AquaBplus and AquaBplus B2 Water Purification System - Product Usage: Intended for use with a hemodialysis…
Medical device recall Z-1536-2021. Published in FDA’s Enforcement Report on May 19, 2021.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on May 19, 2021. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 13 states named
- 27 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
AquaBplus HF module on the AquaBplus 2500 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 2500 device. The 3-ring main and fluid fly loops the heat disinfection may not be as effective as a 2-ring main installation
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
AquaBplus and AquaBplus B2 Water Purification System - Product Usage: Intended for use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from the water used for hemodialysis or related therapies. Fresenius P/N 24-2500-0 All 3 units make up the AquaBplus 2500Fresenius Part Number: G02040109-US AquaBplus 3000 - Typ USA G02040115-US AquaBplus 2500 - Typ USA G02040120FMC-US AquaBplus HF- Typ USA
27 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial number first stage (AquaBplus): 5BPS0601 6BPS0933 7BPS1457 7BPS1526 7BPS1458 7BPS1527 8BPS1801 8BPS1800 8BPS1870 8BPS1883 8BPS1898 8BPS1885 8BPS1884 8BPS1918 7BPS14443 8BPS1930 8BPS1928 8BPS1929 8BPS1937 8BPS1927 8BPS2052 8BPS2081…
Every code shown here, 827 characters
Serial number first stage (AquaBplus): 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. Serial number second ¿stage(B2): 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. Serial number HF option: 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
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US Nationwide distribution in the states of FL, MA, MD, MI, MO, NC, NJ, NY, PA, PR, SC, TN, TX.
The states and territories these words name
13 states and territories.
Every one of them
- Florida
- Massachusetts
- Maryland
- Michigan
- Missouri
- North Carolina
- New Jersey
- New York
- Pennsylvania
- Puerto Rico
- South Carolina
- Tennessee
- Texas
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Mar 18, 2021.
- FDA classified it on May 7, 2021.
- FDA’s Enforcement Report published it on May 19, 2021.
- FDA terminated it on Apr 10, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Fresenius Medical Care Holdings, Inc., of Waltham, MA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.