Olympus Corporation of the Americas recalls 47,383 MAJ-1443 and MAJ-1444 endoscope suction valves distributed nationwide in the United States. The valves are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. Hospitals and clinics should stop using the valves 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 suction valves MAJ-1443 and MAJ-1444 are components used with Olympus reprocessing equipment to clean and sterilize endoscopes. They are intended to be compatible with OER-Pro and OER-Elite systems.
The valves are no longer reprocessing compatible with the specified reprocessors, which may compromise sterilization when used in routine reprocessing cycles.
This recall is not described as part of a broader industry pattern in the provided data.
Hospitals and clinics may need to adjust reprocessing workflows or obtain replacement valves to ensure proper sterilization. No injuries have been reported to date.
UDI-DI on product packaging; Catalog Number on label on the device or packaging.
Timeline for refunds or replacements is not specified in the recall notice.
Keep the recall letter, model numbers MAJ-1443/MAJ-1444, UDI-DI 04953170355912, Catalog Number N5363430, and all correspondence with Olympus.
Model numbers: MAJ-1443 and MAJ-1444. Sold in the United States via nationwide distribution. Sold date and price not disclosed. Quantity: 47,383 units. Catalog Number: N5363430. UDI-DI: 04953170355912. All Lot/Serial Numbers affected.
No injuries or incidents have been reported.
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