Z-2080-2021Class II

Cotton Rounds/Pads under the following brand names: 1. BEAUTY 360 Extra Large Premium Cotton Ovals - two...

Name: Z-2080-2021 Cotton Rounds/Pads under the following brand names: 1. BEAUTY 360 Extra Large Premium Cotton Ovals - two...
Creator: Medline Industries Inc
Published: 2021-05-25
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2021-05-25 / Terminated / root cause: manufacturing process

FDA source

Medline Industries Inc began a recall of 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... on 2021-05-25. FDA classified it as Class II and gives the reason as "Potential for mold contamination (Aspergillus vadensis)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2080-2021
Classification: Class II
Status: Terminated
Initiated: 2021-05-25
Posted: 2021-07-16
Terminated: 2023-02-27
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
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.
Product code: FRL Fiber, Medical, Absorbent
Reason for recall: Potential for mold contamination (Aspergillus vadensis)
Root cause tag: manufacturing process
FDA 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 [email protected] 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 in commerce: 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.
Product codes and lots: LOT 5602010 Catalog numbers : CVS217106V2, CVS362443V1, CVS362120V1, CVS365244V1, RSS10009, RSS10010, MDS21468, and WRX271818

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2080-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2080-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-28	2021-07-16

Product code FRL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)