The FDA has posted 8 enforcement recalls of flexible/rigid duodenoscope and accessories devices since 2025, none of them Class I (most serious). Most recent report: Jul 15, 2026.
Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.
Potential sterile breach of the pouches in which devices are packaged.
Potential sterile breach of the pouches in which devices are packaged.
Potential sterile breach of the pouches in which devices are packaged.
Potential sterile breach of the pouches in which devices are packaged.
Potential sterile breach of the pouches in which devices are packaged.
Potential sterile breach of the pouches in which devices are packaged.
Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF duodenoscope reprocessing.…
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Duodenoscope And Accessories, Flexible/Rigid”). Informational only — verify against the FDA before acting.