Lower riskMedical device recall · FDA · Published February 12, 2026
Olympus Endoscope Suction Valve MAJ-1443: Not Compatible with Endoscope Reprocessors
Olymp: Olympus recalls endoscope suction valve model MAJ-1443 due to incompatibility with OER-Pro and OER-Elite reprocessors. Affected units may not function properly with these devices.
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
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Contact the company
📍Recalling firmOlympus Corporation of the Americas3500 Corporate Pkwy · Center Valley, PA 18034-8229
✎ GovInfoNow plain-language explainer
Olympus is recalling endoscope suction valves with model number MAJ-1443 because they are no longer compatible with certain endoscope reprocessors. This means the valves may not work correctly with OER-Pro and OER-Elite machines, potentially causing improper cleaning or infection risks. Read more at govinfonow.com/recall/50008-olympus-endoscope-suction-valve-maj-1443-not-compatible-with-endoscope.
“Olympus Endoscope Suction Valve MAJ-1443: Not Compatible with Endoscope Reprocessors.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/50008-olympus-endoscope-suction-valve-maj-1443-not-compatible-with-endoscope. Based on FDA recall #Z-1610-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1610-2026%22&limit=1).
Olympus Corporation of the Americas recalled Olympus Endoscope Suction Valve model MAJ-1443 due to reprocessing compatibility issues, according to the FDA on Feb. 12, 2026.
How to tell if you have it
Brand: Olympus
Product: Olympus Endoscope Suction Valve
Model Number: MAJ-1443
Catalog Number: N5363430
UDI-DI: 04953170355912
Lot/Serial Numbers: All Lot/Serial Numbers
The hazard
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Context
GovInfoNow's records show Olympus Corporation of the Americas has 133 other recalls on record since Aug. 18, 2017. Other recent recalls include Olympus Tripp-Lite P580-025 DisplayPort Cable (Aug. 27, 2026), Olympus M3 Gold Autoclavable Foroblique Telescope (Aug. 24, 2026), and Olympus BiCOAG Hemostasis Probe (Aug. 19, 2026). Other recent recalls of similar products include Boston Scientific Orca Air/Water Valves Recall (May 12, 2026) and Medline Recalls Olympus Biopsy Valves (Feb. 16, 2026).
How to tell if you have this one
Check for the model number MAJ-1443 on the suction valve. The product was sold with UDI-DI: 04953170355912 and catalog number N5363430. All lot/serial numbers are included in the recall.
Brand
Olympus
Category
Medical device
FDA recall event · 4 products
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
US Nationwide distribution.
Recall number
Product, codes & lots
Quantity
Z-1610-2026
Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.; Model Number: MAJ-1443. UDI-DI: 04953170355912. Catalog Number: N5363430. All Lot/Serial Numbers.
47,383 units
Z-1611-2026
Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.; Model Number: MAJ-1444. UDI-DI: 04953170355929. Catalog number: N5363530. All Lot/Serial Numbers.
89,579 units
Z-1612-2026
Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.; Model Number: N5789340. UDI-DI: 04953170404047. Catalog number: N5789340. All Lot/Serial Numbers.
2,929 units
Z-1613-2026
Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.; Model Number: N3058140. UDI-DI: 04953170258589. Catalog Number: N3058140. All Lot/Serial Numbers.
3,354 units
Based on the official FDA remedy
What to do — step by step
Check Compatibility
Verify if your suction valve model MAJ-1443 is compatible with OER-Pro or OER-Elite reprocessors.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 48 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1610-2026 (February 12, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1610-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.