FDA Recall of Olympus Endoscope Air/Water Valve MAJ-1444
The FDA has announced a recall of 89,579 units of Olympus Endoscope Air/Water Valve due to incompatibility with specific reprocessors, affecting nationwide distribution.
What Happened
Olympus Corporation of the Americas is recalling the Olympus Endoscope Air/Water Valve because the MAJ-1443 and MAJ-1444 models are no longer compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Which Products Are Affected
The affected product is the Olympus Endoscope Air/Water Valve - MAJ-1444, with model number MAJ-1444. It includes UDI-DI: 04953170355929, catalog number: N5363530, and all lot/serial numbers. A total of 89,579 units are involved, distributed nationwide in the United States. The recall number is Z-1611-2026.
What You Should Do
Consumers and users with the affected product should contact Olympus Corporation of the Americas for further instructions, as the recall was initiated via letter. The firm is located at 3500 Corporate Pkwy, Center Valley, PA 18034-8229.
Why This Matters
This recall involves a medical device used in healthcare settings, potentially affecting patient safety due to reprocessing issues, and impacts a large number of units across the United States.
Source
This information is from the FDA recall notice, event ID 98371.
Source: FDA Official Notice