Medline Industries, LP has recalled 5,559 craniotomy kits that contain a specific surgical tool known as the Integra Lifesciences Codman Disposable Perforator (14 mm). These surgical kits, used during brain procedures, contain perforators with inadequate welds that may break or separate during use. No injuries have been reported at this time, but the manufacturer has initiated a voluntary recall of affected lots distributed across 13 states.
A perforator with a weak weld can break or come apart during surgery. This can lead to surgical delays, unintended injury to the brain, or pieces of the device being left inside the patient.
Hospital/Clinical Device Correction
Recall #: Z-1809-2025
Recall #: Z-1810-2025
Recall #: Z-1811-2025
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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