🔍 RecallPedia

Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.

Class I - Dangerous
🏥 Medical Devices Recalled: February 12, 2026 Olympus Corporation of the Americas Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Model Number: N3058140. UDI-DI: 04953170258589. Catalog Number: N3058140. All Lot/Serial Numbers.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Olympus Corporation of the Americas
Reason for Recall:
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.

Product Codes/Lot Numbers:

Model Number: N3058140. UDI-DI: 04953170258589. Catalog Number: N3058140. All Lot/Serial Numbers.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1613-2026

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