Medline recalls medical procedure kits with Neuro Sponges due to higher-than-expected endotoxin levels, which may indicate out-of-specification product. Affected kits have specific lot numbers and SKUs.
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 containing Neuro Sponges because internal testing found higher-than-expected endotoxin levels in some products. This could mean the kits don't meet safety standards for medical use, potentially causing infections or other complications if used improperly.
Endotoxins are natural components in bacterial cell walls that can cause infections when introduced into the body. Higher-than-expected levels in the sponges may lead to infections if the products are used in medical procedures without proper sterilization.
Healthcare professionals and medical facilities using the recalled Medline Neuro Sponges in procedure kits are most at risk. Patients using these kits could face infection risks if the sponges are contaminated.
Check for Medline kits labeled 'NEURO PACK' or 'CRANIO/NEURO/SPINE' with specific lot numbers: 26ABM977, 25KBM387, 25IBG995, 25GBW704, 26AMF231, or 25GMC304. The kit numbers/SKUs are DYNJ64479, DYNJ901072D, or DYNJ86657A and DYNJT3270.
Look for the specific lot numbers and kit numbers/SKUs listed in the recall notice to determine if your product is affected.
Medline identified higher-than-expected endotoxin levels in some Neuro Sponges during an internal review, indicating the products may not meet safety specifications.
Check the kit labels for the specific lot numbers and SKUs listed in the recall notice to see if your product is affected. If it is, you should stop using it and contact Medline for further instructions.
Higher endotoxin levels could potentially cause infections if the sponges are not properly sterilized during medical procedures.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2013-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2013-2026 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.