The Recall Desk

Hazard

Blood Leak recalls

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

What the numbers show

Total
14
Critical
0
Severe
3
Most recent
2025-06-25

Of the 14 blood leak recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (21%) 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 blood leak 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.

1–14 of 14

  • HighFDA (Devices)·Z-1992-2025·2025-06-25

    Fresenius 5008X HDF Hemodialysis Blood Tubing Sets recalled for potential blood leaks

    Fresenius Medical Care is recalling 5008X HDF Hemodialysis Blood Tubing Sets due to potential blood leaks between the venous chamber and tubing. The recall affects hemodialysis, hemodiafiltration, hemofiltration, and isolated ultrafiltration procedures nationwide.

    Product
    5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodline, Model Number: 03-5100-7. b. 5008X Standard HDF Bloodline w/CLIC, Model Number: 03-5100-7C. c. 5008X Standard HDF Bloodline w/ Twister, Model Number: 03-5150-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0764-2023·2022-12-28

    Baxter Revaclear 400 Dialyzers Recalled for Polyurethane Displacement

    Baxter Healthcare is recalling Revaclear 400 dialyzers because polyurethane displacement may cause blood leaks during dialysis treatment. Approximately 1.14 million units are affected worldwide.

    Product
    Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0762-2023·2022-12-28

    Baxter Revaclear 300 Dialyzers Recalled for Polyurethane Displacement

    Baxter is recalling approximately 14 million units of Revaclear 300 dialyzers worldwide due to polyurethane displacement that could cause blood leaks. No injuries have been reported.

    Product
    Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0763-2023·2022-12-28

    Revaclear 400 Dialyzers Recalled for Polyurethane Displacement Risk

    Baxter Healthcare is recalling Revaclear 400 dialyzers due to reports of polyurethane displacement, which could result in blood leaks during dialysis treatment. The recall affects over 6 million units distributed worldwide.

    Product
    Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0761-2023·2022-12-28

    Revaclear 400 Dialyzer recall due to potential internal blood leaks

    Baxter Healthcare recalls Revaclear 400 Dialyzer units due to potential internal blood leaks caused by twisted gaskets. The defect may affect dialysis patients worldwide.

    Product
    Revaclear 400 Dialyzer. Product Code: 114749M. Not distributed in the USA. Used to treat chronic and acute renal failure by hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0760-2023·2022-12-28

    Revaclear 400 Dialyzers Recalled for Potential Internal Blood Leaks

    Baxter Healthcare Corporation is recalling 3.6 million Revaclear 400 Dialyzers due to a manufacturing defect where a twisted gasket could cause internal blood leaks during hemodialysis treatment.

    Product
    Revaclear 400 Dialyzer. Product Code: 114746L. Used to treat chronic and acute renal failure by hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1343-2021·2021-04-14

    Fenwal Recalls Amicus MNC Apheresis Kits Due to Centrifuge Pack Leaks

    Fenwal Inc is recalling specific lots of Amicus MNC Apheresis Kits because centrifuge packs may leak blood during therapeutic procedures.

    Product
    Amicus MNC Apheresis Kit - Double Needle - Product Usage: intended for use in the collection of blood components and mononuclear cells.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1344-2021·2021-04-14

    Fenwal Recalls Amicus Exchange Kits Due to Centrifuge Pack Leaks

    Fenwal Inc is recalling 2,466 Amicus Exchange Kits because centrifuge packs may leak blood during therapeutic procedures.

    Product
    Amicus Exchange Kit - Product Usage: intended for use in the collection of blood components and mononuclear cells.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1345-2021·2021-04-14

    Fenwal Recalls Amicus Exchange Kits Due to Centrifuge Pack Leaks

    Fenwal Inc is recalling 24 units of Amicus Exchange Kits because centrifuge packs may leak blood during therapeutic procedures.

    Product
    Amicus Exchange Kit Therapeutics - Product Usage: intended for use in the collection of blood components and mononuclear cells.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1908-2019·2019-07-10

    Baxter Recalls Revaclear 300 Dialyzers Due to Potential Fiber Rupture

    Baxter Healthcare is recalling Revaclear 300 dialyzers because ruptured fibers may cause blood leaks during hemodialysis treatment.

    Product
    REVACLEAR 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1909-2019·2019-07-10

    Baxter Recalls Revaclear 400 Dialyzers Due to Potential Fiber Rupture

    Baxter Healthcare is recalling Revaclear 400 dialyzers because ruptured fibers may cause blood leaks during hemodialysis treatment.

    Product
    REVACLEAR 400 Dialyzer, Product Code 114746L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0658-2019·2018-12-26

    Fresenius Optiflux F160NR Dialyzers Recalled for Potential Blood Leaks

    Fresenius Medical Care is recalling Optiflux F160NR dialyzers due to a potential for external blood leaks from the dialyzer header.

    Product
    Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1314-2018·2018-04-18

    Terumo Cardiovascular Procedure Kits Recalled for Potential Blood Leaks

    Terumo is recalling 2,677 Cardiovascular Procedure Kits containing Pall LG6NS filters due to a risk of blood leaks through the hydrophobic portion.

    Product
    Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filters. The Cardiovascular Procedure Kit containing the Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filter for Exh¿acorporeal Service is indicated for use o
    Category
    Medical Device
    Distribution
    7 states