Data Foundry

Medical device recalls 2021

Cotton Rounds/Pads under the following brand names: 1 — Class II medical device recall Z-2080-2021

Terminated recall by Medline Industries Inc, reported 2021-07-28, distributed nationwide. Potential for mold contamination (Aspergillus vadensis)

Recall numberZ-2080-2021
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmMedline Industries Inc, Northfield, IL, United States
Recall initiated2021-05-25
Classified2021-07-16
Reported by FDA2021-07-28
Terminated2023-02-27
DistributedNationwide (US)
Quantity214,035 cases
Reason classesmicrobial contamination
Pathogensmold
Lot numbers5602010
Model numbersCVS217106V2, CVS362120V1, CVS362443V1, CVS365244V1, MDS21468, RSS10009, RSS10010, WRX271818

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)

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2080-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.