Medline recalls certain procedure kits with masks that didn't meet EN 14683 bioburden standards. Affected kits include Central Line Dressing Kit (DYNDC3189) and others with specific lot numbers. Stop using immediately to avoid infection risks.
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 masks which failed bioburden testing. This means the masks might not meet safety standards for preventing infections during medical procedures.
The masks in these kits were manufactured without meeting the EN 14683 bioburden testing requirements. This means they might not effectively prevent infections during medical procedures, increasing the risk of contamination.
Healthcare workers using Medline procedure kits with the specified lot numbers and reorder codes are most at risk. Patients receiving care from these kits could also be affected.
Check for Medline procedure kits labeled as Central Line Dressing Kit (Reorder DYNDC3189) or other kits with specific lot numbers: 2024030690, 2024041990, 2024082390.
Look for the specific reorder numbers and lot numbers listed in the recall notice to identify affected kits.
The masks failed bioburden testing requirements for EN 14683, meaning they might not effectively prevent infections during medical procedures.
The recall record does not specify a remedy, so check with Medline directly for instructions.
Central Line Dressing Kit (Reorder DYNDC3189) and other kits with lot numbers 2024030690, 2024041990, or 2024082390.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1042-2025 — Medline Medline Hello, I own a Medline that is covered by recall Z-1042-2025 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.
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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.
