Data Foundry

Medical device recalls 2022

AquaC UNO H [120V — Class II medical device recall Z-1770-2022

Ongoing recall by Fresenius Medical Care Holdings, Inc., reported 2022-09-28, distributed nationwide. Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of t

Recall numberZ-1770-2022
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmFresenius Medical Care Holdings, Inc., Waltham, MA, United States
Recall initiated2022-06-21
Classified2022-09-19
Reported by FDA2022-09-28
DistributedNationwide (US)
Quantity6 units
UPC / GTIN / UDI-DI04251285200234
Serial numbers0CHS3987, 0CHS4108, 1CHS5372, 1CHS5405, 9CHS2881, 9CHS3090
Model numbers24-0970-1, G02000966-US

Product

AquaC UNO H [120V, 60Hz, 1700VA, US-Version- a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number: 24-0970-1 Vivonic Part Number: G02000966-US

Reason for recall

Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured

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-1770-2022. 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.