The Sjögren’s Foundation remains dedicated to the safety of Sjögren’s patients and providing you with the information you need to make important health decisions.
On February 25, 2025, the FDA issued a nationwide voluntary recall of SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System (Lot: 024122661A1; Expiration: 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 affected lot was distributed in January 2025 nationwide through retail and online outlets.
The product manufactured by Ascent Consumer Products, Inc. was recalled for a confirmed test result of microbial contamination with Staphylococcus aureus (S. aureus).
Consumers who have this product should discontinue use immediately and return it to the place of purchase or discard it. Contact your physician or healthcare provider if you experience any problems related to the use of this product.
Potential Health Risks
Using SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System contaminated with S. aureus is a bacteria that can cause blood infections in users whose nasal membrane may be compromised due to inflammation and injuries caused by nasal irrigation. Secondary infections can occur, including endocarditis (infection of the heart's inner lining), bone and joint infections, eye tissue infections leading to vision problems, cranial nerve damage, or meningitis (inflammation to the membranes that line the brain and spinal cord). S. aureus infections are serious and potentially life-threatening. There have been no adverse events related to this recall reported to Ascent Consumer Products, Inc. to this date.
Symptoms of S. Aureus Infection
- Fever
- Chills
- Fatigue
- Joint pain
- Muscle aches
- Nausea and vomiting
- Diarrhea
- Toxic shock syndrome: sudden drop in blood pressure, high fever, rash, and organ failure
Product Reporting
Consumers with questions regarding this recall can contact Ascent Consumer Products, Inc. by email at cs [at] ascentconsumerproducts [dot] com (cs[at]ascentconsumerproducts[dot]com) Monday-Friday from 9am-5pm ET. For more information, you can visit the statement released by Ascent Consumer Products, Inc. or visit the recall notice on the FDA website.
Reporting Adverse Reactions
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online
- Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
The Sjögren’s Foundation remains dedicated to the safety of Sjögren’s patients and providing you with the information you need to make important health decisions.
On February 25, 2025, the FDA issued a nationwide voluntary recall of SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System (Lot: 024122661A1; Expiration: 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 affected lot was distributed in January 2025 nationwide through retail and online outlets.
The product manufactured by Ascent Consumer Products, Inc. was recalled for a confirmed test result of microbial contamination with Staphylococcus aureus (S. aureus).
Consumers who have this product should discontinue use immediately and return it to the place of purchase or discard it. Contact your physician or healthcare provider if you experience any problems related to the use of this product.
Potential Health Risks
Using SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System contaminated with S. aureus is a bacteria that can cause blood infections in users whose nasal membrane may be compromised due to inflammation and injuries caused by nasal irrigation. Secondary infections can occur, including endocarditis (infection of the heart's inner lining), bone and joint infections, eye tissue infections leading to vision problems, cranial nerve damage, or meningitis (inflammation to the membranes that line the brain and spinal cord). S. aureus infections are serious and potentially life-threatening. There have been no adverse events related to this recall reported to Ascent Consumer Products, Inc. to this date.
Symptoms of S. Aureus Infection
Product Reporting
Consumers with questions regarding this recall can contact Ascent Consumer Products, Inc. by email at cs [at] ascentconsumerproducts [dot] com (cs[at]ascentconsumerproducts[dot]com) Monday-Friday from 9am-5pm ET. For more information, you can visit the statement released by Ascent Consumer Products, Inc. or visit the recall notice on the FDA website.
Reporting Adverse Reactions
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.