Medline recalls neuro sponges with higher-than-expected endotoxin levels that may be out-of-specification. Affected products include specific sizes and SKUs sold from 2019-2020.
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 several types of neuro sponges due to higher-than-expected endotoxin levels detected in some products. This could mean the sponges don't meet safety standards for endotoxin content, though the recall doesn't indicate immediate health risks.
Endotoxins are natural components of bacterial cell walls that can cause inflammation or infection if they enter the body. The recall indicates that some Medline neuro sponges have higher-than-expected levels of these substances, which could potentially lead to infection or inflammation in rare cases.
Healthcare professionals and medical facilities that use these sponges are most likely affected. Patients using the sponges during procedures are at minimal risk if the sponges are used properly.
Check for product labels with sizes like 0.25" X 0.25", 0.5" X 0.5", or larger. Look for Medline SKUs NEUROSPNG02 through NEUROSPNG14. Products were sold from 2019 to 2020 with specific UDI/DI numbers listed in the recall.
Look for the product size and Medline SKU numbers listed in the recall to confirm if your sponges are affected.
Medline identified higher-than-expected endotoxin levels in some neuro sponges during an internal review, indicating the products may be out-of-specification for endotoxin.
The recall indicates potential for higher endotoxin levels, which could cause inflammation or infection in rare cases, but the recall does not specify immediate health risks.
Check for product labels with sizes like 0.25" X 0.25" through 1" X 3" and Medline SKUs NEUROSPNG02 through NEUROSPNG14. Products were sold from 2019 to 2020 with specific UDI/DI numbers listed in the recall.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2008-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2008-2026 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.
