Erbe USA Inc. has recalled approximately 40,952 Flexible Cryoprobes used in surgical procedures because the probes may rupture or burst during activation. This defect affects three different models of the flexible probes, including those sold with oversheaths. Consumers should be aware that this is a voluntary, firm-initiated recall distributed nationwide across the United States and Puerto Rico.
The probes may rupture or burst while being used during surgery, which could lead to internal injury or surgical complications for the patient. No specific injuries have been reported in the recall notice, but the risk level is classified as critical.
STERILEEO. For surgical use
For surgical use
For surgical use
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.