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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

Karl Storz Endoscopy: Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

Agency Publication Date: May 10, 2022
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Affected Products

Product: 11001RD1 11001RDK1 KARL STORZ Slim Nasopharyngolaryngoscope 96216006US V5.0 (10-2018)

11001RD1 11001RDK1 KARL STORZ Slim Nasopharyngolaryngoscope 96216006US V5.0 (10-2018) UDI Code: 0408551225608 All Serial Numbers manufactured/distributed since January 2018

Lot Numbers:
0408551225608
Product: 11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)

11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019) UDI Code: 04048551225738 All Serial Numbers manufactured/distributed since January 2018

Lot Numbers:
04048551225738

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89881
Status: Active
Manufacturer: Karl Storz Endoscopy
Manufactured In: United States
Units Affected: 2 products (All Serial Numbers manufactured/distributed since January 2018)

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.