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-0640-2026·2025-12-03

    Universal infusion sets recalled over piggyback backflow and priming occlusion

    B. Braun Medical is recalling 49,330,370 Infusomat administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    Infusomat 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. UNIV.15DROP PUMP SET W/3 SAFELINE LL;
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0633-2026·2025-12-03

    IV set 490283 recalled over backflow between primary and secondary containers

    B. Braun Medical is recalling 65,904 units iv administration 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 number: 1. EXTENSION SET W/ B/C VALVE 53 in.;
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0610-2026·2025-12-03

    Extension set 490358 recalled over backflow into the primary container

    B. Braun Medical is recalling 1,200 units extension sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    Anesthesia IV 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, 15D, 144 IN.; Cat
    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 I
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0671-2026·2025-12-03

    Vented pump sets recalled over medication backflow and occlusion risk

    B. Braun Medical is recalling 12,168 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/ML
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0696-2026·2025-12-03

    IV set 490437 recalled over piggyback backflow and occlusion risk

    B. Braun Medical is recalling 4,536 units 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/ML
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0681-2026·2025-12-03

    IV set 490426 recalled over piggyback backflow and occlusion risk

    B. Braun Medical is recalling 63,192 units 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/10 DROPS, 13
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0687-2026·2025-12-03

    IV set 490407 recalled over medication backflow between IV containers

    B. Braun Medical is recalling 10,896 units 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/CARESITE EXT
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0677-2026·2025-12-03

    IV set 490612 recalled over medication backflow between IV containers

    B. Braun Medical is recalling 5,952 units 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. 15DR 2SAFELINE 1CARESITE 1S
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0658-2026·2025-12-03

    IV set 470005 recalled over medication backflow and priming failure

    B. Braun Medical is recalling 29,900 units 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 15DR 3 CARESITE, 124
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0650-2026·2025-12-03

    IV set 490317 recalled over backflow and occlusion risk

    B. Braun Medical is recalling 6,650 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 AD SET CARESITE 127 IN.
    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, 16
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0631-2026·2025-12-03

    Extension set 490629 recalled over backflow and priming occlusion

    B. Braun Medical is recalling 13,128 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 number: 1. EXTENSION SET, 25 IN.; Catalog Numb
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0634-2026·2025-12-03

    Extension sets recalled over piggyback backflow into primary containers

    B. Braun Medical is recalling 23,650 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 number: 1. EXTENSION SET W/ ULTRAPORT, 48 IN.;
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0625-2026·2025-12-03

    Caresite set 354202 recalled over backflow and inability to prime

    B. Braun Medical is recalling 2,871,707 units caresite sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    Caresite 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. Primary Gravity IV Set with 2 CARESITE¿
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0622-2026·2025-12-03

    Burette set 490159 recalled over backflow into the primary container

    B. Braun Medical is recalling 7,240 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 W/ 2 CARESITE, 134 IN.; C
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0717-2026·2025-12-03

    IV set 490508 recalled over backflow into the primary container

    B. Braun Medical is recalling IV administration set catalog number 490508 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/ 15DROPS/ML;
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0655-2026·2025-12-03

    IV set 457504 recalled over medication backflow and priming failure

    B. Braun Medical is recalling 80,650 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 W/2 CARESITE & 2 ULT
    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 W
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0691-2026·2025-12-03

    IV set 490408 recalled over backflow between primary and secondary containers

    B. Braun Medical is recalling 24,072 units 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, 2 CARESITES,
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0628-2026·2025-12-03

    Smallbore extension sets recalled over backflow and inability to prime

    B. Braun Medical is recalling 30,250 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 number: 1. ET08US EXTENSION SET W/ULTRA Y SITE
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0703-2026·2025-12-03

    IV set 490301 recalled over backflow from secondary piggyback containers

    B. Braun Medical is recalling 31,392 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 AD.SET W/15 DR 128 IN, E
    Category
    Medical Device
    Distribution
    0 states