The Recall Desk

Hazard

Sepsis Risk recalls

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

What the numbers show

Total
5
Critical
0
Severe
1
Most recent
2024-02-21

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

1–5 of 5

  • HighFDA (Devices)·Z-1076-2024·2024-02-21

    FDA Recalls Heart-Lung Machine Component Over Sterile Barrier Defect

    Maquet is recalling an HLS Set Advanced 5.0 component used in CARDIOHELP heart-lung machines due to a compromised sterile barrier that may cause infection. The recall affects 6,657 US units.

    Product
    Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the CARDIOHELP heart-lung machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0978-2024·2024-02-14

    RotaFlow Centrifugal Pump sterile barrier defect FDA Class II recall

    RotaFlow Centrifugal Pumps have potential seal defects that could compromise sterile barriers, risking infection in cardiac bypass patients. FDA recommends device identification and contact with manufacturer for remediation.

    Product
    BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 701047553. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0655-2024·2024-01-17

    Abiomed Introducer Kits Recalled for Sterile Barrier Pouch Defect

    Abiomed is recalling 84 introducer kits that may have holes in the outer pouch, compromising the sterile barrier. This exposes patients to microbial contamination and risk of serious infections including bacteremia and sepsis.

    Product
    Abiomed Kit, 23Fr Introducer, 11cm, Sterile Part of Pump Set (1000323)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 2000342
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0594-2024·2024-01-10

    Tracheostomy care sets recalled for sterility assurance failure

    Busse Hospital Disposables is recalling tracheostomy care kits due to failed sterility assurance. The affected product cannot guarantee required sterility levels and poses risks of infection and sepsis.

    Product
    Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1639-2023·2023-06-07

    Maquet QUADROX-i Adult Oxygenator recalled for packaging damage compromising sterile barrier

    Maquet Medical Systems is recalling QUADROX-i Adult Oxygenators due to potential packaging damage that may compromise sterile barriers, risking infection during cardiopulmonary bypass surgery.

    Product
    BEQ-HMO 71000-USA /QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067829
    Category
    Medical Device
    Distribution
    Distributed nationwide