Karl Storz Endoscopy has recalled 105 units of various surgical instruments, including cutters, resectors, and burrs, because holes were found in the inner barrier of the product packaging. These devices are used in surgical procedures and were distributed nationwide across 15 states and internationally to Canada and Germany. Compromised packaging may allow the sterile instruments to become contaminated before use. There have been no reported incidents or injuries related to this recall.
The holes detected in the sterile barrier system can compromise the sterility of the surgical instruments. If these non-sterile tools are used during a procedure, they could introduce bacteria or other contaminants into a patient's body, posing a risk of infection.
Material Number: 28208BKS
Material Number: 28206CBS
Material Number: 28205NDS
Material Number: 20205FDS
Material Number: 28205HES
Material Number: 28205GDS
Material Number: 28208IDS
Material Number: 28205HDS
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 ยท Raw API Response
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