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Use caution Medical device recall · FDA · Published March 18, 2021

Fresenius AquaBplus Water Purification System Recall: Installation Error Risk

Recall of AquaBplus and AquaBplus B2 water purification systems for hemodialysis due to installation error risk. Affected units have serial numbers starting with 5BPS, 6BPS, 7BPS, 8BPS, or 9BPS.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1536-2021Medical deviceFresenius ›
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Contact the company

Recalling firmFresenius Medical Care Holdings, Inc.920 Winter St Bld 950 · Waltham, MA 02451-1521
✎ GovInfoNow plain-language explainer

Fresenius is recalling AquaBplus and AquaBplus B2 water purification systems used with hemodialysis machines. The recall is due to an installation error in the US guidelines that could reduce the effectiveness of the heat disinfection process, potentially leading to inadequate water purification. Read more at govinfonow.com/recall/63037-fresenius-aquabplus-water-purification-system-recall-installation-error-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/63037-fresenius-aquabplus-water-purification-system-recall-installation-error-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1536-2021

Cite this page

“Fresenius AquaBplus Water Purification System Recall: Installation Error Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63037-fresenius-aquabplus-water-purification-system-recall-installation-error-risk. Based on FDA recall #Z-1536-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1536-2021%22&limit=1).

The FDA announced on March 18, 2021, that Fresenius Medical Care Holdings, Inc. is recalling AquaBplus and AquaBplus B2 Water Purification Systems due to a potential heat disinfection error. The hazard stems from an installation guideline mistake regarding mains used with the AquaBplus 2500 osmosis system.

How to tell if you have it

  • Brand: Fresenius
  • Products: AquaBplus and AquaBplus B2 Water Purification Systems
  • Fresenius P/N: 24-2500-0
  • AquaBplus 3000 - Typ USA (G02040109-US)
  • AquaBplus 2500 - Typ USA (G02040115-US)
  • AquaBplus HF- Typ USA (G02040120FMC-US)
  • First stage serial numbers: 5BPS0601, 6BPS0933, 7BPS1457, 7BPS1526, 7BPS1458, 7BPS1527, 8BPS1801, 8BPS1800, 8BPS1870, 8BPS1883, 8BPS1898, 8BPS1885, 8BPS1884, 8BPS1918, 7BPS14443, 8BPS1930, 8BPS1928, 8BPS1929, 8BPS1937, 8BPS1927, 8BPS2052, 8BPS2081, 8BPS2108, 8BPS2157, 9BPS2234, 7BPS1441, 9BPS2512
  • Second stage (B2) serial numbers: 5BDS0194, 6BDS067, 7BDS0692, 7BDS0726, 7BDS0643, 7BDS0722, 8BDS0907, 8BDS0909, 8BDS0958, 8BDS0960, 8BDS0964, 8BDS0963, 8BDS0965, 8BDS0978, 7BDS0684, 8BDS0989, 8BDS0997, 8BDS0995, 8BDS0998, 8BDS0992, 8BDS1075, 8BDS1087, 8BDS1102, 8BDS1139, 9BDS1181, 7BDS0683, 9BDS1373
  • HF option serial numbers: 5BFS0125, 6BFS0241, 7BFS0413, 7BFS0456, 7BFS0446, 7BFS0486, 8BFS0541, 8BFS0609, 8BFS0644, 8BFS0665, 8BFS0663, 8BFS0577, 8BFS0621, 8BFS0616, 7BFS0439, 8BFS0686, 8BFS0702, 8BFS0703, 8BFS0695, 8BFS0676, 8BFS0727, 8BFS0757, 8BFS0776, 8BFS0805, 9BFS0845, 7BFS0477, 9BFS0997
  • Distribution: US Nationwide in FL, MA, MD, MI, MO, NC, NJ, NY, PA, PR, SC, TN, TX

The hazard

An error in the US Installation Guideline instructed that 3-ring mains may be installed with an AquaBplus 2500 device instead of 2-ring mains. The FDA stated that heat disinfection using a 3-ring main and fluid fly loops may not be as effective as a 2-ring main installation.

Context

GovInfoNow's records show Fresenius Medical Care Holdings, Inc. has 44 other recalls on record since April 14, 2014. Other recent recalls of similar products include Fresenius Bicarby Dialysate Leaks Risk (May 12, 2026), Fresenius 5008X Blood Tubing Set Recall (May 11, 2026), and Fresenius Medical Care Bicarby Dialysate Recall (May 7, 2026). Additional recent recalls include Fresenius Medical Care 2008T BlueStar Hemodialysis Machine Recall (June 30, 2026), Fresenius Medical Care CombiSet Hemodialysis Tubing Set Recall (July 29, 2026), and Fresenius Medical Care 5008X HD/HDF with CLiC Blood Tubing Set Recall (August 10, 2026).

How to tell if you have this one

Check for serial numbers starting with 5BPS, 6BPS, 7BPS, 8BPS, or 9BPS in the first stage (AquaBplus) or second stage (B2) of the system. The product is used with hemodialysis machines to purify water for treatments.

  • Brand
    Fresenius
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Serial Numbers

    Look for serial numbers starting with 5BPS, 6BPS, 7BPS, 8BPS, or 9BPS in the first stage (AquaBplus) or second stage (B2) of the system.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 12 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFLPuerto Rico: named in the noticePR

FDA distribution: “US Nationwide distribution in the states of FL, MA, MD, MI, MO, NC, NJ, NY, PA, PR, SC, TN, TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Florida, Maryland, Massachusetts, Michigan, Missouri, New Jersey, New York, North Carolina, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas.

Recall timeline

FDA terminated this recall 3.1 years after the firm started it.

1. Firm started the recall: Mar 18, 202112. FDA classified it Class II: May 7, 202123. Published in FDA’s Enforcement Report: May 19, 202134. FDA terminated the recall: Apr 10, 2024420212024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

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-1536-2021 (March 18, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1536-2021 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA