Fresenius Medical Care recalls 172,494,732 Optiflux High Flux E-beam Dialyzers distributed nationwide in the United States. Caps on these dialyzers were changed from threaded to press-on versions, requiring users to press the caps firmly to secure them. Patients and healthcare providers should stop using these devices immediately and follow recall instructions issued by the manufacturer.
To provide further information to the user to ensure proper use of the medical device. the caps had been changed from a threaded version to a press-on version whereby the user must press the caps firmly onto the dialyzer to securely affix the cap.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Fresenius Medical Care Holdings, Inc. or your healthcare provider for instructions. Notification method: Letter
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Optiflux High Flux E-beam Dialyzers are used in hemodialysis to remove waste products from the blood. They are sold to healthcare providers and facilities for patient treatment.
The recall centers on a cap design issue. A shift from threaded to press-on caps requires firm pressing to secure. If not secured properly, there could be device integrity concerns.
This recall is not stated as part of a broader industry pattern.
The recall affects a large stock likely used in dialysis centers. The immediate impact is operational shutdown of affected devices until replacement guidance is provided.
Refer to the FDA recall page and Fresenius Medical Care’s recall communications for model-specific guidance.
Replacement or refund options are processed after manufacturer instructions are issued. Typical timelines range from several weeks to a couple of aix.
Keep the recall letter, model numbers, purchase documentation, and all correspondence with the manufacturer and healthcare providers.
Model numbers: 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM; 0500318E OPTIFLUX F180NRe 12/CS 1.7SA EBEAM; 0500320E OPTIFLUX F200NRe 12/CS 1.9SA EBEAM; 0500325E OPTIFLUX F250NRe 12/CS 2.5SA EBEAM. Distribution: US nationwide. Quantity: 172,494,732 units (14,374,561 cases @ 12 units per case). Recall date: 2025-08-29. Recall status: ACTIVE.
No injuries or incidents have been reported.
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet instant alerts for recalls that affect you. Free forever.
Mazda North American Operations is recalling 2024 CX-90 and 2025 CX-70 SUVs sold through Mazda dealers. The PCM and ECM software can illuminate malfunction indicator lights and cause a loss of drive power, increasing crash risk. Owner notification letters were mailed December 19, 2024, and Mazda will reprogram the PCM and ECM at no charge.
Mazda North American Operations recalls 2025 Mazda CX-70 plug-in hybrids as software issues in the inverter may cause the malfunction indicator lights to illuminate and a loss of drive power in EV mode. Dealers will update inverter software at no cost. Letters were mailed December 19, 2024.
Mazda North American Operations recalls certain 2024-2025 CX-90 and 2025 CX-70 vehicles with a Dash ESU due to startup function failures. Software reprogramming will remedy the issue at no charge. Owner notices were mailed December 18, 2024. Contact Mazda at 1-800-222-5500 Option 6. NHTSA ID 24V814000.
Subaru recalls 2025 Forester vehicles due to potentially loose child seat anchor bolts. Dealers will inspect and tighten bolts at no charge. Owner letters are expected August 15, 2025. Contact Subaru at 1-844-373-6614. Recall number WRC-25.
Nissan recalls 2025 Pathfinder, Murano and INFINITI QX60 for front brake caliper weakness that could fail. Dealers will inspect and replace calipers as needed, free of charge. Letters sent May 9, 2025. Contact Nissan or INFINITI for remedies.
Mazda North American Operations is recalling 2025 CX-50 Hybrid and CX-50 SUVs sold through Mazda dealers. Incorrectly configured restraint-control software may cause the air bag to deploy improperly. Owner notification letters are expected to be mailed August 17, 2025.
Nissan North America is recalling certain 2025 Nissan Kicks vehicles sold through Nissan dealers nationwide. The certification label may print incorrect GVWR and GAWR values, risking overload. Some SR trims with a 19-inch wheel package may display an incorrect wheel size on the label, and owners should contact their Nissan dealer to arrange replacement labels.
Chrysler is recalling 2024-2025 Pacifica minivans after a radio installed during production could fail to display the rearview camera image. Dealers will replace the radio at no cost. Owner letters were mailed August 7, 2025. Contact Chrysler customer service at 800-853-1403 for details.