--- title: "VANTIVE US HEALTHCARE LLC Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search VANTIVE US HEALTHCARE LLC recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/vantive-us-healthcare-llc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # VANTIVE US HEALTHCARE LLC recall records **12** reported ongoing 12 records in this archive. Latest source date Jan 6, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Jan 6, 2026 FDA device enforcement ### [PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System](https://isitonrecall.com/recall/fda-device-z-1224-2026-prismaflex-st100-set-us-product-code-107636us-dialyzer-high-permeability-with-or-without-sealed-dial/) There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Seale...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1224-2026%22) Jan 6, 2026 FDA device enforcement ### [PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Without Sealed Dialysate System](https://isitonrecall.com/recall/fda-device-z-1225-2026-prismaflex-st150-set-us-product-code-107640us-dialyzer-high-permeability-with-or-without-sealed-dial/) There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Without Seale...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1225-2026%22) Jan 6, 2026 FDA device enforcement ### [OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System](https://isitonrecall.com/recall/fda-device-z-1226-2026-oxiris-set-product-code-112016-dialyzer-high-permeability-with-or-without-sealed-dialysate-system/) There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1226-2026%22) Jan 6, 2026 FDA device enforcement ### [PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System](https://isitonrecall.com/recall/fda-device-z-1227-2026-primsaflex-m100-set-product-code-106697-dialyzer-high-permeability-with-or-without-sealed-dialysate/) There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dial...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1227-2026%22) Jan 6, 2026 FDA device enforcement ### [PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System](https://isitonrecall.com/recall/fda-device-z-1228-2026-prismaflex-m150-set-product-code-109990-dialyzer-high-permeability-with-or-without-sealed-dialysate/) There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dial...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1228-2026%22) Jan 6, 2026 FDA device enforcement ### [PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System](https://isitonrecall.com/recall/fda-device-z-1229-2026-prismaflex-hf1000-set-product-code-107140-dialyzer-high-permeability-with-or-without-sealed-dialysat/) There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Di...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1229-2026%22) Jan 6, 2026 FDA device enforcement ### [PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Dialysate System](https://isitonrecall.com/recall/fda-device-z-1230-2026-prismaflex-hf1000-set-product-code-107142-dialyzer-high-permeability-with-or-without-sealed-dialysat/) There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Di...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1230-2026%22) Jan 6, 2026 FDA device enforcement ### [PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dialysate System](https://isitonrecall.com/recall/fda-device-z-1231-2026-prismaflex-tpe2000-set-product-code-114093-dialyzer-high-permeability-with-or-without-sealed-dialysa/) There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed D...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1231-2026%22) Aug 28, 2025 FDA device enforcement ### [Sharesource 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)](https://isitonrecall.com/recall/fda-device-z-0409-2026-sharesource-connectivity-platform-for-use-with-homechoice-claria-product-code-5cgm01-software-versio/) Vantive has identified a software defect within the Sharesource Claria software, which may cause a patient s updated prescription program settings to not be properly saved on the actual cycler that the patient is using to perform their therapy. As a result,... Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Hong Kong, Korea, New Zealand, Taiwan, Thailand, France, Germany, Ireland, Netherlands, Italy, Spain, Turk... [Official source for Sharesource Connectivity Platform for Use with Homechoice Claria Product Code 5CGM01 software ver...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0409-2026%22) Jul 28, 2025 FDA device enforcement ### [PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701](https://isitonrecall.com/recall/fda-device-z-2437-2025-prismax-v2-us-hemodialysis-delivery-system-product-codes-955626-955558-955627-955701/) Low deaeration chamber level at post priming tests may lead to PrisMax System alarm T2309: Air Detected in Prime resulting in multiple additional priming cycles Class II Reported ongoing Distribution: Worldwide [Official source for PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2437-2025%22) Jul 28, 2025 FDA device enforcement ### [PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724](https://isitonrecall.com/recall/fda-device-z-2438-2025-prismax-v3-control-unit-us-hemodialysis-delivery-system-product-code-955724/) Unexpected PrisMax System alarm T0830: Blood Leak Detected, when no blood leak is present, or difficulty normalizing the Blood Leak Detector (BLD) leading to PrisMax System alarms T1313: BLD Normalize Failed, T0853: Normalization Failed, or T1205: BLD Self-... Class II Reported ongoing Distribution: Worldwide [Official source for PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2438-2025%22) Jul 28, 2025 FDA device enforcement ### [TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631](https://isitonrecall.com/recall/fda-device-z-2439-2025-thermax-blood-warmer-unit-us-prismax-accessory-product-codes-955630-955515-955702-955631/) Thermax System may be unable to detect the presence of a bag on the Thermax Blood Warmer Unit leading to difficulty setting up therapy, or PrisMax System alarm T2284: Thermax Disposable Not Inserted Class II Reported ongoing Distribution: Worldwide [Official source for TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2439-2025%22) ## Reasons in these listed records - There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. - Vantive has identified a software defect within the Sharesource Claria software, which may cause a patient s updated prescription program settings to not be properly saved on the actual cycler that the patient is using to perform their therapy. As a result, the clinician may t... - Low deaeration chamber level at post priming tests may lead to PrisMax System alarm T2309: Air Detected in Prime resulting in multiple additional priming cycles - Unexpected PrisMax System alarm T0830: Blood Leak Detected, when no blood leak is present, or difficulty normalizing the Blood Leak Detector (BLD) leading to PrisMax System alarms T1313: BLD Normalize Failed, T0853: Normalization Failed, or T1205: BLD Self-Test Failure These examples come from this result page and are not a ranking of every recall reason. ## Checking VANTIVE US HEALTHCARE LLC ### Is there a recall on vantive us healthcare llc right now? This archive contains 12 records, including 12 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search VANTIVE US HEALTHCARE LLC](https://isitonrecall.com/check/?q=VANTIVE%20US%20HEALTHCARE%20LLC) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)