United StatesOlympus endoscope suction valve (Model MAJ-1443, Catalog N5363430, UDI‑DI 04953170355912), air/water valve (Model MAJ-1444, Catalog N5363530, UDI‑DI 04953170355929), and endoscope reprocessors OER‑Elite (Model N5789340, Catalog N5789340, UDI‑DI 04953170404047) and OER‑Pro (Model N3058140, Catalog N3058140, UDI‑DI 04953170258589) are recalled. The MAJ-1443 and MAJ-1444 valves are no longer reprocessing compatible with the OER‑Pro and OER‑Elite automated endoscope reprocessors.
What's being recalled
Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.
Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.
Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.
Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA, United States.
How to identify it
Model Number: MAJ-1443. UDI-DI: 04953170355912. Catalog Number: N5363430. All Lot/Serial Numbers. Model Number: MAJ-1444. UDI-DI: 04953170355929. Catalog number: N5363530. All Lot/Serial Numbers. Model Number: N5789340. UDI-DI: 04953170404047. Catalog number: N5789340. All Lot/Serial Numbers. Model Number: N3058140. UDI-DI: 04953170258589. Catalog Number: N3058140. All Lot/Serial Numbers.
The hazard
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)