Model Number SM-40HF-B-D-C — Class II medical device recall Z-0265-2026
Ongoing recall by SEDECAL SA, reported 2025-10-29, distributed in CA, IL, NJ. Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must
| Recall number | Z-0265-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SEDECAL SA, Algete, Spain |
| Recall initiated | 2025-06-10 |
| Classified | 2025-10-23 |
| Reported by FDA | 2025-10-29 |
| Distributed | CA, IL, NJ |
| Quantity | 5 units |
| UPC / GTIN / UDI-DI | 08436046001510 |
| Serial numbers | G-32753, G33111, G33721, G35462, G35480 |
| Model numbers | SM-40HF-B-D-C |
Product
Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system
Reason for recall
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
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-0265-2026. 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.