Ascent Consumer Products Inc. has initiated a voluntary nationwide recall of its SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System due to confirmed contamination with Staphylococcus aureus (S. aureus), a bacterium that can cause severe and potentially life-threatening infections.
Affected Product: SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System
Lot Number: 024122661A1
Expiration Date: December 31, 2027
Distribution: The affected lot was distributed nationwide in January 2025 through various retailers, including Walgreens, H-E-B, and Amazon.
The contamination was identified following routine testing, which detected the presence of S. aureus in the product.
This bacterium, commonly found on the skin and in the nasal passages, can lead to serious health issues if introduced into the body, especially in individuals with compromised nasal mucosa due to inflammation or injury.
Potential infections include endocarditis (infection of the heart’s inner lining), bone and joint infections, splenic abscesses, meningitis, and bacterial sinusitis, which may further lead to eye tissue infections, vision problems, cranial nerve damage, or meningitis.
No adverse health events related to this recall have been reported as of now.
However, consumers of the affected product are strongly advised to discontinue its use immediately and either return it to the place of purchase or dispose of it appropriately.
Distributors and retailers have been instructed to cease distribution and remove the recalled lot from their inventories.
For any questions or concerns regarding this recall, consumers can contact Ascent Consumer Products Inc. via email at cs@ascentconsumerproducts.com, Monday through Friday, from 9 a.m. to 5 p.m. ET.
Those who have experienced health issues related to the use of this product should consult their healthcare provider promptly.
Adverse reactions or quality problems can also be reported to the FDA’s MedWatch Adverse Event Reporting program.
This recall underscores the importance of ensuring the sterility of medical devices, especially those intended for nasal irrigation, to prevent potential health risks associated with microbial contamination.
