SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System recalled due to Staphylococcus aureus, USA

United States

Ascent Consumer Products Inc. is voluntarily recalling one lot of SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System to the consumer level. The recall is being initiated due to a confirmed test result of microbial contamination of the product with Staphylococcus aureus (S. aureus). The affected lot was distributed in January 2025 nationwide through retail and online outlets.

Risk Statement: Use of the SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System, contaminated with S. aureus, can result in blood infections in users whose nasal mucosa may be compromised due to inflammation and mechanical injuries, caused by nasal irrigation. Resulting secondary infections may occur, 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. These infections are serious and potentially life-threatening.

SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System is used as a nasal wash of the nasal passages to help temporarily relieve symptoms associated with sinusitis, cold, flu, or allergies. The only affected product lot includes the following:

- Product Name: SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System
- Lot Number: 024122661A1
- Expiration Date: 12-31-2027

The SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System is packaged in a carton, containing the squeeze bottle and 30 Saline Packets. The lot number and expiration date can be identified on the side of the carton or on the back of the Saline Packets within the carton.

Ascent Consumer Products Inc. is informing its distributors and customers via email about the recall. Distributors and retailers with the affected lot should stop distribution immediately and remove it from their inventory. Consumers who have this product are advised to stop using it right away and either return it to the place of purchase or dispose of it.

If you are experiencing symptoms after eating this product it is important to report it. It can help to detect & resolve outbreaks early and prevent others from being harmed, and it enables better surveillance. If symptoms persist seek medical attention.

Company name: Ascent Consumer Products Inc.
Brand name: SinuCleanse
Product recalled: Soft Tip Squeeze Bottle Nasal Wash System
Reason of the recall: Microbial contamination of the product with Staphylococcus aureus (S. aureus)
FDA Recall date: February 25, 2025

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ascent-consumer-products-inc-issues-voluntary-nationwide-recall-sinucleanse-soft-tip-squeeze-bottle