AquaBplus Water Purification System — Class II medical device recall Z-1364-2022
Terminated recall by Fresenius Medical Care Holdings, Inc., reported 2022-07-20, distributed nationwide. AquaBplus HF module on the AquaBplus 2000 osmosis system, an error in the US Installation Guideline instructed
| Recall number | Z-1364-2022 |
|---|---|
| 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 | 2021-08-03 |
| Classified | 2022-07-11 |
| Reported by FDA | 2022-07-20 |
| Terminated | 2024-04-10 |
| Distributed | Nationwide (US) |
| Quantity | 2 units |
| UPC / GTIN / UDI-DI | 04251285200227, 04251285200289 |
| Serial numbers | 7BDS0776, 7BDS0783, 7BFS0502, 7BFS0517, 7BPS1611, 7BPS1621 |
| Model numbers | 24-2000-0 |
Product
AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - Typ USA (G02040108-US), AquaBplus 2000 - Typ USA (G02040114-US), AquaBplus HF -Typ USA (G02040120FMC-US)
Reason for recall
AquaBplus HF module on the AquaBplus 2000 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 2000 device. The 3-ring main and fluid fly loops the heat disinfection may not be as effective as a 2-ring main installation
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-1364-2022. 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.