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PENTAX Medical

HOYA CORPORATION · Model ED34-i10T2 · UDI-DI 04961333247455

FDT Prescription

510(k) clearances

25,157

Adverse events (187 deaths)

Recalls

Facilities

Description

PENTAX Medical Video Duodenoscope ED34-i10T2

Recalls

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

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.