Sonesta Medical Ab
FDA Regulatory Profile
Sonesta Medical Ab has 2 FDA recalls, 2 inspections, 0 510(k) clearances and 1 compliance action on record.
- Latest recall
- Z-0460-2026 · Class II · Aug 22, 2025
- Latest inspection
- Jun 7, 2023 · OAI
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 2 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 2 | Nov 9, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0460-2026 | Class II | Brand Name: Sonesta Product Name: 6210 Model/Catalog Number: 0120-LA120-03 Software Version: N/A… | Aug 22, 2025 |
| Z-1894-2017 | Class II | Sonesta S2; Article numbers: 525-S2-110V and 525¿¿S2-220V | Mar 8, 2017 |
Recent FDA Inspections
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3010496070 | Solna, Sweden | 2 | Jun 7, 2023 |