FDA Device recall Z-1611-2026
Olympus Endoscope Air/Water Valve - MAJ-1444
- FDA Device
- Class II
- ongoing
- Published 2026-04-01
On 2026-04-01 the FDA classified a Class II recall of Olympus Endoscope Air/Water Valve - MAJ-1444 by Olympus, citing the MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1611-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-02-12 |
| Published | 2026-04-01 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Olympus |
| Distribution | US |
Product
Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.
Reason
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Identifiers
| code_info | Model Number: MAJ-1444. UDI-DI: 04953170355929. Catalog number: N5363530. All Lot/Serial Numbers. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
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FDA Device · Class II · 2026-10-07 · Olympus - Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector
FDA Device · Class II · 2026-09-30 · Olympus - Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm
FDA Device · Class II · 2026-09-30 · Olympus
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1611-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.