The Recall Desk

Hazard

Infusion recalls

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

What the numbers show

Total
106
Critical
2
Severe
0
Most recent
2026-01-21

Of the 106 infusion recalls we have scored against our rubric, 2 (2%) 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 infusion 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.

1–25 of 106

  • HighFDA (Devices)·Z-1094-2026·2026-01-21

    Infusion pumps recalled over speakers that may not produce audible alarms

    ICU Medical is recalling 423 Plum Duo Infusion Systems after one lot of defective primary speakers may fail to produce sound, so the pump may not produce audible alarms or alerts.

    Product
    Plum Duo Infusion System, List Number 40002-04-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0885-2026·2025-12-24

    Infusion pump software recalled over anomalies that could cause serious harm

    Fresenius Kabi USA is recalling Ivenix Infusion System LVP software versions 5.10.1 and earlier, which the firm states contain anomalies with the potential to cause serious patient harm or death.

    Product
    Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
    Category
    Medical Device
    Distribution
    20 states
  • CriticalFDA (Devices)·Z-0586-2026·2025-12-10

    Infusion pump administration sets recalled over incorrect assembly of one lot

    Fresenius Kabi USA is recalling 483 cases of Ivenix LVP Primary Administration Sets after incorrect assembly of a specific lot that the firm states could result in serious patient injury.

    Product
    IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump Administration Set.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0701-2026·2025-12-03

    IV set 490070 recalled over piggyback backflow and occlusion risk

    B. Braun Medical is recalling 9,500 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. NF1500UP, IV…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0680-2026·2025-12-03

    Gravity IV sets recalled over medication backflow and inability to prime

    B. Braun Medical is recalling 12,200 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. NF1503 15 DR UNIV SPIKE…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0621-2026·2025-12-03

    Burette sets recalled over medication backflow and inability to prime

    B. Braun Medical is recalling 12,320 burette sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    Burette Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. BURETTE SET, 4 CARESITE LADS, STPCK…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0605-2026·2025-12-03

    ADDitIV set 352062 recalled over backflow and inability to prime

    B. Braun Medical is recalling 12,700 ADDitIV sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    ADDitIV utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. PB602VSL NON-VENT SET 103-IN-DR; Catalog…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0705-2026·2025-12-03

    Small volume IV sets recalled over backflow and priming failure

    B. Braun Medical is recalling 4,488 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. AESTHESIA IV SET, 127 in.…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0689-2026·2025-12-03

    Secondary IV sets recalled over backflow into the primary container

    B. Braun Medical is recalling 25,728 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, QUAD…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0630-2026·2025-12-03

    IV extension sets recalled over backflow between piggyback and primary containers

    B. Braun Medical is recalling 43,452 extension sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog numbers: 1. EXTENSION SET, 18 IN; Catalog…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0692-2026·2025-12-03

    Large volume IV sets recalled over piggyback backflow and occlusion risk

    B. Braun Medical is recalling 45,288 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. 130 IN. IV ADMIN SET W/ 9…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0682-2026·2025-12-03

    IV set 490488 recalled over backflow between primary and secondary containers

    B. Braun Medical is recalling 187,464 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0676-2026·2025-12-03

    Vented IV sets recalled over piggyback backflow and inability to prime

    B. Braun Medical is recalling 40,992 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0698-2026·2025-12-03

    IV set 490274 recalled over backflow into the primary container

    B. Braun Medical is recalling 98,568 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 3 CARESITE…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0672-2026·2025-12-03

    IV set 490519 recalled over piggyback backflow and priming occlusion

    B. Braun Medical is recalling 1,080 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 15 DROP, 132…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0667-2026·2025-12-03

    Infusion pump sets recalled over medication backflow and occlusion

    B. Braun Medical is recalling 37,656 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0659-2026·2025-12-03

    IV set 490242 recalled over backflow into the primary bag

    B. Braun Medical is recalling 129,480 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 60 DROP/ML…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0704-2026·2025-12-03

    Infusion sets recalled over backflow from secondary bags into primary

    B. Braun Medical is recalling 122,232 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, 129 IN, 3…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0648-2026·2025-12-03

    Administration set 354209 recalled over backflow and inability to prime

    B. Braun Medical is recalling 89,552 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ANES 15DROP W/2…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0649-2026·2025-12-03

    IV set 490208 recalled over medication backflow between IV containers

    B. Braun Medical is recalling 40,008 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DR / mL…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0716-2026·2025-12-03

    Outlook set 354214 recalled over backflow and inability to prime

    B. Braun Medical is recalling Outlook set catalog number 354214 over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. OUTLOOK IV SET 15DR W/2 CARESITE…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0651-2026·2025-12-03

    Pump administration sets recalled over piggyback backflow and priming failure

    B. Braun Medical is recalling 135,000 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV SET 3 CARESITE ULTRA…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0604-2026·2025-12-03

    ADDitIV sets recalled over backflow between primary and secondary containers

    B. Braun Medical is recalling 100 ADDitIV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    ADDitIV utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. V1782F UNIV IV SET W/0.2 MICRON FILTER…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0710-2026·2025-12-03

    Rate flow sets recalled over backflow and inability to prime

    B. Braun Medical is recalling 150,664 RATE FLOW sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    RATE FLOW set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. RATEFLOW ADMIN 15 DROP W/2…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0694-2026·2025-12-03

    IV administration sets recalled over backflow from piggyback containers

    B. Braun Medical is recalling 2,544 IV administration sets over the potential for medication to flow back from secondary piggyback containers into primary containers, and an inability to prime.

    Product
    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 124 IN.…
    Category
    Medical Device
    Distribution
    0 states