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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

Aizu Olympus Co., Ltd.: EVIS EXERA III Video Gastroscopes and Colonoscopes Recalled for Repair Defect

Agency Publication Date: November 29, 2023
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Summary

Aizu Olympus Co., Ltd. has recalled 120 units across several models of EVIS EXERA III Video Gastroscopes and Colonoscopes because specific units may have been improperly repaired. These devices may be missing the adhesive required to secure the suction channel mouthpiece to the scope connector, which can cause a loss of image, decreased suction, or the inability to properly clean and disinfect the device between uses. Consumers should contact their healthcare provider or the manufacturer to determine if their specific device is one of the 24 incorrectly repaired units and to arrange for corrective action.

Risk

The missing adhesive can lead to device failure during a procedure or prevent effective sterilization, potentially exposing patients to contaminated material and subsequent infection or causing unanticipated delays in treatment.

What You Should Do

  1. Identify if your facility possesses any of the affected models: CF-HQ190L, GIF-H190, GIF-HQ190, PCF-H190DL, or PCF-H190L.
  2. Check the specific UDI-DI and Serial Numbers on your devices to see if they match the affected units: for CF-HQ190L (UDI-DI 04953170305115, Serial 2635812 or 2416423), for GIF-H190 (UDI-DI 04953170305290, Serials 2515895, 2312905, 2628532), for GIF-HQ190 (UDI-DI 04953170305276, Serials 2270393, 2201027, 2201611, 2745407), for PCF-H190DL (UDI-DI 04953170363672, Serials 2942716, 2604497, 2502056), and for PCF-H190L (UDI-DI 04953170305191, Serials 2302719, 2516751).
  3. Contact your healthcare provider or Olympus directly to confirm your device's status and receive instructions on returning the unit for proper repair.
  4. If you are a patient who has recently undergone a procedure with one of these devices and have concerns, contact your healthcare provider for further guidance.
  5. For additional questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Correction of improper repair

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

Affected Products

Product: CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE
Model / REF:
CF-HQ190L
UPC Codes:
04953170305115
Lot Numbers:
Serial Number 2635812
Serial Number 2416423
Product: GIF-H190 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
Model / REF:
GIF-H190
UPC Codes:
04953170305290
Lot Numbers:
Serial Number 2515895
Serial Number 2312905
Serial Number 2628532
Product: GIF-HQ190 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
Model / REF:
GIF-HQ190
UPC Codes:
04953170305276
Lot Numbers:
Serial Number 2270393
Serial Number 2201027
Serial Number 2201611
Serial Number 2745407
Product: PCF-H190DL EVIS EXERA III COLONOVIDEOSCOPE
Model / REF:
PCF-H190DL
UPC Codes:
04953170363672
Lot Numbers:
Serial Number 2942716
Serial Number 2604497
Serial Number 2502056
Product: PCF-H190L EVIS EXERA III COLONOVIDEOSCOPE
Model / REF:
PCF-H190L
UPC Codes:
04953170305191
Lot Numbers:
Serial Number 2302719
Serial Number 2516751

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93335
Status: Active
Manufacturer: Aizu Olympus Co., Ltd.
Sold By: Authorized Medical Distributors
Manufactured In: Japan
Units Affected: 5 products (24 incorrectly repaired units)
Distributed To: Florida, Kentucky, Massachusetts, New Jersey, New York, Pennsylvania

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.