Medline recalls medical procedure kits with Neuro Sponges labeled SPINE PACK-LF due to higher-than-expected endotoxin levels, potentially causing infections. 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 labeled SPINE PACK-LF because tests found higher-than-expected endotoxin levels. This could lead to infections if used in medical procedures.
Endotoxins are natural components of bacteria that can cause infections when introduced into the body. Higher-than-expected levels in these sponges could increase infection risk during medical procedures.
Healthcare professionals using Medline Neuro Sponges in medical procedures are most at risk. Patients receiving these sponges during surgery may be affected if the sponges are contaminated.
Check for kits labeled SPINE PACK-LF with specific lot numbers: 22GBF198, 22DBU132, 22ABJ303, 21GBV167, 21GBV186, 21BBL371. The kit number SKU PHS719414B and UDI/DI numbers 10889942214112 (single) or 40889942214113 (case) are also indicators.
Look for the label 'SPINE PACK-LF' on the medical procedure kit.
Medline identified higher-than-expected endotoxin levels in some Neuro Sponges during an internal review, indicating the product may be out-of-specification.
Lot numbers 22GBF198, 22DBU132, 22ABJ303, 21GBV167, 21GBV186, and 21BBL371 are affected.
The recall does not require immediate stop use; however, affected kits should be checked and disposed of if they match the specified labels and lot numbers.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2012-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2012-2026 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.
