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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

Shirakawa Olympus Co., Ltd.: Medical Scopes Recalled for Updated Manual Cleaning Instructions

Agency Publication Date: January 9, 2024
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Summary

Olympus is recalling approximately 20,869 medical scopes, including various bronchoscopes and cystoscopes, because the instructions for manual cleaning have changed. The company has determined that reusable cleaning brushes should no longer be used for manual cleaning of these devices, although single-use brushes remain safe and compatible. This update is critical to ensure the devices are properly disinfected between patient uses, as improper cleaning can lead to the spread of infections.

Risk

If reusable cleaning brushes are used instead of the now-required single-use brushes, the medical scopes may not be adequately cleaned or disinfected. This poses a risk of cross-contamination and the potential transmission of infections between patients during medical procedures.

What You Should Do

  1. Identify if your facility uses any of the affected Olympus models: CYF-5, CYF-5R, BF-P190, BF-XP190, ENF-XP, CYF-VH, CYF-VHR, CYF-V2, or CYF-V2R.
  2. Review the updated Instructions for Use (IFU) provided by Olympus regarding the removal of reusable cleaning brushes from the manual cleaning protocol.
  3. Immediately stop using reusable cleaning brushes for the manual cleaning of these specific scope models.
  4. Transition to using only compatible single-use cleaning brushes as specified in the updated manufacturer guidelines.
  5. Contact your healthcare provider or Olympus directly at 1-800-848-9024 for further instructions on receiving updated manuals or if you have questions about device reprocessing.
  6. For additional information or to report concerns, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manual instruction update

How to: Olympus has updated the instructions for use to remove reusable cleaning brushes from the manual cleaning protocol. Use only single-use brushes.

Affected Products

Product: Cystonephrofiberscope (Model CYF-5)
Model / REF:
CYF-5
UPC Codes:
04953170292323
04953170339417
04953170411144
Lot Numbers:
All serial numbers
Product: Cystonephrofiberscope (Model CYF-5R)
Model / REF:
CYF-5R
UPC Codes:
04953170328817
04953170411182
Lot Numbers:
All serial numbers
Product: EVIS EXERA III Bronchovideoscope (Model BF-P190)
Model / REF:
BF-P190
UPC Codes:
04953170342110
Lot Numbers:
All serial numbers
Product: EVIS EXERA III Bronchovideoscope (Model BF-XP190)
Model / REF:
BF-XP190
UPC Codes:
04953170342134
Lot Numbers:
All serial numbers
Product: RHINO-LARYNGOFIBERSCOPE (Model ENF-XP)
Model / REF:
ENF-XP
UPC Codes:
04953170059018
Lot Numbers:
All serial numbers
Product: CYSTO-NEPHRO VIDEOSCOPE (Model CYF-VH)
Model / REF:
CYF-VH
UPC Codes:
04953170310461
04953170411250
Lot Numbers:
All serial numbers
Product: CYSTO-NEPHRO VIDEOSCOPE (Model CYF-VHR)
Model / REF:
CYF-VHR
UPC Codes:
04953170310522
04953170411298
Lot Numbers:
All serial numbers
Product: VISERA Cysto-Nephro Videoscope (Model CYF-V2)
Model / REF:
CYF-V2
UPC Codes:
04953170287091
04953170339431
04953170411199
Lot Numbers:
All serial numbers
Product: VISERA Cysto-Nephro Videoscope (Model CYF-V2R)
Model / REF:
CYF-V2R
UPC Codes:
04953170339523
04953170411212
Lot Numbers:
All serial numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93583
Status: Active
Manufacturer: Shirakawa Olympus Co., Ltd.
Sold By: Authorized medical distributors; Direct sales to hospitals and clinics
Manufactured In: Japan
Units Affected: 9 products (3457 US; 8122 Global; 2551 US; 3738 Global; 2600 US; 3214 OUS; 1187 US; 1652 OUS; 1929 US; 2200 OUS; 4780 US; 10448 OUS; 1547 US; 2772 OUS; 2210 US; 6002 OUS; 608 US; 1264 OUS)
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.