The Recall Desk

Hazard

Infusion Set recalls

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

What the numbers show

Total
5
Critical
0
Severe
1
Most recent
2025-10-01

Of the 5 infusion set recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (20%) 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 set 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.

1–5 of 5

  • HighFDA (Devices)·Z-2594-2025·2025-10-01

    Intravenous solution sets recalled after customer reports of tubing separation

    Baxter is issuing an urgent recall for one lot of Continu-Flo Solution Sets, REF 2C8519, after customer reports of tubing separation. 14,400 units are affected.

    Product
    Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL. 112" (2.8 m), Product Code REF 2C8519; intravascular administration set
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2180-2025·2025-08-13

    BD Alaris pump infusion sets may perform outside established flow ranges

    BD Alaris Pump Infusion Sets are being recalled because the pump module used with them may perform outside the established ranges for flow rate, bolus accuracy and occlusion alarm timing.

    Product
    BD Alaris Pump Infusion Sets REF: 10013186, BD Alaris Pump Infusion Set, Back Check Valve, 3 SmartSite Y-sites LVP 60D DEHP FREE 3SS CV; REF: 2452-0007, BD Alaris Pump Infusion Set, 2 Back Check Valves, 3 SmartSite Y-sitesAS LVP 10D 3SS 2CV; REF: 2204-0007, BD Alaris Pum
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2234-2025·2025-08-06

    LVP primary administration sets have potential for external cassette leaks

    LVP Primary Administration Sets, Single Outlet Low Sorbing, are being recalled because of the potential for external cassette leaks. 35,925 units are affected.

    Product
    LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2232-2025·2025-08-06

    LVP dual-inlet administration sets have potential for external cassette leaks

    LVP Primary Administration Sets, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site, are being recalled because of the potential for external cassette leaks. 19,225 units are affected.

    Product
    LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2235-2025·2025-08-06

    LVP dual Y-site administration sets have potential for external cassette leaks

    LVP Primary Administration Sets, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site, are being recalled because of the potential for external cassette leaks. 348,150 units are affected.

    Product
    LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25.
    Category
    Medical Device
    Distribution
    Distributed nationwide