Medline recalls specific robotic hysterectomy procedure kits due to higher-than-expected endotoxin levels on neuro sponges, which may not meet safety standards.
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 certain robotic hysterectomy procedure kits that contain neuro sponges with higher-than-expected endotoxin levels. This could mean the products don't meet safety standards for medical use.
During internal testing, Medline found higher-than-expected endotoxin levels on some neuro sponges. Endotoxins are natural components of bacteria that can cause infections if they enter the body during surgery. The recall indicates these sponges may not meet safety standards for medical procedures.
Healthcare professionals using Medline's robotic hysterectomy kits with specific kit numbers and lot numbers listed in the recall. Patients undergoing surgery with these kits may be at risk if the sponges are used improperly.
Check for kit numbers DYNJ904269B, DYNJ904269C, or DYNJ904269D with specific lot numbers listed in the recall. These kits are labeled for robotic hysterectomy procedures.
Identify the kit number (DYNJ904269B, DYNJ904269C, or DYNJ904269D) on the product label.
Check the lot number on the product label, which is listed in the recall for specific kits.
Medline identified higher-than-expected endotoxin levels on a representative neuro sponge product during internal review, indicating the product may be out-of-specification for endotoxin.
The endotoxins could potentially cause infections if the sponges enter the body during surgery, but the recall is based on the product not meeting safety standards.
No, the recall does not require immediate discontinuation; healthcare professionals should check the kit numbers and lot numbers to determine if their product is affected.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2035-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2035-2026 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.
