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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

Fujifilm Medical Systems U.S.A., Inc.: This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.

Agency Publication Date: May 31, 2016
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Affected Products

Product: Endoscope; ED-530XT Operation Manual 'Operation and Preparation' and 'Cleaning, Disinfection and Storage'

All distribution dates :3/2003-4/2016

Product: Endoscope ED-250XL5 Operations Manual: Cleaning, Disinfection

All distribution dates :3/2003-4/2016

Product: Endoscope ED-250XT5 Operations Manual: Cleaning Disinfection and Storage

All distribution dates :3/2003-4/2016

Product: Endoscope ED-450XT5 Operation Manual: Cleaning, Disinfection and Storage

All distribution dates :3/2003-4/2016

Product: Endoscope ED-450XL5 Operation Manual: Cleaning, Disinfection and Storage

All distribution dates :3/2003-4/2016

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 73469
Status: Resolved
Manufacturer: Fujifilm Medical Systems U.S.A., Inc.
Manufactured In: United States
Units Affected: 5 products (1473 units; 98 units; 882 units; 484 units; 94 units)

Were You Affected by This Recall?

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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 · 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.