Use cautionMedical device recall · FDA · Published May 16, 2024
Fresenius US AquaA 900H-Typ USA-3 Water Purifier Recall: Concentrate Pressure Alarm Error
Fresenius recalls US AquaA 900H-Typ USA-3 hemodialysis water purifiers due to concentrate pressure exceeding safe limits, causing dialysis interruptions. Affected units have specific serial numbers and part numbers.
Concentrate Flow was exceeding the maximum 19.9 bar set point. The standard default set point range is between 4 and 18.Error message (F 02 01 04, "concentrate pressure alarm limit exceeded") concentrate pressure is too high and stops the dialysis water supply.
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Contact the company
📍Recalling firmFresenius Medical Care Holdings, Inc.920 Winter St Bld 920 · Waltham, MA 02451-1521
✎ GovInfoNow plain-language explainer
Fresenius is recalling US AquaA 900H-Typ USA-3 hemodialysis water purifiers because they can cause dialysis interruptions due to high concentrate pressure. This affects patients needing regular hemodialysis treatments who use the device. Read more at govinfonow.com/recall/55069-fresenius-us-aquaa-900h-typ-usa-3-water-purifier-recall.
“Fresenius US AquaA 900H-Typ USA-3 Water Purifier Recall: Concentrate Pressure Alarm Error.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/55069-fresenius-us-aquaa-900h-typ-usa-3-water-purifier-recall. Based on FDA recall #Z-2141-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2141-2024%22&limit=1).
The FDA announced on May 16, 2024, that Fresenius Medical Care Holdings, Inc. is recalling US AquaA 900H-Typ USA-3 water purification units due to concentrate flow exceeding safe limits. The agency issued recall number Z-2141-2024 for the Class II voluntary recall.
How to tell if you have it
Brand: Fresenius
Product: US AquaA 900H-Typ USA-3 x 208v
Intended use: Purification of water to be used for hemodialysis
Vivonic Part Numbers: G02020110
Fresenius Part Number: 24-090A-1
UDI-DI: 04251285200357
Serial Numbers: 2AAV0003, 2AAV0029, 2AAV0037, 3AAV0087
Quantity: 4 units
Distribution: Nationwide in AL, IN, AK, WI
The hazard
According to the FDA, the concentrate flow was exceeding the maximum 19.9 bar set point, triggering an error message indicating the concentrate pressure is too high and stopping the dialysis water supply. The standard default set point range is between 4 and 18.
Context
GovInfoNow's records show Fresenius Medical Care Holdings, Inc. has had 44 other recalls on record since April 14, 2014. Other recent recalls of similar products include the Fresenius Bicarby Dialysate Recall (May 12, 2026), the Fresenius 5008X Blood Tubing Set Recall (May 11, 2026), and the Fresenius Medical Care Bicarby Dialysate Recall (May 7, 2026). Additional similar product recalls include the Fresenius Medical Care 2008T BlueStar Hemodialysis Machine Recall (June 30, 2026), the Fresenius Medical Care CombiSet Hemodialysis Tubing Set Recall (July 29, 2026), and the Fresenius NaturaLyte Liquid Acid Concentrate Recall (July 14, 2026).
How to tell if you have this one
Check for serial numbers starting with 2AAV or 3AAV on the device. Affected units have Vivonic part number G02020110 and Fresenius part number 24-090A-1.
Reach out to Fresenius Medical Care for specific guidance on your unit.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 4 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of AL, IN, AK, WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Indiana, Wisconsin.
Recall timeline
FDA published this recall 34 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2141-2024 (May 16, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2141-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.