Revaclear 400 Dialyzers Recalled for Potential Internal Blood Leaks
Baxter Healthcare Corporation is recalling 3.6 million Revaclear 400 Dialyzers due to a manufacturing defect where a twisted gasket could cause internal blood leaks during hemodialysis treatment.
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: FDA Class II recall for a medical device defect with potential for serious harm (internal blood leaks). No illnesses or injuries are reported in the source text, making this a theoretical risk rather than demonstrated harm, which qualifies as a High-severity recall per the rubric.
Plain-English summary
Baxter Healthcare Corporation is recalling 3,610,944 units of Revaclear 400 Dialyzers (Product Code: 114746L) due to a manufacturing defect. The dialyzers are used to treat patients with chronic and acute renal failure through hemodialysis.
The recall was initiated because a twisted gasket in the dialyzer could result in internal blood leaks during treatment. This manufacturing defect creates a potential safety hazard for patients undergoing dialysis.
Affected units were distributed worldwide, including throughout the United States (including Guam and U.S. Virgin Islands), Canada, and over 30 other countries across Europe, Asia, Africa, the Middle East, and the Caribbean. The FDA has identified specific affected lot numbers for this product.
Patients and healthcare providers using Revaclear 400 Dialyzers should verify whether they have affected units and consult with their dialysis center and healthcare provider for guidance on this recall. More information is available from the FDA and Baxter Healthcare Corporation.
The recalled product
- Product
- Revaclear 400 Dialyzer. Product Code: 114746L. Used to treat chronic and acute renal failure by hemodialysis.
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- blood-leak
- gasket-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI-DI: 07332414124076
- Product Code: 114746L
- Lot Numbers: C421222601
- C421222701
- C421222801
- C421222901
- C421223001
- C421223101
- C421223201
- C421223301
- C421223401
- C421223501
- C421223601
- C421223701
- C421223801
- C421223901
- C421224001
- C421224101
- C421224201
- C421224301
Distribution
Distributed nationwide across the United States.
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