SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System recalled over sterility concerns

Recall date

January 28, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Ascent Consumer Products Inc. recalls SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg),…

Recall number

D-0299-2025

FDA classification

Class I

Brand / firm

Ascent Consumer Products Inc.

Sold / distributed

Nationwide in the US.

Why it was recalled

Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 Soft tip Squeeze Bottle, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00104 1