Medline Industries, LP is a leading provider of medical supplies, equipment, and products. We offer a wide range of healthcare products for hospitals, clinics, and medical professionals.
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 Industries, LP is a leading provider of medical supplies, equipment, and products. We offer a wide range of healthcare products for hospitals, clinics, and medical professionals.
The product is a medical device that is generally safe for use in healthcare settings. However, it is important to follow proper usage guidelines and ensure that the device is used in accordance with the manufacturer's instructions.
All healthcare professionals and medical facilities
Check the product's UDI/DI, case number, and lot number for each item to ensure proper traceability and safety.
Verify the UDI/DI and lot number for each product to ensure it matches the information provided on the product label.
Ensure that the product is used in accordance with the manufacturer's instructions for use.
Report any adverse events or issues to the appropriate regulatory body or the manufacturer.
UDI/DI (Unique Device Identification/Device Identifier) is a unique code assigned to medical devices to ensure traceability and safety.
Check the product's UDI/DI, case number, and lot number to ensure it matches the information provided on the product label.
Report any adverse events or issues to the appropriate regulatory body or the manufacturer.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2021-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2021-2026 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.
