Olympus Corporation of the Americas is recalling 2,929 units of the OER-Elite Endoscope Reprocessor in the United States. The MAJ-1443 and MAJ-1444 modules are no longer reprocessing compatible with the OER-Pro and OER-Elite systems. Hospitals and healthcare providers should stop using the affected devices immediately and follow the recall instructions issued by Olympus.
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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The OER-Elite is an automated endoscope reprocessor used by healthcare facilities to clean and disinfect endoscopes between patients.
Incompatibility of MAJ-1443/MAJ-1444 with the OER-Pro and OER-Elite could compromise reprocessing efficacy, increasing infection risk.
This recall is not described as part of a broader industry pattern in the provided data.
Facilities may need to halt use of affected reprocessors and coordinate with Olympus for remediation, potentially impacting patient throughput and facility costs.
Recall notice and enforcement page linked in FDA recall reporting. Manufacturer communications and facility service records.
Remedy timelines are provided by Olympus in the recall notice; healthcare facilities should anticipate guidance within weeks.
Keep the recall notification, vendor communications, and service records. Photograph serial numbers and MAJ modules for records.
Model numbers: OER-Elite, N5789340. UDI-DI: 04953170404047. Catalog number: N5789340. All Lot/Serial Numbers. Distribution: US Nationwide distribution. Quantity: 2,929 units. Sold at: Not specified in recall notice. Price: Not specified.
No injuries or incidents have been reported.
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