Karl Storz Endoscopy is recalling approximately 11,466 injection needles and cannulas used in general and visceral surgery. The manual cleaning process for these reusable devices cannot be guaranteed to be effective, which may leave biological material on the needles. This defect affects multiple models including various Luer-lock, curved, and angular needles. If the devices are not properly cleaned between uses, they can expose patients to a significantly higher risk of infection during surgical procedures.
The complex design of these needles prevents manual cleaning from reaching all surfaces effectively. This can lead to the retention of biological contaminants from previous patients, potentially causing serious cross-contamination or systemic infections in subsequent patients.
Manufacturer notification and coordination for affected devices.
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.
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 · 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.