Fresenius Optiflux F180NRe Dialyzers Recalled for Port Leak During Priming
Fresenius Medical Care is recalling Optiflux F180NRe dialyzers because the dialysate port may leak during priming, potentially compromising 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: The FDA classified this as a Class II recall, and the defect (port leak) poses a risk of harm to patients during dialysis, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 3,744,122 units of Optiflux F180NRe High Flux Dialyzers (Product Number: 0500318E). These single-use devices are intended for acute or chronic hemanalysis treatment. The recall covers specific lot numbers distributed nationwide in the United States and in Mexico.
The recall was initiated because the dialysate port may leak during the priming of the dialyzers. This defect could affect the integrity of the dialysis process. The FDA has classified this recall as Class II, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
Healthcare facilities and consumers who have these specific dialyzers should stop using them and contact Fresenius Medical Care for instructions on return or replacement. The affected lot numbers are listed in the official recall documentation.
The recalled product
- Product
- Optiflux F180NRe High Flux Dialyzers; Product Number: 0500318E. Single Use acute or chronic hemanalysis treatment.
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- Affected units
- 3,744,122
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Fresenius Medical Care Holdings, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 9 products in this recall →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 · leak
See all →- HighAVID Medical Recalls Halyard LAVH PACK Due to Sterilization Error
FDA (Devices) · 2026-08-26
- HighMedline Convenience Kits with Recalled Swan-Ganz Catheters
FDA (Devices) · 2026-07-08
- HighSwan-Ganz Pacing Catheter Model D200F7 Recall Due to Leak Risk
FDA (Devices) · 2026-05-27
- HighAnti-siphon smallbore extension sets recalled over port weld separation risk
FDA (Devices) · 2025-11-05
- HighPurple cap administration sets recalled over port weld separation risk
FDA (Devices) · 2025-11-05