FDA Medical Device Recalls (openFDA)
Medline Industries Inc: 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.
- Recall number
- Z-2080-2021
- Recalling firm
- Medline Industries Inc
- 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.
- Status
- Terminated
- Initiated
- 2021-05-25
- Posted
- not on file
- Terminated
- 2023-02-27
- Reason
- Potential for mold contamination (Aspergillus vadensis)
- Root cause
- Process control
- Action
- On June 4, 2021 the firm sent "URGENT RECALL NOTIFICATION" letters to their consignees with the following instructions: REQUIRED ACTION: 1. Immediately check your stock for the affected item number and the affected lot number listed. Destroy all affected product 2. Please return the completed enclosed URGENT REMEDIAL ACTION RESPONSE FORM listing the quantity of affected product destroyed. Even if you do not have any affected product please complete and return the form via email to recalls@medline.com or fax to: 866-767-1290. When we receive your completed destruction form your account will receive credit, if applicable. 3. If you have transferred possession of this product to another individual, to another department or another location in your organization you are required by FDA regulations to notify them of this recall communication. If you have any questions, please contact 866-359-1704.
- Quantity
- 214,035 cases
- 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.
- Lot, serial or model codes
- LOT 5602010 Catalog numbers : CVS217106V2, CVS362443V1, CVS362120V1, CVS365244V1, RSS10009, RSS10010, MDS21468, and WRX271818
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FRL
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28