Multiple Brands of Cotton Pads Recalled for Mold Contamination Risk
Medline Industries is recalling multiple brands of cotton pads and rounds due to potential mold contamination. The affected products were distributed nationwide and internationally for use in cosmetic and personal care applications.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall with potential mold contamination (Aspergillus vadensis). No illnesses or injuries have been reported. Per the rubric, theoretical hazards without reported illness have a maximum severity of 3 (High), as the contamination is potential rather than confirmed.
Plain-English summary
Medline Industries Inc is recalling multiple brands of cotton rounds and pads due to potential contamination with Aspergillus vadensis, a type of mold. The affected products include BEAUTY 360 Extra Large Premium Cotton Ovals, BEAUTY 360 Premium Cotton Rounds, BEAUTY 360 Patterned Basic Cotton Rounds, Medline non-sterile Cotton Rounds, Simply Soft Cotton Rounds, Simply Soft Premium Cotton Rounds, and W Textured Cotton Rounds. A total of 214,035 cases have been distributed.
The recalled products were marketed for application of cleansers and astringents, removal of makeup and nail polish, and cleaning superficial cuts and scrapes. The potential for mold contamination poses a health risk, as exposure to Aspergillus species can cause respiratory issues or infections.
The affected products were distributed nationwide to the following states: Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Florida, Iowa, Illinois, Indiana, Maryland, Michigan, Minnesota, Missouri, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, and Virginia. The products were also distributed internationally to Antigua. Lot number 5602010 is involved, with multiple catalog numbers.
Consumers who have purchased these products should stop using them immediately. Those with concerns about exposure should contact their healthcare provider. For more information, consumers can refer to the FDA's official recall notice.
The recalled product
- 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…
- Manufacturer
- Medline Industries Inc
- Affected units
- 214,035
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- LOT 5602010 Catalog numbers : CVS217106V2
- CVS362443V1
- CVS362120V1
- CVS365244V1
- RSS10009
- RSS10010
- MDS21468
- and WRX271818
Distribution
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