Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–8 of 8 recalls
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.…