# FDA recall Z-0282-2026

> **SEDECAL SA** · Class II · device recall initiated 2025-06-10.

## Product

SED URS LP, 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.

## Distribution

US:  CA, IL, and NJ

## Key facts

- **Recall number:** Z-0282-2026
- **Recalling firm:** SEDECAL SA
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-06-10
- **Report date:** 2025-10-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Algete, Spain

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0282-2026

## Citation

> AI Analytics. FDA recall Z-0282-2026. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0282-2026. Source: US FDA. Licensed CC0.

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