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Duodenoscope And Accessories, Flexible/Rigid

FDA product code FDT · Class 2 · Gastroenterology, Urology

76
Registered devices
24,099
Adverse events
38
Recalls
35
510(k) clearances

Devices with this code

FOOT RELEASE — OLYMPUS MEDICAL SYSTEMS CORP.LIGHTGUIDE CAP — OLYMPUS MEDICAL SYSTEMS CORP.SpyGlass Ocular — BOSTON SCIENTIFIC CORPORATIONPENTAX Medical — HOYA CORPORATIONSINGLE USE DISTAL COVER — OLYMPUS MEDICAL SYSTEMS CORP.Air/water valve — OLYMPUS MEDICAL SYSTEMS CORP.PENTAX — HOYA CORPORATIONFUJIFILM — FUJIFILM CORPORATIONVIDEO DUODENOSCOPE — PENTAX OF AMERICA, INC.FUJIFILM — FUJIFILM CORPORATIONCONNECTING TUBE — OLYMPUS MEDICAL SYSTEMS CORP.ULTRASONIC PROBE — OLYMPUS MEDICAL SYSTEMS CORP.CRE Wireguided — BOSTON SCIENTIFIC CORPORATIONN/A — PENTAX OF AMERICA, INC.CRE Wireguided — BOSTON SCIENTIFIC CORPORATIONVIDEO DUODENOSCOPE — PENTAX OF AMERICA, INC.ULTRASONIC PROBE — OLYMPUS MEDICAL SYSTEMS CORP.CRE Wireguided — BOSTON SCIENTIFIC CORPORATIONPENTAX Medical — HOYA CORPORATIONCRE Wireguided — BOSTON SCIENTIFIC CORPORATIONSINGLE USE DISTAL COVER — OLYMPUS MEDICAL SYSTEMS CORP.PENTAX Medical — HOYA CORPORATIONCRE Wireguided — BOSTON SCIENTIFIC CORPORATIONULTRASONIC PROBE — OLYMPUS MEDICAL SYSTEMS CORP.

Recent recalls

DateFirmReason
2026-06-05Olympus Corporation of the AmericasOlympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.
2026-05-21Boston Scientific CorporationPotential sterile breach of the pouches in which devices are packaged.
2026-05-21Boston Scientific CorporationPotential sterile breach of the pouches in which devices are packaged.
2026-05-21Boston Scientific CorporationPotential sterile breach of the pouches in which devices are packaged.
2026-05-21Boston Scientific CorporationPotential sterile breach of the pouches in which devices are packaged.
2026-05-21Boston Scientific CorporationPotential sterile breach of the pouches in which devices are packaged.
2026-05-21Boston Scientific CorporationPotential sterile breach of the pouches in which devices are packaged.
2025-10-14Olympus Corporation of the AmericasContinued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF duodenoscope
2023-12-08Olympus Corporation of the AmericasSingle Use Distal Cover MAJ-2315 may unexpectedly detach from the duodenoscope during use result include the risk of mucosal injury, tissue damage, bleeding, pe
2023-09-27Boston Scientific CorporationPoor image quality due to fluid ingress in the lens.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.