Medline recalls medical procedure kits containing Neuro Sponges with higher-than-expected endotoxin levels, which could be out-of-specification for endotoxin. Affected kits include SPINE PROCEDURES PACK-LF and others with specific kit numbers and lot numbers.
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 could mean the products are out-of-specification for endotoxin, though the risk to users is not described as causing serious injury.
During an internal review, Medline found higher-than-expected endotoxin levels on a representative Neuro Sponge product. Endotoxins are bacterial components that can cause infections if introduced into the body, but the recall indicates the product may be out-of-specification for endotoxin levels.
Healthcare professionals and medical facilities that use Medline's Neuro Sponges in spinal procedures or urology robotic kits. The highest risk is for those using the specific kits with the listed lot numbers.
Check if your Medline medical procedure kit has the following labels: SPINE PROCEDURES PACK-LF (kit number DYNJ0751220P), ENSEMBLE RACHIS-LF (kit number DYNJ47568B), or UROLOGY ROBOTIC (kit numbers DYNJ55555B, DYNJ55555C, DYNJ55555D). Also check the lot numbers listed in the recall.
Look for the specific kit labels and lot numbers listed in the recall to determine if your product is affected.
The recall indicates higher-than-expected endotoxin levels, which could mean the product is out-of-specification for endotoxin. However, the recall does not state that this poses a risk of serious injury or illness.
The recall does not specify a remedy, so there is no action required beyond checking if your kit is affected.
Check if your kit has the specific labels and lot numbers listed in the recall, such as SPINE PROCEDURES PACK-LF with kit number DYNJ0751220P or ENSEMBLE RACHIS-LF with kit number DYNJ47568B.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2034-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2034-2026 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.
