Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Fresenius Service Replacement 0-Ring. Used in as a service part Recalled by Fresenius Medical Care Holdings, Inc. Due to Incorrect rubber nitrile O-rings distributed instead of the...
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 Fresenius Medical Care Holdings, Inc. directly.
Affected Products
Fresenius Service Replacement 0-Ring. Used in as a service part in 4 sub-assemblies manufactured and/or refurbished Fresenius hemodialysis machines, models 2008K, 2008K2, 2008K@Home and 2008T
Quantity: 725 units
Why Was This Recalled?
Incorrect rubber nitrile O-rings distributed instead of the correct material EPDM. (Ethylene Propylene Dine Monomer (M-class) rubber)
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Fresenius Medical Care Holdings, Inc.
Fresenius Medical Care Holdings, Inc. has 161 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report