Olympus OER-Pro reprocessor no longer compatible with two valve models
Olympus is recalling the OER-Pro Endoscope Reprocessor because the MAJ-1443 and MAJ-1444 air/water valves are no longer reprocessing compatible with the OER-Pro and OER-Elite reprocessors.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: reusable patient-contact valves can no longer be validly reprocessed in this system, and no injuries are stated.
Plain-English summary
Olympus Corporation of the Americas is recalling the Olympus Endoscope Reprocessor OER-Pro, model N3058140. About 3,354 units were distributed nationwide in the United States. The FDA has classified this recall as Class II.
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
All lot and serial numbers are affected. The device carries UDI-DI 04953170258589.
Facilities can identify affected reprocessors by the model number and UDI above, and may contact Olympus Corporation of the Americas for further information.
The recalled product
- Product
- Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 3,354
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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