engraved at the back of the ski, on the upper side. The vehicle identification number (VIN) is on the decal located on the right-hand side of tunnel underneath the seat. Dealers can check for VINs included in this recall.

CPSCFeb 29, 2024Nationwide• Bombardier Recreational Products Inc., of Canada

Hydrogen Peroxide Mouthwash (Nutraceutical) - poisoning risk (2024)

This recall involves Heritage Store Hydrogen Peroxide Mouthwash in Wintermint and Eucalyptus Mint flavors. The bottles are a dark opaque brown with a white lid. The pink and white label on the front of the bottles displays the Heritage Store logo, product name and flavor. All lots are included in the recall.

CPSCFeb 29, 2024Nationwide• Nutraceutical Corporation, of Salt Lake City, Utah

DX-D 100 X-Ray System (Agfa) – Cable Interference Risk (2024)

Laceration Risk

Steel cable installed inside the mobile column which supports the weight of the telescopic arm with the tube head has potential risk -an interference could cause the safety system which blocks the arm if the cable is cut off does not work properly, may result in patient injury

FDAFeb 23, 2024Nationwide• Agfa N.V. Septestraat 27 Mortsel Belgium

RayStation Software (RaySearch) – Material Override Error (2024)

A use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si, was incorrectly selected for a silicone gel polymer implant.

FDAFeb 23, 2024Nationwide• RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden

HotDog Return Electrode (Augustine) – Electrode Contact Issue (2024)

Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact .

FDAFeb 15, 2024AL, NV, TX• Augustine Temperature Management, LLC

Cystatin C Calibrator (Randox) – Bias Concern (2024)

Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods

FDAFeb 14, 2024Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

Bugatti Chiron (Bugatti) – Safety Chime Malfunction (2024)

Bugatti is recalling certain 2016-2023 Bugatti Chiron vehicles. The audible chime may not activate when the vehicle starts, and the driver has not buckled their seat belt. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard (FMVSS) number 208, "Occupant Crash Protection."

NHTSAFeb 9, 2024Nationwide• BUGATTI

Cerebase DA Guide Sheath (Medos) – Fracture Risk (2024)

Medos has received an increase in complaints for CEREBASE DA Guide Sheath with reports of fractures at the distal end, which may result in surgical procedural delay, vascular injury and in extreme rare occasions it may result in embolism.

FDAFeb 2, 2024Nationwide• Medos International Sarl Chemin Blanc 36 Le Locle Switzerland

Lansoprazole Capsules (NATCO Pharma) – Inadequate Sealing (2024)

CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to capsules. Also coding details were missing on one bottle.

Class IIModerate

FDAFeb 1, 2024Nationwide• NATCO Pharma Limited

Microalbumin Calibrator (Randox) – Result Misclassification (2024)

Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other methods and may misclassify patient results. Users may experience a shift in Quality Control and patient sample recovery of up to +12%.

FDAJan 31, 2024Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

Trinias Angiography System (Shimadzu) – Flat Panel Malfunction (2024)

Due to capacitor manufacturing issue, their is a potential that Flat Panel Device may have abnormal display or no function.

FDAJan 29, 2024Nationwide• SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku

Soltive Laser (Olympus) – Non-Compliant Power Cord (2024)

A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations.

FDAJan 29, 2024IN• Olympus Corporation of the Americas

Soltive Pro Laser (Olympus) – Non-Compliant Power Cord (2024)

A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations.

FDAJan 29, 2024IN• Olympus Corporation of the Americas

TrueDent Yellow (Stratasys) – Expiration Date Error (2024)

Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.

FDAJan 19, 2024Nationwide• STRATASYS LTD

TrueDent Clear (Stratasys) – Expiration Date Error (2024)

FDAJan 19, 2024Nationwide• STRATASYS LTD