Medline recalls medical procedure kits containing Neuro Sponges with higher-than-expected endotoxin levels. Products may be out-of-specification for endotoxin. Check kit numbers and lot numbers listed to see if your product is affected.
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Medline is recalling medical procedure kits that contain Neuro Sponges with higher-than-expected endotoxin levels. This means the products may not meet safety standards for endotoxin levels. If you have any of these kits, you should check the product details to see if they are affected.
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Neuro Sponge product. Endotoxins are natural components of bacterial cell walls that can cause infections if present in high concentrations. However, the hazard is not described as causing immediate injury or serious health risks in normal medical use.
Healthcare professionals and medical facilities that use Medline medical procedure kits containing Neuro Sponges. The risk is low as the hazard is related to endotoxin levels, which are typically not a direct health risk in normal use.
Check if your Medline medical procedure kit has a label indicating one of the listed kit numbers (e.g., CDS840402AI, CDS984890V) and the corresponding lot number (e.g., 23JLA668). The kits are sold with specific lot numbers and UDI/DI codes.
Identify your Medline medical procedure kit by checking the label for the kit number (e.g., CDS840402AI) and lot number (e.g., 23JLA668) listed in the recall notice.
Medline identified higher-than-expected endotoxin levels on a representative Neuro Sponge product, indicating the products may be out-of-specification for endotoxin.
Check the label on your Medline medical procedure kit for the kit number (e.g., CDS840402AI) and lot number (e.g., 23JLA668) listed in the recall notice.
The recall notice does not specify a remedy, so you should check with Medline directly for guidance.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2016-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2016-2026 from Medline. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
