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.
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
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.
The US installation guidelines incorrectly instructed that 3-ring mains could be used with the AquaBplus 2500 device instead of 2-ring mains. This error may cause the heat disinfection process to be less effective, potentially allowing contaminants to remain in the water.
Hemodialysis patients and healthcare facilities using the AquaBplus 2500 or AquaBplus B2 systems. Those with the specific serial numbers listed in the recall are most at risk.
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.
Look for serial numbers starting with 5BPS, 6BPS, 7BPS, 8BPS, or 9BPS in the first stage (AquaBplus) or second stage (B2) of the system.
The US installation guidelines incorrectly instructed that 3-ring mains could be used with the AquaBplus 2500 device instead of 2-ring mains, which may reduce the effectiveness of the heat disinfection process.
Check the serial numbers on your AquaBplus system. If they start with 5BPS, 6BPS, 7BPS, 8BPS, or 9BPS, contact Fresenius for guidance on next steps.
The recall record does not specify a remedy or fix for this issue.
We’ve drafted a message you can send Fresenius to request your refund or repair — edit it as you like.
Subject: Recall Z-1536-2021 — Fresenius Fresenius Hello, I own a Fresenius that is covered by recall Z-1536-2021 from Fresenius. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
