🔍 RecallPedia

Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA III Duodenovideoscope TJF-Q190V; Item code: Catalogue #N5786100

Class I - Dangerous
🏥 Medical Devices Recalled: April 18, 2023 Olympus Corporation of the Americas Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI-DI: 04953170403019; Item code: Catalog N5786100 Lots Lower than H2530
  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 Single Use Distal Cover MAJ-2315 may cause mucosal injury and/or become detached from the endoscope during use. Consequences of a detached cover could include the risk of aspiration, inhalation, or obstruction that will require urgent removal, and/or burns from an uncovered distal end.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA III Duodenovideoscope TJF-Q190V; Item code: Catalogue #N5786100

Product Codes/Lot Numbers:

UDI-DI: 04953170403019; Item code: Catalog N5786100 Lots Lower than H2530

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1613-2023

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