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FUJIFILM

FUJIFILM CORPORATION · Model DC-07D · UDI-DI 04547410330663

FDT Prescription

510(k) clearances

24,099

Adverse events (186 deaths)

Recalls

Facilities

Description

This product is a distal end rubber cap required to be attached to certain FUJFIILM endoscopes during clinical use to assist in providing atraumatic passage of the endoscope tip during endoscopic procedures. Do not use this product for any other purposes.

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.