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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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Low RiskFDA Device

Aesculap Implant Systems LLC: The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable.

Agency Publication Date: April 11, 2018
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Affected Products

Product: Doyen-Collin Mouth Gag 120MM/ General Instruments

OM040R

Product: Strauss Penis Clamp 130MM/General Instruments

EF401R

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 79656
Status: Resolved
Manufacturer: Aesculap Implant Systems LLC
Manufactured In: United States

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.