The Recall Desk

Hazard

Dialysis recalls

20 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
20
Critical
1
Severe
0
Most recent
2026-06-17

Of the 20 dialysis recalls we have scored against our rubric, 1 (5%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all dialysis recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–20 of 20

  • HighFDA (Devices)·Z-2321-2026·2026-06-17

    Bicarby dialysate luer-lock connections may leak fluid onto floors

    Bicarby Dialysate across six model numbers is being recalled because luer-lock leaks during preparation present a potential slip and fall hazard from fluid on the floor.

    Product
    Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2401-2026·2026-06-17

    Bicarby dialysate bags carry an incorrect GTIN on the label

    Bicarby Dialysate, model RFP-400-G, is being recalled because of an error in the GTIN printed on the product, which could lead to a potassium concentration differing from the prescription.

    Product
    Bicarby Dialysate; Model number: RFP-400-G;
    Category
    Medical Device
    Distribution
    1 state
  • 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-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-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-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
  • 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-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
  • HighFDA (Devices)·Z-0987-2026·2025-12-31

    Dialysis concentrate 100225 recalled because safety and efficacy cannot be assured

    Diasol is recalling 186,000 containers of liquid concentrate for bicarbonate dialysis, product 100225-10-DEX100, because the safety and efficacy of the dialysis acid concentrate cannot be assured.

    Product
    Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0989-2026·2025-12-31

    Dialysis concentrate 100220 recalled because safety and efficacy cannot be assured

    Diasol is recalling 4400 gallons of liquid concentrate for bicarbonate dialysis, product 100220-10-DEX100, because the safety and efficacy of the dialysis acid concentrate cannot be assured.

    Product
    Brand Name: Diasol Product Name: 100220-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0988-2026·2025-12-31

    Dialysis concentrate 100125 recalled because safety and efficacy cannot be assured

    Diasol is recalling 7,200 gallons of liquid concentrate for bicarbonate dialysis, product 100125-10-DEX100, because the safety and efficacy of the dialysis acid concentrate cannot be assured.

    Product
    Brand Name: Diasol Product Name: 100125-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0990-2026·2025-12-31

    Dialysis concentrate 100230 recalled because safety and efficacy cannot be assured

    Diasol is recalling 4,400 gallons of liquid concentrate for bicarbonate dialysis, product 100230-10-DEX100, because the safety and efficacy of the dialysis acid concentrate cannot be assured.

    Product
    Brand Name: Diasol Product Name: 100230-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0992-2026·2025-12-31

    Dialysis concentrate 100425 recalled because safety and efficacy cannot be assured

    Diasol is recalling 2200 gallons of liquid concentrate for bicarbonate dialysis, product 100425-10-DEX100, because the safety and efficacy of the dialysis acid concentrate cannot be assured.

    Product
    Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0991-2026·2025-12-31

    Dialysis concentrate 100325 recalled because safety and efficacy cannot be assured

    Diasol is recalling 74,400 gallons of liquid concentrate for bicarbonate dialysis, product 100325-10-DEX100, because the safety and efficacy of the dialysis acid concentrate cannot be assured.

    Product
    Brand Name: Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0936-2026·2025-12-24

    Dialysis machines recalled over software anomalies that may stop treatment

    Fresenius Medical Care is recalling 115 5008X CAREsystem units over several software anomalies with the potential to impact patient treatment, one of which may result in treatment stop.

    Product
    5008X CAREsystem +CLiC +CDX;
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0912-2026·2025-12-17

    Hemodialysis systems recalled because a screw may loosen or fall out

    Nipro Medical is recalling Surdial DX Hemodialysis Systems because a screw may loosen or fall out of the system.

    Product
    Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only
    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
  • CriticalFDA (Devices)·Z-0070-2026·2025-10-29

    Hemodialysis bloodline sets recalled over micro air bubbles from damaged connectors

    B. Braun is recalling Streamline Bloodline Sets for Dialog because damaged arterial and venous patient connectors may cause micro-air bubbles in the bloodline and air-in-line alarms.

    Product
    Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalog Number: SL-2010M2096 Software Version: N/A Product Description: STREAMLINE BLOODLINE SET FOR DIALOG Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide