CLASS II ONGOING Device recall · Reported 1 Apr 2026 · FDA Enforcement Report
Olympus Endoscope Air/Water Valve - MAJ recalled
Olympus Corporation of the Americas is recalling Olympus Endoscope Air/Water Valve - MAJ-1444, distributed nationwide in the US. The recall was initiated on 12 Feb 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1611-2026
- FDA event ID
- 98371
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Feb 2026
- FDA classified
- 20 Mar 2026
- Reported
- 1 Apr 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 12 Feb 2026 | Recall initiated by company | |
| 20 Mar 2026 | Classified by FDA | +36 days |
| 1 Apr 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Product as listed by the FDA
Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Which lots are affected?
Model Number: MAJ-1444. UDI-DI: 04953170355929. Catalog number: N5363530. All Lot/Serial Numbers.
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 98371This product is part of a recall event; the main page for the event is Olympus Endoscope Suction Valve - MAJ recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Olympus Endoscope Suction Valve - MAJ recalled | Olympus Corporation of the Americas | Other | Nationwide | |
| CLASS II | Olympus Endoscope Reprocessor OER-Pro recalled | Olympus Corporation of the Americas | Other | Nationwide | |
| CLASS II | Olympus Endoscope Reprocessor OER-Elite recalled | Olympus Corporation of the Americas | Other | Nationwide |
More recalls from Olympus Corporation of the Americas
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|---|---|---|---|---|---|
| Device | CLASS II | Olympus M3 Gold Autoclavable Lateral Telescope recalled | Olympus Corporation of the Americas | Sterility | PA |
| Device | CLASS II | Olympus Tripp-Lite P580-025 25ft DisplayPort Cable recalled | Olympus Corporation of the Americas | Other | Nationwide |
| Device | CLASS II | Olympus M3 Gold Autoclavable Foroblique Telescope recalled | Olympus Corporation of the Americas | Sterility | PA |
| Device | CLASS II | Olympus BiCOAG Hemostasis Probe Fixed Pin Connector recalled | Olympus Corporation of the Americas | Other | Nationwide |
| Device | CLASS II | Olympus BiCOAG Hemostasis Probe Coaxial Connector recalled | Olympus Corporation of the Americas | Other | Nationwide |
Other Surgical Instruments recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Adaptable Beach Chair Beach Chair surgical patient positioner recalled | Quantum OPS | Device Malfunction | Nationwide |
| Device | CLASS II | Laparoscopic Prostatectomy kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Halyard Laparoscopy Comprehensive Pack II recalled | GRI Medical & Electronic Technology | Other | Nationwide |
| Device | CLASS II | Gyn Laparoscopy/Laparotomy kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Gyn Laparoscopy Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |