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aBox Duodeno

Ambu A/S · Model 485001000US · UDI-DI 05707480145362

FDT Prescription
1
510(k) clearances
24,099
Adverse events (186 deaths)
38
Recalls
36
Facilities

Description

aBox Duodeno

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 reprocessing. Olymp
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, perforation, or obstru
2023-09-27Boston Scientific CorporationPoor 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.