Ascent Consumer Products Inc.
FDA Regulatory Profile
Ascent Consumer Products Inc. appears in FDA public data with 3 recalls — including 3 Class I (most serious) —, 1 510(k) clearance, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (D-0300-2025, Class I) was initiated on January 28, 2025. Its most recent 510(k) clearance was granted on September 12, 2019.
Summary
- Total Recalls
- 3 (3 Class I)
- 510(k) Clearances
- 1
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0300-2025 | Class I | SinuCleanse Premixed SALINE PACKETS (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg) | January 28, 2025 |
| D-0301-2025 | Class I | SinuCleanse Soft Tip NETI POT Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride U | January 28, 2025 |
| D-0299-2025 | Class I | SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chlo | January 28, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K183662 | Saline Wound Wash, SteriCleanse(TM) | September 12, 2019 |