Karl Storz Endoscopy is recalling 285 units of its Optical Biopsy and Grasping Forceps (model REF 723400) because the manual cleaning process for the devices could not be validated. This sterility assurance failure means the tools may not be properly cleaned between uses, which could expose patients to a risk of infection. While no injuries have been reported, healthcare providers are advised to stop using the devices and contact the manufacturer to arrange for their return or correction.
The failure of cleaning validation means that biological material or harmful bacteria could remain on the forceps even after manual cleaning. This creates a significant risk of cross-contamination and infection for patients undergoing medical procedures with these instruments.
Recall number: Z-0837-2025; Also identified as material number 04048551194416.
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.
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Sources: FDA iRES · Raw API Response
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