Changeflow GovPing Healthcare Olympus MAJ-1443 Endoscope Suction Valve Recall...
Priority review Enforcement Added Final

Olympus MAJ-1443 Endoscope Suction Valve Recall - Reprocessing Incompatibility

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Filed April 1st, 2026
Detected April 7th, 2026
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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

  1. Identify MAJ-1443 and MAJ-1444 valve inventory and verify compatibility status with OER-Pro or OER-Elite reprocessors
  2. Discontinue use of affected valves if compatibility with OER-Pro or OER-Elite reprocessors cannot be confirmed
  3. 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

Source

Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
FDA
Filed
April 1st, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Minor
Document ID
Class II Z-1610-2026

Who this affects

Applies to
Healthcare providers Medical device makers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Medical Device Manufacturing
Geographic scope
United States US

Taxonomy

Primary area
Medical Devices
Operational domain
Clinical Operations
Compliance frameworks
FDA 21 CFR Part 11
Topics
Healthcare Product Safety

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