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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/Diagnostic Equipment

Olympus Corporation of the Americas: Gastrointestinal Videoscopes Recalled for Inadequate Sterilization Drying Time

Agency Publication Date: November 9, 2023
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Summary

Olympus is recalling 1,687 units of the EVIS EXERA III Gastrointestinal Videoscope (Model GIF-1TH190) because the device's reprocessing manual does not provide enough drying time for the endoscope channel. If the device is not dried correctly during sterilization, it can lead to sterilization failure and the presence of moisture which may harbor bacteria. This issue affects all serial numbers of this specific model distributed nationwide. Consumers should contact Olympus or their healthcare provider for further guidance on ensuring these devices are safe for use.

Risk

Inadequate drying time during the sterilization process can lead to the survival of microorganisms or the growth of bacteria within the endoscope channels, potentially causing infections in patients during subsequent medical procedures.

What You Should Do

  1. Identify if your facility uses the EVIS EXERA III Gastrointestinal Videoscope by checking for Model Number GIF-1TH190 and UDI-DI 04953170343360 on the device or packaging.
  2. Be aware that this recall affects all serial numbers for the GIF-1TH190 model.
  3. Contact Olympus Corporation of the Americas at 1-800-848-9024 or visit their website to obtain updated reprocessing instructions or information regarding the necessary drying times for these devices.
  4. Consult with your healthcare provider or clinical engineering department to ensure that all sterilization protocols for these specific videoscopes are updated to prevent sterilization failures.
  5. For any additional questions or to report concerns, contact the FDA directly at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

manufacturer or healthcare provider Consultation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: EVIS EXERA III Gastrointestinal Videoscope
Model / REF:
GIF-1TH190
UDI-DI: 04953170343360
Lot Numbers:
All Serial Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93212
Status: Active
Manufacturer: Olympus Corporation of the Americas
Sold By: Olympus Corporation of the Americas
Manufactured In: United States
Units Affected: 1687 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.