Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
DBB-06 Hemodialysis Delivery System Recalled by Nikkiso Ltd - Shizuoka Plant Due to Device lacks premarket approval.
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Nikkiso Ltd - Shizuoka Plant directly.
Affected Products
DBB-06 Hemodialysis Delivery System
Quantity: 781 units
Why Was This Recalled?
Device lacks premarket approval.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Nikkiso Ltd - Shizuoka Plant
Nikkiso Ltd - Shizuoka Plant has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report