Recall Register

VANTIVE US HEALTHCARE LLC: FDA recalls

FDA enforcement reports name VANTIVE US HEALTHCARE LLC as the recalling firm in 3 events. The events have 12 product records. The recalls started from 2025 to 2026. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

3 events, newest first.

FDA enforcement events of VANTIVE US HEALTHCARE LLC
InitiatedProduct (first record)TypeClassRecordsStatus
6 Jan 2026PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate SystemDeviceClass II8Ongoing
28 Aug 2025Sharesource Connectivity Platform for Use with Homechoice Claria Product Code 5CGM01 software versions 7.13.3 (China), 8.13.2 (APAC and Korea), and 8.13.4 (US, EMEA, and LATAM)DeviceClass II1Ongoing
28 Jul 2025PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701DeviceClass II3Ongoing

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

VANTIVE US HEALTHCARE LLC: events for each product type
TypeEvents
Device3
VANTIVE US HEALTHCARE LLC: events in each class
ClassEvents
Class II3
Share of the events of the firm in Class I
0%
Share of all events on the register in Class I
18%
Events with the status Ongoing
3

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of VANTIVE US HEALTHCARE LLC, by the year that the recall started. The largest year is 2025, with 2 events.

Official channels

Cite this page

Recall Register. VANTIVE US HEALTHCARE LLC: FDA recalls. https://recallregister.com/firm/vantive-us-healthcare-llc/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
IL

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of VANTIVE US HEALTHCARE LLC have?
Class II: 3 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of VANTIVE US HEALTHCARE LLC?
FDA event 98180, which the firm started on 6 Jan 2026. The first product in the record is: PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
How many FDA recalls of VANTIVE US HEALTHCARE LLC have the status Ongoing?
3 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.