Olympus Corporation of the Americas is recalling 89,579 MAJ-1444 endoscope air/water valves distributed nationwide in the United States. The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. Healthcare facilities should stop using the devices immediately and follow the manufacturer’s recall instructions.
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Olympus Corporation of the Americas or your healthcare provider for instructions. Notification method: Letter
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Endoscope air/water valves are components used in cleaning and functioning of endoscopes in medical settings. They are used during endoscopic procedures and reprocessing workflows.
If the valve is not compatible with OER-Pro or OER-Elite reprocessors, proper cleaning and disinfection could be compromised, potentially increasing infection risk.
This recall is not described as part of a broader industry pattern in the provided data.
Hospitals may need to halt certain reprocessing steps for affected valves and await guidance from Olympus or the FDA. No injuries have been reported to date.
UDI-DI and catalog numbers are printed on device labels and packaging.
Remediation timeline not specified; expect manufacturer guidance and potential replacement or disposal instructions within weeks.
Keep recall notice, model numbers, UDI-DI, catalog number, and all correspondence with Olympus for records.
Model numbers: MAJ-1444 and MAJ-1443. UDI-DI: 04953170355929. Catalog number: N5363530. All Lot/Serial Numbers. Distribution: US Nationwide. Brand: Olympus Corporation of the Americas. Sold since: Unknown. Price: Unknown.
No injuries or incidents have been reported.
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