The Recall Desk

Manufacturer

Vantive US Healthcare LLC

12 recalls in our database name Vantive US Healthcare LLC as the manufacturing or recalling firm.

What the numbers show

Total
12
Critical
0
Severe
0
Most recent
2026-02-11

Of the 12 recalls from Vantive US Healthcare LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–12 of 12

  • ModerateFDA (Devices)·Z-1225-2026·2026-02-11

    Prismaflex ST150 sets recalled over a deaeration chamber that may dislodge

    Vantive US Healthcare is recalling 264,040 units of the PRISMAFLEX ST150 SET US because the Prismaflex Set deaeration chamber may dislodge from the Prismaflex Control Unit.

    Product
    PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1224-2026·2026-02-11

    Prismaflex ST100 sets recalled over a deaeration chamber that may dislodge

    Vantive US Healthcare is recalling 87,436 units of the PRISMAFLEX ST100 SET US because the Prismaflex Set deaeration chamber may dislodge from the Prismaflex Control Unit.

    Product
    PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1231-2026·2026-02-11

    Prismaflex TPE2000 sets recalled over a deaeration chamber that may dislodge

    Vantive US Healthcare is recalling 13,760 units of the PRISMAFLEX TPE2000 SET because the Prismaflex Set deaeration chamber may dislodge from the Prismaflex Control Unit.

    Product
    PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dialysate System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1228-2026·2026-02-11

    Prismaflex M150 sets recalled over a deaeration chamber that may dislodge

    Vantive US Healthcare is recalling 137,576 units of the PRISMAFLEX M150 SET because the Prismaflex Set deaeration chamber may dislodge from the Prismaflex Control Unit.

    Product
    PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1226-2026·2026-02-11

    Oxiris sets recalled over a deaeration chamber that may dislodge

    Vantive US Healthcare is recalling 2,724 Oxiris Sets because the Prismaflex Set deaeration chamber may dislodge from the Prismaflex Control Unit.

    Product
    OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1227-2026·2026-02-11

    Prismaflex M100 sets recalled over a deaeration chamber that may dislodge

    Vantive US Healthcare is recalling 230,596 Prismaflex M100 Sets because the Prismaflex Set deaeration chamber may dislodge from the Prismaflex Control Unit.

    Product
    PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1230-2026·2026-02-11

    Prismaflex HF1000 sets recalled over a deaeration chamber that may dislodge

    Vantive US Healthcare is recalling 115,112 units of the PRISMAFLEX HF1000 SET because the Prismaflex Set deaeration chamber may dislodge from the Prismaflex Control Unit.

    Product
    PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Dialysate System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1229-2026·2026-02-11

    Prismaflex HF1000 set 107140 recalled over a dislodging deaeration chamber

    Vantive US Healthcare is recalling 93,576 Prismaflex HF1000 Sets, product code 107140, because the deaeration chamber may dislodge from the Prismaflex Control Unit.

    Product
    PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0409-2026·2025-11-05

    Dialysis connectivity software recalled because prescription changes may not reach cyclers

    Vantive is recalling the Sharesource Connectivity Platform for Homechoice Claria because a software defect may stop updated prescription settings from saving on the patient's cycler.

    Product
    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)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2438-2025·2025-09-03

    Dialysis control units recalled over false blood leak detection alarms

    PrisMax V3 Control Units are recalled because of unexpected blood leak alarms when no leak is present, or difficulty normalizing the blood leak detector. 2,449 units are affected.

    Product
    PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2439-2025·2025-09-03

    Blood warmer units recalled because system may not detect inserted bag

    TherMax Blood Warmer Units, an accessory to the PrisMax system, are recalled because the system may be unable to detect a bag on the unit, causing setup difficulty or alarm T2284. 7,432 units are affected.

    Product
    TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2437-2025·2025-09-03

    Hemodialysis delivery systems recalled over priming alarm requiring additional priming cycles

    PrisMax V2-US hemodialysis delivery systems are recalled because a low deaeration chamber level at post-priming tests may trigger alarm T2309, resulting in multiple additional priming cycles. 4,772 units are affected.

    Product
    PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701
    Category
    Medical Device
    Distribution
    0 states