Fresenius Optiflux F160NR Dialyzers Recalled for Potential Blood Leaks
Fresenius Medical Care is recalling Optiflux F160NR dialyzers due to a potential for external blood leaks from the dialyzer header.
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 recall involves a medical device with a potential for blood leaks, which poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Fresenius Medical Care Renal Therapies Group, LLC is recalling 9,097 cases of Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E. The recall involves specific lot numbers: 18HU06016, 18HU06017, 18HU06018, and 18HU06019.
The recall was initiated because of a potential for external blood leaks from the dialyzer header. The affected products were distributed nationwide in the United States.
Healthcare facilities and consumers should stop using the affected dialyzers and contact the recalling firm for further instructions or a replacement.
The recalled product
- Product
- Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E
- Hazard
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 (3)
- Lot Numbers: 18HU06016
- 18HU06017
- 18HU06018 and 18HU06019
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Fresenius Medical Care Renal Therapies Group, LLC
See all →- HighFresenius BlueStar Hemodialysis Machines Recalled for Alarm Defects
FDA (Devices) · 2026-09-02
- HighFresenius Recalls Liberty Cycler Cassettes Due to Potential Solution Leakage
FDA (Devices) · 2019-08-14
- LowFresenius 2008T BlueStar Hemodialysis Machines Recalled for Power Logic Board Fail Message
FDA (Devices) · 2019-06-12
- LowFresenius Granuflo Dry Acid Concentrate Recalled for Foreign Substance
FDA (Devices) · 2018-12-05
- ModerateFresenius Granuflo Dry Acid Concentrate Recalled for Foreign Substance
FDA (Devices) · 2018-12-05
Same hazard · blood leak
See all →- HighFresenius 5008X HDF Hemodialysis Blood Tubing Sets recalled for potential blood leaks
FDA (Devices) · 2025-06-25
- HighDialyzer Optiflux 160NRe recalled for potential internal blood leaks from cracked polyurethane
FDA (Devices) · 2025-01-15
- HighBaxter Revaclear 400 Dialyzers Recalled for Polyurethane Displacement
FDA (Devices) · 2022-12-28
- HighBaxter Revaclear 300 Dialyzers Recalled for Polyurethane Displacement
FDA (Devices) · 2022-12-28
- HighRevaclear 400 Dialyzers Recalled for Polyurethane Displacement Risk
FDA (Devices) · 2022-12-28