The Recall Desk

Hazard

Bloodstream Infection 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
0
Severe
2
Most recent
2026-08-05

Of the 20 bloodstream infection recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (10%) 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 bloodstream infection 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-2804-2026·2026-08-05

    Midline Catheter Recalled Over Risk of Leaking or Cracking at Hub

    Argon Medical Devices is recalling its L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm (REF 384620) because the hub may leak or crack, potentially causing therapy interruption, blood loss, or bloodstream infection.

    Product
    L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm, REF: 384620
    Category
    Medical Device
    Distribution
    28 states
  • SevereFDA (Devices)·Z-0592-2024·2024-01-10

    Tracheostomy care kits recalled for sterility assurance failure

    Busse Hospital Disposables is recalling tracheostomy care kits containing Nurse Assist Sterile Normal Saline because the required sterility assurance level cannot be guaranteed. Contaminated products could cause serious infections including bloodstream, respiratory, and urinary tract infections, or sepsis.

    Product
    Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0593-2024·2024-01-10

    Dressing change tray recalled for sterility assurance failure

    Busse Hospital Disposables recalls sterile dressing change trays due to inability to guarantee required sterility assurance level. The defect could lead to serious infections including blood stream, urinary tract, or respiratory infections.

    Product
    Catalog No. 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0132-2024·2023-11-15

    IV Injection Set Recall: Risk of Leakage and Bloodstream Infection

    B. Braun Medical is recalling 12,800 units of TERUMO IV injection sets (Lot 0061753485) due to a manufacturing defect that may cause leakage, delaying therapy and increasing risk of bloodstream infection.

    Product
    TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070. Singapore only. IV injection set.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0133-2024·2023-11-15

    Medical administration set for radiation therapy recalled due to leakage risk

    B. Braun Medical recalls THERASPHERE ADMIN SET due to manufacturing defects causing potential leakage. Leakage may delay therapy, increase bloodstream infection risk, and expose patients and healthcare workers to hazardous medication.

    Product
    THERASPHERE ADMIN SET, Article No. 7M2650. Canada only. Sterile, single use administration set used to deliver Yttrium-90 glass microspheres for internal radiation therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0131-2024·2023-11-15

    Burette Assembly Recalled for Manufacturing Defect Causing Potential Leakage

    B. Braun recalls 30 ML 2PORT burette assemblies (lot 0061766049) for potential leakage due to manufacturing defect. Leakage risks delayed therapy, bloodstream infection, and medication exposure to patients and healthcare workers.

    Product
    30 ML 2PORT BURETTE ASSEMBLY, Article No. 7A3950, used in a contrast management system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0129-2024·2023-11-15

    SA3000 intravenous adapters recalled for manufacturing defect causing leakage

    B. Braun is recalling SA3000 intravenous adapters due to a manufacturing defect that may cause leakage. This could delay therapy, increase bloodstream infection risk, and expose patients and workers to hazardous medication.

    Product
    SA3000 VENTED MICRO SPIKE ADAPTER, REF No. 418121, for intravenous use.
    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-2546-2021·2021-10-06

    Outlook Pump IV Sets Recalled for Leakage and Infection Risk

    B. Braun Medical, Inc. is recalling approximately 44,866 Outlook Pump IV sets due to leakage of the pump set that could delay medication administration and increase the risk of bloodstream infections. The defect may result in under-delivery or incomplete medication dosing.

    Product
    Outlook¿ Pump 15 Drop 0.2 Micron Filtered IV Set with 2 CARESITE¿ Y-Sites: single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354214
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2558-2021·2021-10-06

    Outlook Pump Add-On Set Recalled for Potential Leakage and Under-Delivery

    B. Braun Medical is recalling the Outlook Pump Add-On Set due to potential leakage that may delay medication delivery and cause incomplete dosing. The affected units could increase the risk of bloodstream infections.

    Product
    Outlook Pump Add-On Set-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: V7400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2551-2021·2021-10-06

    Outlook V1500HP Pump Set Recalled for Cassette Leakage

    The Outlook V1500HP Pump Set is recalled due to cassette leakage that could delay medication delivery, reduce dosing accuracy, and cause bloodstream infections. The recall involves 12,000 units distributed in the US and Canada.

    Product
    V1500HP OUTLOOK PUMP SET 118-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 470025
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2555-2021·2021-10-06

    B. Braun Pump Set Cassette Leakage Risks Medication Delivery

    B. Braun Medical recalls 13,320 pump sets due to cassette leakage that may delay medication administration and cause incomplete dosing or bloodstream infections.

    Product
    PUMP SET, 15 DR, 3 CARESITE, 127 in.single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 480239
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2549-2021·2021-10-06

    Outlook Pump Measured Volume Solution Set recalled for cassette leakage

    B. Braun is recalling 940 units of Outlook Pump Measured Volume Solution Sets due to potential leakage in the cassette. The leakage could delay medication delivery, result in incomplete dosing, or lead to bloodstream infections.

    Product
    Outlook Pump Measured Volume Solution Set/ w/ Auto Shut-Off. Single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 375118
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2544-2021·2021-10-06

    B. Braun Infusion Pump Sets Recalled for Leakage and Infection Risk

    B. Braun Medical's infusion pump sets may leak, potentially delaying medication delivery and causing incomplete dosing. The defect poses a risk of bloodstream infections.

    Product
    15 drops/ml, Priming Volume: 27ml, Length: 129 in. Single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluid Material ID: 354212
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2559-2021·2021-10-06

    Outlook Pump Primary Administration Set Recalled for Potential Leakage and Medication Underdosing

    B. Braun Medical is recalling the Outlook Pump Primary Administration Set due to potential leakage that could delay medication delivery and cause incomplete dosing of critical fluids in epidural administration.

    Product
    Outlook Pump Primary Administration Set w/ micro Tubing for Epidural Administration-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: V7453
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2547-2021·2021-10-06

    B. Braun Infusion Pump Sets Recalled Due to Cassette Leakage Risk

    B. Braun Medical is recalling 1,960 infusion pump sets used with Outlook Safety and Horizon NXT systems due to leakage in the cassette portion, which may delay medication delivery and increase bloodstream infection risk.

    Product
    60 drops/ml, Priming volume: 25 ml, Length: 120 in.in-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354215
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2548-2021·2021-10-06

    Infusion Pump Sets Recalled for Leakage and Medication Under-Delivery Risk

    B. Braun Medical is recalling infusion pump sets that may leak, potentially causing delayed medication delivery, incomplete dosing, and bloodstream infections.

    Product
    10 drops/ml, Priming volume: 46ml, Length: 130 in.-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354216
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2556-2021·2021-10-06

    Outlook Pump Set Infusion System Recalled for Leakage and Medication Delivery Risk

    B. Braun is recalling 7,248 units of Outlook Pump Set that may leak or fail to deliver medications properly, potentially causing bloodstream infections.

    Product
    OUTLOOK PUMP SET, 3 CARESITE LADS, 115 IN-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 490361
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2550-2021·2021-10-06

    Outlook pump extension sets recalled due to leakage and dosing errors

    Outlook infusion pump extension sets may leak, potentially delaying medication delivery and causing bloodstream infections.

    Product
    ET82HP OUTLOOK PUMP EXTENSION SET-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 470024
    Category
    Medical Device
    Distribution
    Distributed nationwide