Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Revaclear 400 dialyzers. Indicated for treatment of chronic and acute Recalled by Baxter Healthcare Corporation Due to Reports of Polyurethane Displacement in the dialyzer, and...
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 Baxter Healthcare Corporation directly.
Affected Products
Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
Quantity: 6,338,280 units
Why Was This Recalled?
Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Baxter Healthcare Corporation
Baxter Healthcare Corporation has 401 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report