Integra LifeSciences Corp. is recalling approximately 623 units of its AURORA Surgiscope System, a sterile, single-use surgical device. The recall was initiated because the device's obturator—an internal component—may break or separate during use. This recall affects all unexpired lots of catalog numbers ASX15/60 and ASX15/80. While no injuries have been reported to date, a device failure during surgery could lead to serious medical complications.
If the obturator breaks during a surgical procedure, it may cause a procedural delay or leave fragments inside the patient, potentially requiring additional medical intervention to retrieve the separated piece. No incidents or injuries have been reported so far.
System contains a Sheath, Obturator, and Imager.
System contains a Sheath, Obturator, and Imager.
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
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