Lumicell, Inc. is recalling 200 units (20 packs) of its 900-00218 Sterile Cover 10-Pack Shipper Box Assemblies, which are components of the Lumicell Direct Visualization System (DVS). The recall was initiated because the elastic bands included in the kits may detach or fracture during surgical procedures. The manufacturer notified affected customers via email starting in July 2025.
If the elastic bands break or detach while a surgeon is working, pieces of the band could be left inside the patient's surgical cavity. This poses a serious risk of retained foreign bodies, which can lead to surgical site infections.
Component of Lumicell Direct Visualization System (DVS) / PMA # P230014
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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