On Tuesday, Ascent Consumer Products Inc. of New York issued a recall of their SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System. The FDA attributes the recall to possible product contamination with the bacteria Staphylococcos aureus.
The SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System is marketed as a nasal rinse for people struggling with allergies or illness-related congestion. Customers can mix the contents of one saline packet with eight fluid ounces of purified or distilled water. Positive pressure pushes the fluid through the nasal passages, clearing the sinuses of debris and excess mucous.
The recall includes lot 024122661A1 of the SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System. Ascent Consumer Products distributed the recalled lot in January 2025 via retailers and online channels throughout the United States. The expiration date for the affected product is 12-31-2027. The product is packaged in a green cardboard box with white and blue lettering. The front label includes the product name and describes the product as providing “Instant Relief” for “Nasal Congestion, Sinus Symptoms, and Allergies.” The box features a picture of both the soft tip squeeze bottle and the saline packets. Each box contains 30 saline packets. Customers can find the lot number and expiration date printed on the back of the product carton or on each individual saline packet.
As of February 25th, Ascent Consumer Products Inc. has not received any reports of illness or injury linked to the recalled product. The company initiated the recall after at least one sample from the recalled lot tested positive for contamination with Staphylococcus aureus. According to the CDC, 30% of people carry this bacteria in their nasal passages. In such instances, the bacteria is typically harmless. Introducing Staphylococcus aureus to the nasal membranes can be dangerous, however, for those with weakened immune systems or in people with inflamed or compromised nasal mucosa. In these instances, using a nasal rinse that has been contaminated with Staphylococcus aureus could cause the bacteria to enter the bloodstream. A blood infection could cause serious complications, such as “endocarditis (infection of the heart’s inner lining), bone and joint infections, splenic abscesses or meningitis, and bacterial sinusitis which may lead to eye tissue infections, vision problems, cranial nerve damage, or meningitis” (FDA).
Ascent Consumer Products Inc. advises customers who have purchased the affected lot of their SinuCleanse system to stop use of the product immediately. Customers can return the product to the point of purchase for a full refund.
Anyone with questions or concerns about the recall can contact Ascent Consumer Products Inc. Monday through Friday from 9 a.m. to 5 p.m. EST at cs@ascentconsumerproducts.com.
Patients and health care providers can report any new adverse health events related to use of the SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System through the FDA’s MedWatch Online Voluntary Reporting Form.
If you or a loved one has suffered an injury or adverse health outcome linked to safety issues with an over-the-counter medication or healthcare product, we urge you to get in touch with our team. It’s vital that the liable parties be held accountable for their negligence to prevent the further distribution of dangerous medications and products to retailers in the United States. Our experienced attorneys at TruLaw are prepared to learn about your story and help you begin building a case for just compensation. Contact us today or try out our free Instant Case Evaluation ℠ to get started.