Lower riskMedical device recall · FDA · Published August 3, 2021
Fresenius AquaBplus Water Purification System Recall: Installation Error Risk
Fresenius Medical Care recalls AquaBplus 2000/2500 water purifiers due to installation error risk. The US installation guide incorrectly allowed 3-ring mains instead of 2-ring, potentially reducing disinfection effectiveness.
AquaBplus HF module on the AquaBplus 2000 osmosis system, an error in the US Installation Guideline instructed that 3-ring mains, instead of 2-ring mains, may be installed in combination with an AquaBplus 2000 device. The 3-ring main and fluid fly loops the heat disinfection may not be as effective as a 2-ring main installation
Take action
Contact the company
📍Recalling firmFresenius Medical Care Holdings, Inc.920 Winter St Bld 950 · Waltham, MA 02451-1521
“Fresenius AquaBplus Water Purification System Recall: Installation Error Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62089-fresenius-aquabplus-water-purification-system-recall-installation-error-risk. Based on FDA recall #Z-1364-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1364-2022%22&limit=1).
The FDA announced on August 3, 2021, that Fresenius Medical Care Holdings, Inc. voluntarily recalled AquaBplus Water Purification Systems due to a potential heat disinfection error in the installation guidelines. The agency issued recall number Z-1364-2022 for the Class II device.
How to tell if you have it
AquaBplus Water Purification System, Part Number 24-2000-0
UPC 04251285200227
UPC 04251285200289
The hazard
An error in the US Installation Guideline for the AquaBplus HF module instructed that 3-ring mains may be installed with the AquaBplus 2000 device instead of 2-ring mains. This configuration may result in heat disinfection not being as effective as intended with a proper 2-ring main installation.
Context
GovInfoNow's records show Fresenius Medical Care Holdings, Inc. has had 44 other recalls on record since April 14, 2014. Recent similar product recalls 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). Other recent recalls of similar products include the Fresenius Medical Care CombiSet Hemodialysis Tubing Set Recall (July 29, 2026), the Fresenius Medical Care 2008T BlueStar Hemodialysis Machine Recall (June 30, 2026), and the Fresenius Medical Care 5008X Blood Tubing Set Recall (August 10, 2026).
How to tell if you have this one
Check for the product names: AquaBplus 2000 or AquaBplus 2500. Look for the serial numbers listed: 7BPS1621, 7BDS0783, 7BFS0517, 7BPS1611, 7BDS0776, 7BFS0502. The US installation guide may have been used incorrectly.
Brand
Fresenius Medical Care
Product
AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - Typ USA (G02040108-US), AquaBplus 2000
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Installation Guide
Verify if your system was installed using 3-ring mains instead of 2-ring mains as per the US installation guide.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 2 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of NC and WV.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: North Carolina, West Virginia.
Recall timeline
FDA terminated this recall 2.7 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-1364-2022 (August 3, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1364-2022 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.