Manufacturer
332 recalls in our database name Olympus Corporation of the Americas as the manufacturing or recalling firm.
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
Olympus is recalling the OES Bronchofiberscope Model BF-1T60 for instruction updates needed to clarify safe use when combined with laser, argon plasma, and high-frequency therapy equipment.
Olympus Corporation recalled the EVIS EXERA III bronchoscope (4,297 US units; 4,290 international units) for instruction clarification regarding safe use with laser, argon plasma coagulation, and high-frequency therapy equipment.
Olympus is updating instructions for the EVIS EXERA II bronchovideoscope to clarify safe use with laser, argon plasma coagulation, and high-frequency therapy equipment. This Class I recall affects 215 units distributed nationwide in the US.
Olympus is updating bronchovideoscope instructions for safe use with laser, coagulation, and high-frequency therapy equipment. The Class I recall affects 665 US units.
Olympus is clarifying instructions for safe use of its EVIS EXERA III bronchoscopes when used with laser, argon plasma coagulation, or high-frequency therapy equipment. This FDA Class I recall affects 916 units in the US.
Olympus is providing clarified instructions for the EVIS EXERA III bronchovideoscope to ensure safe use with laser, argon plasma coagulation, and high-frequency therapy equipment. This FDA Class I recall affects approximately 3,046 units in the US.
Olympus is recalling EVIS EXERA II bronchoscopes to provide clarification on safe and effective use when these devices are used with laser, argon plasma coagulation, and high-frequency therapy equipment.
Olympus Corporation of the Americas is recalling ViziShot 2FLEX Single Use Aspiration Needles (Model NA-U403SX-4019) due to potential deformation of needle tips. The defect may cause unintended tissue trauma during biopsy procedures.
The Olympus ESG-410 Electrosurgical Generator may display an E0662 system error and reboot unexpectedly. The FDA Class II recall affects 155 units distributed nationwide, with specific serial numbers listed in the recall notice.
Olympus ESG-410 Electrosurgical Generators may display a system error and reboot or enter continuous reboot loops during use. This could interrupt surgical procedures.
Olympus reusable silicone seals for endoscopes are recalled because Japanese-language package instructions differ from the official sterilization guidance. Users following the incorrect instructions may not properly sterilize the device.
Olympus recalls Model 190A Ellik Evacuator glass bodies due to discrepancies between sterilization instructions in Japanese and English product materials. Healthcare facilities should verify correct sterilization procedures with the manufacturer.
Olympus recalls Ellik Evacuator Adapter 190-NRS due to discrepancies between Japanese and English sterilization instructions that could lead to improper device sterilization.
Olympus recalls Ellik Evacuators due to discrepancies in sterilization instructions between Japanese product inserts and manufacturer documentation. Inconsistent sterilization procedures could affect device safety.
Olympus is recalling tubing for the Ellik Evacuator due to discrepancies between sterilization instructions in Japanese language package inserts and the manufacturer's Instructions for Use.
Olympus is recalling Ellik Evacuator Model 191-NRS due to discrepancies between sterilization instructions in Japanese-language product inserts and the manufacturer's English Instructions For Use. Sterilization instruction discrepancies may affect proper device preparation before use.
Olympus Corporation recalls 41 Green Silicone Seal accessories (CS-G7) for endoscopes distributed to Japan. Sterilization instructions differ between Japanese product inserts and manufacturer documentation, potentially affecting proper device sterilization.
Olympus Corporation is recalling Ellik Evacuator surgical devices due to discrepancies between sterilization instructions in Japanese product package inserts and the English product Instructions For Use.
Olympus is recalling 1,549 SOLTIVE surgical laser systems due to potential thermal incidents—including smoke, sparks, burning, or unsteady flames—caused by fiber fracturing during clinical use.
Olympus is recalling Soltive SuperPulsed Laser Fibers due to potential thermal incidents including smoke, sparks, burning, and flames during surgical use, caused by fiber fracturing. No injuries have been reported.
Olympus SOLTIVE Pro SuperPulsed Laser System recalled due to potential thermal incidents (smoke, sparks, burning, flames) caused by fiber fracturing during clinical use. Affects 201 units worldwide.
Olympus Soltive laser fibers used in surgical procedures may fracture, creating a risk of thermal incidents including smoke, sparks, and burning during use.
Olympus Corporation recalls approximately 12,195 EVIS EXERA III Duodenovideoscopes (Model TJF-Q190V) worldwide. Post-market surveillance data suggests higher microbial contamination levels when manual cleaning is delayed beyond one hour and a presoak is performed.
Olympus is recalling SOLTIVE Pro SuperPulsed Laser Systems because preset treatment parameters may not be consistently applied according to product instructions. Affected healthcare facilities should contact Olympus for corrective action.
Olympus Single Use Guide Sheath Kits (models K-201 through K-204) are recalled because the radiopaque tip of the guide sheath may detach and fall into the patient during respiratory procedures.