Fresenius AquaA hemodialysis water purification device pressure control malfunction
Fresenius is recalling 4 hemodialysis water purification devices for pressure control malfunctions. When concentrate pressure exceeds the 19.9 bar limit, the device stops supplying water and halts dialysis 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: This is an FDA Class II recall of a medical device with a functional malfunction that interrupts critical dialysis treatment. No injuries or hospitalizations are reported in the source text, so per the severity rubric the score is High (3) rather than Severe (4).
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 4 AquaA 900H hemodialysis water purification systems (Fresenius Part Number 24-090A-1, Vivonic Part Number G02020110, Serial Numbers 2AAV0003, 2AAV0029, 2AAV0037, and 3AAV0087). The systems are intended to purify water for use in hemodialysis treatment. These units were distributed nationwide in Alabama, Indiana, Alaska, and Wisconsin.
The recalled devices have a pressure control malfunction in the concentrate flow system. The concentrate flow pressure is exceeding the maximum safe set point of 19.9 bar, above the standard default range of 4 to 18 bar. When pressure exceeds the limit, the device triggers error message F020104 ("concentrate pressure alarm limit exceeded") and stops supplying dialysis water.
Facilities and clinics using any of the affected devices should immediately discontinue use of the recalled serial numbers and contact Fresenius Medical Care for replacement or further guidance. The FDA classified this as a Class II recall.
The recalled product
- Product
- US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers: G02020110 Fresenius Part Number: 24-090A-1
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- high-pressure-malfunction
- treatment-interruption
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)
- UDI-DI: 04251285200357 Serial Numbers: 2AAV0003 2AAV0029 2AAV0037 3AAV0087
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- 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
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03