Olympus MAJ-1443 Endoscope Suction Valve Recall - Reprocessing Incompatibility
Summary
Olympus Corporation of the Americas issued a Class II recall for MAJ-1443 Endoscope Suction Valves. The recall addresses compatibility issues where MAJ-1443 and MAJ-1444 valves no longer work with OER-Pro and OER-Elite automated endoscope reprocessors. Distribution covers US Nationwide.
What changed
Olympus Corporation of the Americas initiated Class II recall Z-1610-2026 for MAJ-1443 and MAJ-1444 Endoscope Suction Valves. The compatibility issue prevents these valves from functioning properly with OER-Pro and OER-Elite automated endoscope reprocessors. This is a nationwide distribution recall affecting healthcare facilities using Olympus endoscope equipment.
Healthcare providers should immediately identify affected valve inventory and discontinue use if compatibility with OER-Pro or OER-Elite reprocessors is required. Providers should follow FDA recall communications and manufacturer guidance for return or replacement procedures. This is an ongoing recall with no specified return deadline provided in the notice.
What to do next
- Identify MAJ-1443 and MAJ-1444 valve inventory and verify compatibility status with OER-Pro or OER-Elite reprocessors
- Discontinue use of affected valves if compatibility with OER-Pro or OER-Elite reprocessors cannot be confirmed
- Monitor FDA recall communications and follow manufacturer instructions for return or replacement
Source document (simplified)
Olympus Corporation of the Americas
Device Recalls (Class II)
← All Device Recalls (Class II) Class II Z-1610-2026 · 20260401 · Ongoing
Product
Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.
Reason for Recall
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Distribution
US Nationwide distribution.
Source: openFDA Enforcement API
Related changes
Source
Classification
Who this affects
Taxonomy
Browse Categories
Get Healthcare alerts
Weekly digest. AI-summarized, no noise.
Free. Unsubscribe anytime.
Get alerts for this source
We'll email you when FDA: Device Recalls Class II publishes new changes.