Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 28, 2021
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 Cott
Potential for mold contamination (Aspergillus vadensis)
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medline Industries Inc recalled Cotton Rounds/Pads under the following brand names: 1. BEAUTY 360 Extra Large Premium C… - a moderate-severity action.
Cotton Rounds/Pads under the following brand names: 1. BEAUTY 360 Extra Large Premium C… was recalled by Medline Industries Inc in July 28, 2021. Reason: Potential for mold contamination (Aspergillus vadensis). Check the official notice for the remedy. Verify recall #Z-2080-2021 with the FDA Devices before acting.
The recall
Medline Industries Inc issued this moderate-severity FDA Devices recall-Potential for mold contamination (Aspergillus vadensis).
- Moderate
- severity level
- Class II
- classification
- July 28, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2080-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2080-2021) was formally reported on July 28, 2021, with the manufacturer initiating the action on May 25, 2021. It is classified under Moderate severity (Class II), with a current status of Terminated. Medline Industries Inc is listed as the recalling firm, operating out of Northfield, IL. Federal records list the affected scope as 214,035 cases.
The documented reason for this recall is: Potential for mold contamination (Aspergillus vadensis) Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
214,035 cases
Related Recalls
6
3 from same agency
Product description
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)
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2080-2021 |
| Date reported | July 28, 2021 |
| Date initiated | May 25, 2021 |
| Recalling firm | Medline Industries Inc |
| Firm location | Northfield, IL |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2080-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Medline Industries Inc. Units affected: 214,035 cases.
Why was this product recalled? ▼
Potential for mold contamination (Aspergillus vadensis)
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 28, 2021. Severity: Moderate. Recall number: Z-2080-2021.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2080-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 28, 2021. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.