Fresenius Hemodialysis Machine O-Rings Recalled for Incorrect Material
Fresenius Medical Care is recalling 725 replacement O-rings for hemodialysis machines because they were made of nitrile rubber instead of the required EPDM material.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the rubric specifies that FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). While no specific injuries are reported in the text, the use of incorrect material in a life-sustaining medical device constitutes a significant risk.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 725 units of Service Replacement O-Rings (Part Number 640919). These parts are used as service components in four sub-assemblies of Fresenius hemodialysis machines, specifically models 2008K, 2008K2, 2008K@Home, and 2008T.
The recall was initiated because the distributed O-rings were made of incorrect rubber nitrile material instead of the correct Ethylene Propylene Dine Monomer (M-class) rubber (EPDM). The FDA has classified this as a Class II recall.
The affected units were distributed nationwide, including in the states of Arkansas, California, Florida, Georgia, Kentucky, Louisiana, Massachusetts, Maryland, North Carolina, New Jersey, New York, Pennsylvania, Puerto Rico, South Carolina, Texas, and Virginia. Users of these hemodialysis machines should contact Fresenius Medical Care for instructions on how to replace the affected parts.
The recalled product
- Product
- 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
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Affected units
- 725
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 (1)
- Part Number: 640919
Distribution
Related recalls
Same manufacturer · Fresenius Medical Care Holdings, Inc.
See all →- Moderate5008X Blood Tubing Set connection errors FDA Class II recall
FDA (Devices) · 2026-07-15
- HighBicarby dialysate bags carry an incorrect GTIN on the label
FDA (Devices) · 2026-06-17
- HighBicarby dialysate luer-lock connections may leak fluid onto floors
FDA (Devices) · 2026-06-17
- SevereDELFLEX Peritoneal Dialysis Solution Recall Due to Potential Sterility Issues
FDA (Drugs) · 2026-05-13
- HighDELFLEX Peritoneal Dialysis Solution bags recalled for sterility risk
FDA (Drugs) · 2026-05-13
Same hazard · material defect
See all →- LowParagon 28 Recalls Custom Foot Implant Due to Material Defect
FDA (Devices) · 2026-08-26
- ModerateParagon 28 Recalls Custom Foot Implant Due to Material Defect
FDA (Devices) · 2026-08-26
- HighNexxZr dental zirconia discs may have reduced or missing dentin layer
FDA (Devices) · 2026-06-17
- HighMAC two-lumen central venous kits recalled over incorrectly manufactured adhesive
FDA (Devices) · 2026-04-29
- HighArrowg+ard Blue Plus four-lumen CVC kits recalled over adhesive manufacturing
FDA (Devices) · 2026-04-29