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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Olympus EVIS EXERA III Gastrointestinal Videoscopes Recalled for Updated Instructions

Agency Publication Date: November 20, 2024
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Summary

Olympus Corporation of the Americas is recalling 1,749 EVIS EXERA III Gastrointestinal Videoscopes (model GIF-1TH190) to provide updated drying instructions. This recall follows a safety evaluation which found that the original drying steps could be misunderstood, potentially leading to human error during the cleaning process. No injuries have been reported at this time.

Risk

If the gastrointestinal scope is not dried correctly, moisture could remain in the device, allowing bacteria to grow or causing the equipment to fail. This poses a potential risk of infection to patients or may cause equipment failure during medical procedures.

What You Should Do

  1. This recall involves the Olympus EVIS EXERA III Gastrointestinal Videoscope (model GIF-1TH190) with serial numbers less than 2446103.
  2. Stop using the recalled device and ensure all medical staff are aware of the updated drying procedures provided in the revised Instructions for Use documentation.
  3. Contact Olympus Corporation of the Americas or your authorized medical equipment distributor to arrange for the return, replacement, or correction of the device.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this medical device recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190
Model / REF:
GIF-1TH190
Serial Numbers:
Less than 2446103
UDI:
04953170343360

This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, and other ancillary equipment for endoscopy.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95600
Status: Active
Manufacturer: Olympus Corporation of the Americas
Sold By: Authorized medical equipment distributors
Manufactured In: United States
Units Affected: 1749 units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.