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Lower risk Medical device recall · FDA · Published November 18, 2024

Medline procedure kits recalled for masks failing bioburden testing

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1042-2025Medical deviceMedline ›
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Contact the company

Recalling firmMEDLINE INDUSTRIES, LP - Northfield3 Lakes Dr · Northfield, IL 60093-2753
✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/53471-medline-procedure-kits-recalled-for-masks-failing-bioburden-testing.

Source Summary by GovInfoNow · govinfonow.com/recall/53471-medline-procedure-kits-recalled-for-masks-failing-bioburden-testing · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1042-2025

Cite this page

“Medline procedure kits recalled for masks failing bioburden testing.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53471-medline-procedure-kits-recalled-for-masks-failing-bioburden-testing. Based on FDA recall #Z-1042-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1042-2025%22&limit=1).

The FDA announced on 2024-11-18 that Medline Industries, LP is recalling certain Medline procedure kits because they contain masks that failed bioburden testing requirements. The agency issued recall number Z-1042-2025 for the voluntary Class II recall.

How to tell if you have it

  • Brand: Medline
  • Product: CENTRAL LINE DRESSING KIT, Reorder number DYNDC3189; dressing change tray
  • Reorder number: DYNDC3188
  • UDI/DI: 10653160348818 (each), 00653160348811 (case)
  • Lot Numbers: 2024030690, 2024041990, 2024082390
  • Units affected: 250 units

The hazard

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.

Context

GovInfoNow's records show MEDLINE INDUSTRIES, LP - Northfield has 119 other recalls on record since 2021-10-22. Other recent recalls of similar products include Medline medical kits recalled for light failure in newborn resuscitation kits (2025-07-25), Medline Recalls Foley Tray Kits with Incorrect Labeling Risk (2025-07-23), and Medline ReNewal Reprocessed St. Jude Catheters May Contain Particulates (2025-07-14). Other recent recalls of similar products include Medline medical procedure kits recalled for potential endotoxin levels (2026-03-19), Medline medical procedure kits with neuro sponges recalled for endotoxin levels (2026-03-19), and Medline medical procedure kits with high endotoxin levels recalled (2026-03-19).

How to tell if you have this one

Check for Medline procedure kits labeled as Central Line Dressing Kit (Reorder DYNDC3189) or other kits with specific lot numbers: 2024030690, 2024041990, 2024082390.

  • Brand
    Medline
  • Category
    Medical device
FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    US Nationwide distribution.
Recall numberProduct, codes & lotsQuantity
Z-1040-2025Medline procedure kits labeled as: 1) Port Access Kit, Reorder number CVI5130; 2) VANTEX 7FR 3L 20CM CVC STOCK+ BUNDLE US. Reorder number STCVC01USGV; general surgical tray; 1) CVI5130: UDI/DI 10653160372349 (each) 00653160372342 (case), Lot Numbers: 2024040490, 2024073190, 2024082790, 2024101790,; 2) STCVC01USGV: UDI/DI 10653160376965 (each) 00653160376968 (case), Lot Numbers: 2024050990.749 units
Z-1041-2025Medline procedure kits labeled as: 1) SHORT TERM INFUSAPORT ACCESS KIT, Reorder number DYNDC3188; surgery tray; 1) DYNDC3188: UDI/DI 10653160348825 (each) 00653160348828 (case), Lot Numbers: 2024040390, 2024051490, 2024070590, 2024100790.1450 units
Z-1042-2025Medline procedure kits labeled as: 1) CENTRAL LINE DRESSING KIT, Reorder number DYNDC3189; dressing change tray; 1) DYNDC3188: UDI/DI 10653160348818 (each) 00653160348811 (case), Lot Numbers: 2024030690, 2024041990, 2024082390.250 units
Based on the official FDA remedy

What to do — step by step

  1. Check Kit Labels

    Look for the specific reorder numbers and lot numbers listed in the recall notice to identify affected kits.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 3 months after the firm started it.

1. Firm started the recall: Nov 18, 202412. FDA classified it Class II: Jan 28, 202523. Published in FDA’s Enforcement Report: Feb 5, 2025320242025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

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.

  • Official source: FDA Recall #Z-1042-2025 (November 18, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1042-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA