CLASS II Device recall · Reported 19 May 2021 · FDA Enforcement Report

AquaBplus and AquaBplus B2 Water Purification System recalled

Fresenius Medical Care Holdings is recalling AquaBplus and AquaBplus B2 Water Purification System, distributed nationwide in the US. The recall was initiated on 18 Mar 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial 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

Quantity recalled27 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1536-2021
FDA event ID: 87659
Recalling firm: Fresenius Medical Care Holdings, Waltham, MA
Classification: Class II
Status: Terminated
Recall initiated: 18 Mar 2021
FDA classified: 7 May 2021
Reported: 19 May 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

18 Mar 2021	Recall initiated by company
7 May 2021	Classified by FDA	+50 days
19 May 2021	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

US Nationwide distribution in the states of FL, MA, MD, MI, MO, NC, NJ, NY, PA, PR, SC, TN, TX.

Nationwide Florida Massachusetts Maryland Michigan Missouri North Carolina New Jersey New York Pennsylvania Puerto Rico South Carolina Tennessee Texas

Questions about this recall

Is AquaBplus and AquaBplus B2 Water Purification System recalled?

Yes. Fresenius Medical Care Holdings recalled AquaBplus and AquaBplus B2 Water Purification System on 18 Mar 2021. The recall is Class II and its status is Terminated. Recall number Z-1536-2021.

Why was it recalled?

Which lots are affected?

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

Where was it sold?

US Nationwide distribution in the states of FL, MA, MD, MI, MO, NC, NJ, NY, PA, PR, SC, TN, TX.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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