[pending] Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only
Pending LLM rewrite. Source: FDA_DEVICE Z-0912-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Screw may loosen or fallout of Hemodialysis system
The recalled product
- Product
- Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only
- Manufacturer
- Nipro Medical Corporation
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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