Medline recalls spinal fusion procedure kits with neuro sponges that may have high endotoxin levels, potentially causing infections. Affected kits include 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 spinal fusion procedure kits that contain neuro sponges with higher-than-expected endotoxin levels. This could lead to infections if used in medical procedures. The recall affects specific lot numbers and SKUs.
Endotoxins are natural components of bacterial cell walls that can cause infections when introduced into the body. Higher-than-expected levels in the neuro sponges may increase infection risk during medical procedures.
Healthcare professionals using Medline spinal fusion kits with the listed lot numbers and SKUs are most at risk. Patients receiving procedures with these kits may also be affected.
Check the kit label for 'SPINAL FUSION, Medline Kit' and the specific lot numbers: 25LBI308, 25JBH227, 25HBQ371, 25HBP069, 25GBQ494, 25FBM672, 25CBF603, 25BBG224, 25ABN190, 25ABN214.
Look for the label 'SPINAL FUSION, Medline Kit' and the specific lot numbers listed in the recall.
Medline identified higher-than-expected endotoxin levels in a representative neuro sponge product, indicating the in-market product may be out-of-specification for endotoxin.
The recall does not specify a remedy, so check the kit label for the listed lot numbers and contact Medline if you have the affected products.
Higher endotoxin levels could potentially increase infection risk during medical procedures, but the recall does not indicate a risk of serious injury.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2011-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2011-2026 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.
