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.

101–106 of 106

  • HighFDA (Devices)·Z-0660-2026·2025-12-03

    IV set 490343 recalled over piggyback backflow and priming occlusion

    B. Braun Medical is recalling 1,272 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 CARESITE…
    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…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0707-2026·2025-12-03

    Outlook set 354213 recalled over backflow into the primary container

    B. Braun Medical is recalling 18,072 units outlook sets 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 15DROP W/3 CARESITE…
    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…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0662-2026·2025-12-03

    IV set 490367 recalled over medication backflow and priming failure

    B. Braun Medical is recalling 6,768 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/60 DR/ML…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0378-2026·2025-11-05

    Infusion pumps recalled over phantom touches on the touchscreen corner

    Fresenius Kabi is recalling six Ivenix Infusion System large volume pumps over a potential issue causing the device to register phantom touches in the lower-left corner of the touchscreen.

    Product
    Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
    Category
    Medical Device
    Distribution
    Distributed nationwide