🔍 RecallPedia

EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190

Class I - Dangerous
🏥 Medical Devices Recalled: October 31, 2024 Olympus Corporation of the Americas Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    Model Number: GIF-1TH190; UDI: 04953170343360, 04953170437014; Serial Number Range: Before 2446103 or After 2500453
  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:
High-level disinfection ("HLD") with Acecide-C disinfectant in the Olympus OER-Pro Automated Endoscope Reprocessor ("AER") has been removed as a compatible reprocessing method from the Instructions for Use when reprocessing the GIF-1THI90 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE ( GIF-1TH190 ).
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190

Product Codes/Lot Numbers:

Model Number: GIF-1TH190; UDI: 04953170343360, 04953170437014; Serial Number Range: Before 2446103 or After 2500453

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0620-2025

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