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.

51–75 of 106

  • HighFDA (Devices)·Z-0678-2026·2025-12-03

    IV set 490542 recalled over backflow between primary and secondary containers

    B. Braun Medical is recalling 7,008 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 15D, 2…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0632-2026·2025-12-03

    Short extension sets recalled over piggyback backflow and occlusion

    B. Braun Medical is recalling 13,600 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. EXT SET W/ B/C VLV, ULTRAPORT, 57…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0627-2026·2025-12-03

    Extension set 473309 recalled over backflow and inability to prime

    B. Braun Medical is recalling 11,650 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. AS152V2DLL; Catalog Number…
    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…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0702-2026·2025-12-03

    IV set 354208 recalled over medication backflow and priming failure

    B. Braun Medical is recalling 126,050 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, 15DR…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0679-2026·2025-12-03

    IV set 490025 recalled over backflow into the primary container

    B. Braun Medical is recalling 15,250 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. PB1500 15 DROP IV SET W/2…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0638-2026·2025-12-03

    Caresite extension sets recalled over piggyback backflow and occlusion

    B. Braun Medical is recalling 32,500 Caresite 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. Caresite Extension Set_Export…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0578-2026·2025-12-03

    IV set 490487 recalled over piggyback backflow and occlusion risk

    B. Braun Medical is recalling 23,160 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0654-2026·2025-12-03

    IV set 354210 recalled over backflow and inability to prime

    B. Braun Medical is recalling 1,861,111 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 ANES 15DROP W/2…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0688-2026·2025-12-03

    IV set 470179 recalled over backflow into the primary bag

    B. Braun Medical is recalling 28,344 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/ B/C…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0637-2026·2025-12-03

    Extension set 456521 recalled over backflow and priming occlusion

    B. Braun Medical is recalling 61,423 units 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. ANESTHESIA SET W/ SAFEPORT…
    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…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0699-2026·2025-12-03

    IV set 490239 recalled over medication backflow between IV containers

    B. Braun Medical is recalling 5,100 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 103 IN.…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0636-2026·2025-12-03

    Extension set 490238 recalled over piggyback backflow and occlusion risk

    B. Braun Medical is recalling 11,800 units 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. EXT SET W/ 6 B/C VALVES, 17 IN…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0603-2026·2025-12-03

    Primary gravity sets recalled over backflow from secondary containers

    B. Braun Medical is recalling 43,900 ADDitIV primary gravity 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 numbers: 1. Primary Gravity IV Set, 2…
    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.…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0635-2026·2025-12-03

    Extension set 490234 recalled over piggyback backflow and occlusion risk

    B. Braun Medical is recalling 27,480 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. EXT SET ULTRAPORT STOPCOCK, 37IN.…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0675-2026·2025-12-03

    Pump IV sets recalled over backflow from piggyback into primary bags

    B. Braun Medical is recalling 65,232 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. Catalog Number: 490549…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0718-2026·2025-12-03

    IV set 490566 recalled over backflow from secondary piggyback containers

    B. Braun Medical is recalling iv administration set catalog number 490566 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, 110 IN.…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0623-2026·2025-12-03

    CARESAFE set 354302 recalled over backflow and inability to prime

    B. Braun Medical is recalling 4,438 CARESAFE sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    CARESAFE 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. CARESAFE IV ADMIN SET w/AIRSTOP, 104…
    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-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…
    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…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0642-2026·2025-12-03

    IV set 490385 recalled over medication backflow between IV containers

    B. Braun Medical is recalling 168,816 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 numbers: 1. IV ADMIN SET, 10…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0674-2026·2025-12-03

    IV set 490507 recalled over backflow and inability to prime

    B. Braun Medical is recalling 48,672 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 ADMINISTRATION SET WITH…
    Category
    Medical Device
    Distribution
    0 states