AquaBplus and AquaBplus B2 Water Purification System — Class II medical device recall Z-0098-2021

Terminated recall by Fresenius Medical Care Holdings, Inc., reported 2020-10-21, distributed in DE, NC, OK, PA, TX. Incorrectly crimped connectors were installed on the main protective earth conductor on these machines. If the

Recall number	`Z-0098-2021`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Fresenius Medical Care Holdings, Inc., Waltham, MA, United States
Recall initiated	2020-09-01
Classified	2020-10-13
Reported by FDA	2020-10-21
Terminated	2021-01-20
Distributed	DE, NC, OK, PA, TX
Quantity	15 units
Model numbers	`24-1500-1`, `24-2000-0`

Product

AquaBplus and AquaBplus B2 Water Purification System. For use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from the water used for hemodialysis or related therapies. AquaBplus 1500 - Typ USA - 3 x 208V / 60Hz -Fresenius Part Number: 24-1500-1 AquaBplus B2 2000 / B1 2500 (Bplus DUO 2000) - 3 x 208V / 60Hz- Fresenius Part Number: 24-2000-0

Reason for recall

Incorrectly crimped connectors were installed on the main protective earth conductor on these machines. If the machine is moved or maintenance is performed, these crimp connections could become loose and may adversely affect the electrical safety of the products, potentially resulting in electrical shock to the Biomed Technician or clinic staff.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0098-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.