Soft Tip Squeeze Bottle Nasal Wash System

  • Microbial contamination of the product with Staphylococcus aureus (S. aureus)
  • Company: Ascent Consumer Products Inc.
  • Drugs
  • FDA
  • February 25, 2025

Product details

  • Soft Tip Squeeze Bottle Nasal Wash System

Company announcement

Ascent Consumer Products Inc. is voluntarily recalling one lot of SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System due to microbial contamination.

The product is contaminated with Staphylococcus aureus (S. aureus).

The affected lot was distributed nationwide in January 2025 through retail and online outlets. No adverse events have been reported to date.

Risk:

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.

Impacted states: Nationwide

Products:

- SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System

Contact

For more information, email cs@ascentconsumerproducts.com.

View the original FDA notice

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