Brand Name: Sonesta Product Name: 6210 Model/Catalog Number:… — Class II medical device recall Z-0460-2026
Ongoing recall by Sonesta Medical AB, reported 2025-11-19, distributed in NH. Video fluoroscopy table may contain inadequate weld on backrest bracket resulting in backrest dropping.
| Recall number | Z-0460-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sonesta Medical AB, Solna, Sweden |
| Recall initiated | 2025-08-22 |
| Classified | 2025-11-07 |
| Reported by FDA | 2025-11-19 |
| Distributed | NH |
| Quantity | 10 tables |
| UPC / GTIN / UDI-DI | 07350006950018 |
| Model numbers | 0120-LA120-03 |
Product
Brand Name: Sonesta Product Name: 6210 Model/Catalog Number: 0120-LA120-03 Software Version: N/A Product Description: Sonesta 6210 - Procedure table designed for full fluoroscopic imaging of the urinary tract during video Urodynamics procedures. Component: N/A
Reason for recall
Video fluoroscopy table may contain inadequate weld on backrest bracket resulting in backrest dropping.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0460-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.