Dialysis water-treatment unit recalled for missing ferrite cores in cables
Fresenius is recalling 6 units of the AquaC UNO H reverse osmosis unit used with hemodialysis systems due to missing ferrite cores in internal ethernet cables affecting electromagnetic compatibility.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II precautionary recall with no reported illnesses or injuries; electromagnetic compatibility non-compliance in a medical device where the actual risk to patient safety is theoretical and unconfirmed.
Plain-English summary
Fresenius Medical Care is recalling 6 units of the AquaC UNO H reverse osmosis unit (Fresenius Part Number 24-0970-1) intended for use with hemodialysis systems. The internal ethernet cables in these units are missing one or both ferrite cores, which prevents the device from meeting electromagnetic compatibility standards.
Electromagnetic compatibility standards ensure medical devices function correctly without interference from or to other equipment. No illnesses or injuries have been reported in connection with this recall.
The affected units were distributed nationwide to healthcare facilities in Arizona, California, the District of Columbia, Florida, Georgia, Indiana, Massachusetts, Nevada, New York, Pennsylvania, and Texas. Healthcare facilities that have an affected unit should contact Fresenius Medical Care for replacement or remediation instructions.
The recalled product
- Product
- AquaC UNO H [120V, 60Hz, 1700VA, US-Version- a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number: 24-0970-1 Vivonic Part Number: G02000966-US
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- electromagnetic-incompatibility
- ferrite-core-defect
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03