FDA (Devices) recall action 98371
The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Olympus is recalling the MAJ-1444 Endoscope Air/Water Valve because the MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Olympus is recalling the OER-Pro Endoscope Reprocessor because the MAJ-1443 and MAJ-1444 air/water valves are no longer reprocessing compatible with the OER-Pro and OER-Elite reprocessors.
Olympus is recalling the OER-Elite Endoscope Reprocessor because the MAJ-1443 and MAJ-1444 air/water valves are no longer reprocessing compatible with the OER-Pro and OER-Elite reprocessors.
Olympus is recalling the MAJ-1443 Endoscope Suction Valve because the MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.