FDAClass II · Medical device · Recall Z-1900-2026 · Recalled April 29, 2026

OER-ELITE Endoscope Reprocessor Connecting Tubes recall — Olympus Corporation of the Americas

Agency report date: April 29, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: OER-ELITE Endoscope Reprocessor Connecting Tubes
Company / brand: Olympus of the Americas
Lot / serial / date codes: Model Number: MAJ-2112. UDI Number: 04953170404078. Lot Numbers: 09A, 0XA, 0YA, 0ZA, 11A, 12A, 21A, 22A, 23A, 24A, 25A, 26A, 27A, 28A, 29A, 2XA, 2YA, 2ZA, 31A, 32A, 33A, 34A, 35A, 36A, 37A, 38A, 39A, 3XA, 3YA, 3ZA, 41A, 42A, 43A, 44A, 45A, 46A, 47A, 48A, 49A, 4XA, 4YA, 4ZA, 51A.
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.

Agency product description and boundaries

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: OER-ELITE Endoscope Reprocessor Connecting Tubes

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-1900-2026
Brand: Olympus of the Americas
Classification: Class II
Units affected: 8,994 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

OER-ELITE Endoscope Reprocessor Connecting Tubes

Companies & origin

Recalling firm location: Center Valley, PA, United States
Firm address: 3500 Corporate Pkwy, N/A, 18034-8229

Identifying details (verbatim from the notice)

Product codes / lots: Model Number: MAJ-2112. UDI Number: 04953170404078. Lot Numbers: 09A, 0XA, 0YA, 0ZA, 11A, 12A, 21A, 22A, 23A, 24A, 25A, 26A, 27A, 28A, 29A, 2XA, 2YA, 2ZA, 31A, 32A, 33A, 34A, 35A, 36A, 37A, 38A, 39A, 3XA, 3YA, 3ZA, 41A, 42A, 43A, 44A, 45A, 46A, 47A, 48A, 49A, 4XA, 4YA, 4ZA, 51A.
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.
Firm notified the public via: Letter
FDA event ID: 98544
Recall initiated: March 25, 2026
FDA classified: April 22, 2026
FDA report date: April 29, 2026

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked September 7, 2026 at 6:00 AM UTC. Record retrieved July 28, 2026 at 11:00 PM UTC.

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