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Lower risk Medical device recall · FDA · Published May 25, 2021

Medline Cotton Rounds Recall: Mold Risk from Aspergillus Vadensis

Medline recalls cotton rounds due to potential mold contamination (Aspergillus vadensis). Affected products include Beauty 360 and Simply Soft brands. Stop using if mold is present.

🇺🇸 FDA recall #Z-2080-2021Medical deviceMedline ›
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Recalling firmMedline Industries Inc3 Lakes Dr · Northfield, IL 60093-2753
✎ GovInfoNow plain-language explainer

What happened, in plain English

Medline is recalling cotton rounds and pads that may contain mold (Aspergillus vadensis). This mold can cause health issues if inhaled or touched, especially for people with weakened immune systems. The recall covers specific brands and counts sold in the U.S. and Canada. Read more at govinfonow.com/recall/62486-medline-cotton-rounds-recall-mold-risk-from-aspergillus-vadensis.

Source Summary by GovInfoNow · govinfonow.com/recall/62486-medline-cotton-rounds-recall-mold-risk-from-aspergillus-vadensis · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2080-2021

Cite this page

“Medline Cotton Rounds Recall: Mold Risk from Aspergillus Vadensis.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62486-medline-cotton-rounds-recall-mold-risk-from-aspergillus-vadensis. Based on FDA recall #Z-2080-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2080-2021%22&limit=1).

Why it’s dangerous

The cotton rounds may contain Aspergillus vadensis mold, which can cause health problems if inhaled or touched. This mold is common in damp environments and can grow on cotton products over time.

Who’s affected

People who own or use the recalled cotton rounds, especially those with weakened immune systems or sensitive skin. The risk is low for most users but higher for those with health conditions.

How to tell if you have this one

Check for products with the brand names Beauty 360 or Simply Soft, and counts like 80, 100, or 240. The recall includes specific catalog numbers listed in the notice.

  • Brand
    Medline
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check for Mold

    Inspect the cotton rounds for visible mold growth, which may appear as fuzzy patches or discoloration.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 22 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: nationwideWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: named in the noticeCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: nationwideNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: named in the noticeALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Nationwide Distribution to states of: AL, AR, AZ, CA, CO, DC, FL, IA, IL, IN, MD, MI, MN, MO, NJ, NY, OH, PA, RI, SC, TN, TX, and VA; International to country of: Antigua.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, District of Columbia, Florida, Illinois, Indiana, Iowa, Maryland, Michigan, Minnesota, Missouri, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia.

Recall timeline

FDA terminated this recall 21 months after the firm started it.

1. Firm started the recall: May 25, 202112. FDA classified it Class II: Jul 16, 202123. Published in FDA’s Enforcement Report: Jul 28, 202134. FDA terminated the recall: Feb 27, 2023420212023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

✎ GovInfoNow

Questions people ask

What products are recalled?

Beauty 360 Extra Large Premium Cotton Ovals (100 count), Beauty 360 Premium Cotton Rounds (240 count), Beauty 360 Patterned Basic Cotton Rounds (80 count), Beauty 360 Premium Cotton Rounds (80 count), Medline non-sterile Cotton Rounds (80 count), Simply Soft Cotton Rounds (30 count), Simply Soft Premium Cotton Rounds (80 count), and W Textured Cotton Rounds (240 count).

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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-2080-2021 (May 25, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2080-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 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