Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
REVACLEAR 300 Dialyzer Recalled by Baxter Healthcare Corporation Due to There is a potential presence of ruptured dialyzer...
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 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.
Quantity: 1249272 units
Why Was This Recalled?
There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.
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