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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: Olympus Gastrointestinal Videoscopes Recalled for Incorrect Color Correction

Agency Publication Date: October 23, 2024
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Summary

Olympus Corporation of the Americas is recalling 1,407 units of the Olympus Gastrointestinal Videoscope (Model GIF-1100). The recall was initiated after performance testing revealed that the imaging sensors were programmed with incorrect color correction data, meaning the devices do not meet their required technical specifications. Consumers should contact their healthcare provider or Olympus for further instructions regarding this equipment.

Risk

Incorrect color correction data in the imaging sensors can result in inaccurate visual representations during medical procedures, potentially leading to diagnostic errors or difficulty in identifying anatomical features. No specific injuries or incidents have been reported in the current data.

What You Should Do

  1. Identify if your facility uses the Olympus Gastrointestinal Videoscope, Model/Catalog Number GIF-1100.
  2. Check the serial number on the device or its packaging to see if it matches any of the affected units, such as 2304049, 2404551, 2404550, 2404541, 2404537, or any of the hundreds of others listed in the recall documentation.
  3. Verify the Unique Device Identifier (UDI-DI) code 04953170420191 printed on the product labeling.
  4. Contact your healthcare provider or Olympus Corporation of the Americas directly for further instructions regarding the inspection or repair of the affected videoscopes.
  5. For additional questions, contact the FDA at 1-888-463-6332 or visit the FDA website at www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer corrective action

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

Affected Products

Product: Olympus Gastrointestinal Videoscope
Model / REF:
GIF-1100
UPC Codes:
04953170420191
Lot Numbers (1407):
2304049
2404551
2404550
2404541
2404537
2404577
2404576
2404574
2404571
2404570
2404569
2404568
2404567
2404566
2404565
2404564
2404563
2404562
2404561
2404560
2404559
2404552
2404547
2404626
2404625
2404624
2404623
2404620
2404619
2404618
2404617
2404616
2404615
2404614
2404613
2404612
2404611
2404610
2404609
2404608
2404607
2404606
2404605
2404604
2404603
2404601
2404599
2404598
2404602
2404600

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95421
Status: Active
Manufacturer: Olympus Corporation of the Americas
Sold By: Authorized Olympus medical equipment distributors
Manufactured In: United States
Units Affected: 1407 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.