PlainRecalls
FDA Drug Verify with FDA Drug → Critical Class I Ongoing

SinuCleanse Soft Tip NETI POT Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 kettle style Neti Pot, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00102 7

Reported: April 2, 2025 Initiated: January 28, 2025 #D-0301-2025 unknown units

The recall

Ascent Consumer Products Inc. issued this critical-severity FDA Drug recall — Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus.

Critical
severity level
unknown
units affected
Class I
classification
April 2, 2025
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-0301-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Drug action (record #D-0301-2025) was formally reported on April 2, 2025, with the manufacturer initiating the action on January 28, 2025. It is classified under Critical severity (Class I), with a current status of Ongoing. Ascent Consumer Products Inc. is listed as the recalling firm, operating out of Melville, NY. Federal records indicate unknown units are affected.

The documented reason for this recall is: Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus Distribution data in the federal record shows the product reached: Nationwide in the US.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC and NHTSA going back to 1995. Within the same product category, the database holds 6 closely related recalls. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 1 year old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.

Where this recall sits in the database

Severity2119858883High severity (most serious)Moderate severityLow severity
Where this recall sits in the database

Of 83,949 recalls in the database, 21,198 are high severity, 58,883 moderate, and 3,868 low. This recall is classified high severity.

Severity

Critical

Units Affected

unknown

Related Recalls

6

0 from same agency

Product Description

SinuCleanse Soft Tip NETI POT Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 kettle style Neti Pot, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00102 7

Reason for Recall

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

Details

Units Affected
unknown
Distribution
Nationwide in the US.
Location
Melville, NY

Recall Profile

Structured summary of the FDA Drug recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Critical (Class I)
Status Ongoing
Recall number D-0301-2025
Date reported April 2, 2025
Date initiated January 28, 2025
Recalling firm Ascent Consumer Products Inc.
Units affected unknown
Distribution Nationwide in the US.

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

Frequently Asked Questions

What product was recalled?
SinuCleanse Soft Tip NETI POT Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 kettle style Neti Pot, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00102 7. Recalled by Ascent Consumer Products Inc.. Units affected: unknown.
Why was this product recalled?
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Which agency issued this recall?
This recall was issued by the FDA Drug on April 2, 2025. Severity: Critical. Recall number: D-0301-2025.
Where was the recalled product distributed?
Distribution: Nationwide in the US..
How do I check if my product is affected by a recall?
Check the product description and recall number (D-0301-2025) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Recall Context

Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as critical severity, meaning the product carries a reasonable probability of serious adverse health consequences or death. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.

Nearby Recalls in This Category

Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.

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Data Sources

Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.

  • Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
  • Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
  • Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
  • Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

All federal data sources used on this page
  • U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
  • BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
  • BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
  • U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
  • IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
  • data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov

Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).