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Recall company profile

Olympus Corporation of the Americas Recalls

Overview of recall records associated with Olympus Corporation of the Americas, including dates, categories and classifications where available.

233recall records

Sep 2, 2026latest record date

Mar 7, 2018earliest record date

Recall history in this database

Classification mix: Class II: 217, Class I: 14, Class III: 2.

Medical DeviceFeb 25, 2026

Olympus High Flow Insufflation Unit recall — FDA Z-1354-2026

Issue with software algorithm which may lead to overpressure events.

Class IFDA: OngoingOlympus Corporation of the Americas

Medical DeviceFeb 25, 2026

Olympus High Flow Insufflation Unit recall — FDA Z-1353-2026

Issue with software algorithm which may lead to overpressure events.

Class IFDA: OngoingOlympus Corporation of the Americas

Medical DeviceFeb 25, 2026

Olympus High Flow Insufflation Unit recall — FDA Z-1352-2026

Issue with software algorithm which may lead to overpressure events.

Class IFDA: OngoingOlympus Corporation of the Americas

Medical DeviceFeb 11, 2026

Olympus Corporation of the Americas Single Use 3-Lumen Sphincterotome V recall — FDA Z-1290-2026

Devices which did not undergo thermoforming could deform and lose performance.

Class IIFDA: OngoingOlympus Corporation of the Americas

Medical DeviceFeb 11, 2026

Olympus Corporation of the Americas Disposable Triple Lumen Sphincterotome recall — FDA Z-1287-2026

Devices which did not undergo thermoforming could deform and lose performance.

Class IIFDA: OngoingOlympus Corporation of the Americas

Medical DeviceFeb 11, 2026

Olympus Corporation of the Americas Single Use 3-Lumen Sphincterotome V recall — FDA Z-1271-2026

Devices which did not undergo thermoforming could deform and lose performance.

Class IIFDA: OngoingOlympus Corporation of the Americas

Medical DeviceFeb 11, 2026

Olympus Corporation of the Americas Single Use 3-Lumen Sphincterotome V recall — FDA Z-1273-2026

Devices which did not undergo thermoforming could deform and lose performance.

Class IIFDA: OngoingOlympus Corporation of the Americas

Medical DeviceFeb 11, 2026

Olympus Corporation of the Americas Disposable Triple Lumen Sphincterotome recall — FDA Z-1289-2026

Devices which did not undergo thermoforming could deform and lose performance.

Class IIFDA: OngoingOlympus Corporation of the Americas

Medical DeviceFeb 11, 2026

Olympus Corporation of the Americas Single Use 3-Lumen Sphincterotome V recall — FDA Z-1296-2026

Devices which did not undergo thermoforming could deform and lose performance.

Class IIFDA: OngoingOlympus Corporation of the Americas

Medical DeviceFeb 11, 2026

Olympus Corporation of the Americas Disposable Triple Lumen Sphincterotome recall — FDA Z-1270-2026

Devices which did not undergo thermoforming could deform and lose performance.

Class IIFDA: OngoingOlympus Corporation of the Americas

Medical DeviceFeb 11, 2026

Olympus Corporation of the Americas Disposable Triple Lumen Sphincterotome recall — FDA Z-1288-2026

Devices which did not undergo thermoforming could deform and lose performance.

Class IIFDA: OngoingOlympus Corporation of the Americas

Medical DeviceFeb 11, 2026

Olympus Corporation of the Americas Single Use 3-Lumen Sphincterotome V (Distal Wire guided) recall — FDA Z-1297-2026

Devices which did not undergo thermoforming could deform and lose performance.

Class IIFDA: OngoingOlympus Corporation of the Americas

Medical DeviceFeb 11, 2026

Olympus Corporation of the Americas Disposable Triple Lumen Sphincterotome recall — FDA Z-1286-2026

Devices which did not undergo thermoforming could deform and lose performance.

Class IIFDA: OngoingOlympus Corporation of the Americas

Medical DeviceFeb 11, 2026

Olympus Corporation of the Americas Single Use 3-Lumen Sphincterotome V (Distal Wire guided) recall — FDA Z-1278-2026

Devices which did not undergo thermoforming could deform and lose performance.

Class IIFDA: OngoingOlympus Corporation of the Americas

Medical DeviceFeb 11, 2026

Olympus Corporation of the Americas Single Use 3-Lumen Sphincterotome V recall — FDA Z-1275-2026

Devices which did not undergo thermoforming could deform and lose performance.

Class IIFDA: OngoingOlympus Corporation of the Americas

Medical DeviceFeb 11, 2026

Olympus Corporation of the Americas Single Use 3-Lumen Sphincterotome V (Distal Wire guided) recall — FDA Z-1277-2026

Devices which did not undergo thermoforming could deform and lose performance.

Class IIFDA: OngoingOlympus Corporation of the Americas

Medical DeviceFeb 11, 2026

Olympus Corporation of the Americas Disposable Triple Lumen Sphincterotome recall — FDA Z-1285-2026

Devices which did not undergo thermoforming could deform and lose performance.

Class IIFDA: OngoingOlympus Corporation of the Americas

Medical DeviceFeb 11, 2026

CleverCut Single Use 3-Lumen Sphincterotome V recall — FDA Z-1268-2026

Devices which did not undergo thermoforming could deform and lose performance.

Class IIFDA: OngoingOlympus Corporation of the Americas

Medical DeviceFeb 11, 2026

Olympus Corporation of the Americas Single Use 3-Lumen Sphincterotome V (Distal Wire guided) recall — FDA Z-1284-2026

Devices which did not undergo thermoforming could deform and lose performance.

Class IIFDA: OngoingOlympus Corporation of the Americas

Medical DeviceFeb 11, 2026

Olympus Corporation of the Americas Single Use 3-Lumen Sphincterotome V recall — FDA Z-1274-2026

Devices which did not undergo thermoforming could deform and lose performance.

Class IIFDA: OngoingOlympus Corporation of the Americas

Medical DeviceFeb 11, 2026

Olympus Corporation of the Americas Single Use 3-Lumen Sphincterotome V (Distal Wire guided) recall — FDA Z-1280-2026

Devices which did not undergo thermoforming could deform and lose performance.

Class IIFDA: OngoingOlympus Corporation of the Americas

Medical DeviceFeb 11, 2026

Single Use Electrosurgical Knife Olympus Single Use Electrosurgical Knife KD-640L recall — FDA Z-1222-2026

A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.

Class IIFDA: OngoingOlympus Corporation of the Americas

Medical DeviceFeb 11, 2026

Olympus Corporation of the Americas Single Use 3-Lumen Sphincterotome V (Distal Wire guided) recall — FDA Z-1279-2026

Devices which did not undergo thermoforming could deform and lose performance.

Class IIFDA: OngoingOlympus Corporation of the Americas

Medical DeviceFeb 11, 2026

Olympus Corporation of the Americas Single Use 3-Lumen Sphincterotome V recall — FDA Z-1292-2026

Devices which did not undergo thermoforming could deform and lose performance.

Class IIFDA: OngoingOlympus Corporation of the Americas

Understanding this recall history

This page summarizes recall records in which the official source identifies Olympus Corporation of the Americas as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.

Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.