# FDA recall Z-2080-2021

> **Medline Industries Inc** · Class II · device recall initiated 2021-05-25.

## Product

Cotton Rounds/Pads under the following brand names:   1. BEAUTY 360 Extra Large Premium Cotton Ovals - two textures soft and strong 100 count;  2. BEAUTY 360 Premium Cotton Rounds - two textures soft and strong 240 count;  3. BEAUTY 360 Patterned Basic Cotton Rounds - multipurpose 80 count;  4. BEAUTY 360 Premium Cotton Rounds - two textures soft and strong 80 count;  5. Medline non-sterile Cotton Rounds 80 count;  6. Simply Soft Cotton Rounds - Trial Size 30 counts;  7. Simply Soft Premium Cotton Rounds  80 Count; and   8. W Textured Cotton Rounds 240 Count.     For application of cleansers and astringents, and the removal of makeup and nail polish; for cleaning superficial cuts and scrapes and applying medication to the skin.

## Reason for recall

Potential for mold contamination (Aspergillus vadensis)

## 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.

## Key facts

- **Recall number:** Z-2080-2021
- **Recalling firm:** Medline Industries Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-05-25
- **Report date:** 2021-07-28
- **Termination date:** 2023-02-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Northfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2080-2021

## Citation

> AI Analytics. FDA recall Z-2080-2021. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/Z-2080-2021. Source: US FDA. Licensed CC0.

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