Olympus endoscope suction valve no longer compatible with named reprocessors
Olympus is recalling the MAJ-1443 Endoscope Suction Valve because the MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: a reusable patient-contact component can no longer be validly reprocessed in the named systems, and no injuries are stated.
Plain-English summary
Olympus Corporation of the Americas is recalling the Olympus Endoscope Suction Valve, model MAJ-1443. About 47,383 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 04953170355912 and catalogue number N5363430.
Facilities can identify affected valves by the model number and UDI above, and may contact Olympus Corporation of the Americas for further information.
The recalled product
- Product
- Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscopy
- Affected units
- 47,383
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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