The Recall Desk

Hazard

Hypovolemia recalls

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

What the numbers show

Total
10
Critical
0
Severe
4
Most recent
2026-09-09

Of the 10 hypovolemia recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (40%) 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 hypovolemia 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.

1–10 of 10

  • SevereFDA (Devices)·Z-3085-2026·2026-09-09

    Fresenius 5008X Blood Tubing Set Recalled for Potential Blood Leak

    Fresenius Medical Care is recalling 5008X HD/HDF Standard Blood Tubing Sets due to a heightened probability of blood leak from the Arterial Alpha Clip connection.

    Product
    5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3087-2026·2026-09-09

    Fresenius 5008X HD/HDF Blood Tubing Set Recalled for Leak Risk

    Fresenius Medical Care is recalling 5008X HD/HDF blood tubing sets due to a heightened probability of blood leaks that could cause blood loss and hypovolemia.

    Product
    5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3086-2026·2026-09-09

    Fresenius 5008X HD/HDF Blood Tubing Set Recalled for Leak Risk

    Fresenius Medical Care is recalling 18,600 units of 5008X HD/HDF blood tubing sets due to a heightened probability of blood leaks that could cause blood loss and hypovolemia.

    Product
    5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3084-2026·2026-09-09

    Fresenius Medical Care Recalls 5008X Standard HD Pre-Flush Blood Tubing Sets

    Fresenius Medical Care is recalling 120 units of 5008X Standard HD Pre-Flush Blood Tubing Sets due to a heightened probability of blood leaks during treatment.

    Product
    5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2810-2026·2026-08-05

    Arterial Cannula Recalled Due to Risk of Pinhole Leaks During Bypass

    Medtronic is recalling 3,621 EOPA 3D Arterial Cannula DIL TIP 22FR units because pinhole leaks may occur during cardiopulmonary bypass, risking hypovolemia, vessel injury, hypotension, ischemia, and organ dysfunction.

    Product
    EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78222
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2808-2026·2026-08-05

    Arterial Cannula Recalled Due to Pinhole Leaks During Cardiopulmonary Bypass

    Medtronic is recalling its EOPA arterial cannula because pinhole leaks may occur during bypass, risking hypovolemia, vessel injury, and organ dysfunction.

    Product
    EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77622
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2806-2026·2026-08-05

    Arterial Cannula Recall: Medtronic EOPA Blunt 22FR May Leak During Bypass

    Medtronic recalls 21,290 EOPA arterial cannulas (BLUNT 22FR) because pinhole leaks may occur during bypass, risking hypovolemia, vessel injury, hypotension, ischemia, and organ dysfunction.

    Product
    EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77422
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2811-2026·2026-08-05

    Arterial Cannula Recall: EOPA 3D 22FR May Develop Pinhole Leaks During Bypass

    Medtronic is recalling EOPA 3D Arterial Cannula 22FR because pinhole leaks may occur during cardiopulmonary bypass, potentially causing hypovolemia, vessel injury, hypotension, ischemia, and organ dysfunction.

    Product
    EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78322
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0091-2023·2022-10-26

    IV Extension Sets Recalled for Bonded Joint Failure and Leakage Risk

    B. Braun extension sets (Product Code 470169) are recalled due to high probability of bonded joint failure, which may cause leakage or detachment during use, risking bloodstream infections and medication exposure.

    Product
    Extension Set, EXT SET W/CARESITE, 6IN., Product Code 470169, 50 units per carton. A6 Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0090-2023·2022-10-26

    ULTRASITE US04TL Extension Sets recalled for bonded joint failure risk

    B. Braun is recalling ULTRASITE Extension Sets because the bonded joint has a high probability of failure during use. Device failure could cause leakage, bloodstream infections, and delays in therapy.

    Product
    ULTRASITE US04TL Smallbore T-Port Extension Set, Product Code 474515, 100 units per carton. to provide needle-free access on I.V. and Extension Sets
    Category
    Medical Device
    Distribution
    Distributed nationwide