Medline recalls specific procedure kits with masks that didn't meet EN 14683 bioburden standards. Affected kits include Short Term Infusaport Access Kit (reorder DYNDC3188) sold with lot numbers 2024040390-2024100790.
Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops, and SOFT TOUCH II Surgical Masks which were subsequently recalled for not meeting the bioburden testing requirements of EN 14683.
Medline is recalling procedure kits that include surgical masks which failed bioburden testing standards. This means the masks might not be safe for medical use, potentially leading to infections if used improperly.
The masks in these kits were manufactured to not meet EN 14683 bioburden testing requirements. This means they might not effectively prevent infection during medical procedures, increasing the risk of contamination.
Healthcare workers using Medline procedure kits with the specific reorder number DYNDC3188 and listed lot numbers are most at risk. Patients receiving care from these kits could also be affected.
Check for procedure kits labeled as Short Term Infusaport Access Kit with reorder number DYNDC3188. Look for lot numbers 2024040390, 2024051490, 2024070590, or 2024100790.
Look for the reorder number DYNDC3188 and lot numbers 2024040390-2024100790 on the kit packaging.
The masks failed bioburden testing requirements for EN 14683, meaning they might not prevent infection during medical procedures.
The recall record does not specify a remedy, so contact Medline directly for guidance.
No, the masks were not tested to meet EN 14683 standards, which could increase infection risk during medical procedures.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1041-2025 — Medline Medline Hello, I own a Medline that is covered by recall Z-1041-2025 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
