Data Foundry

Medical device recalls 2022

AquaC UNO H [120V — Class II medical device recall Z-1464-2022

Ongoing recall by Fresenius Medical Care Holdings, Inc., reported 2022-08-03, distributed nationwide. Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised due to high

Recall numberZ-1464-2022
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmFresenius Medical Care Holdings, Inc., Waltham, MA, United States
Recall initiated2022-06-16
Classified2022-07-25
Reported by FDA2022-08-03
DistributedNationwide (US)
Quantity318 units
UPC / GTIN / UDI-DI04251285200234
Serial numbers0CHS4237, 0CHS4238, 0CHS4239, 0CHS4240, 0CHS4268, 0CHS4269, 0CHS4270, 0CHS4271, 0CHS4272, 0CHS4273, 0CHS4289, 0CHS4290, 0CHS4291, 0CHS4292, 0CHS4293, 0CHS4294, 0CHS4295, 0CHS4296, 0CHS4297, 0CHS4298, 0CHS4347, 0CHS4348, 0CHS4349, 0CHS4350, 0CHS4385 and 293 more
Model numbersG02000970-US

Product

AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US

Reason for recall

Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised due to high temperature and result in the internal ethernet cable conducting electrical current to the ethernet port on the outside of the device), potentially harming service technicians and/or other authorized operators. If the ethernet port on the device is touched or manipulated, there is a risk of electrical shock

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-1464-2022. 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.