Drugs & medicalClass I

ICU Medical, Inc. recalls Plum Duo Infusion System, List Number: 400020401

ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive.

Read the official notice →
Date
2025-08-13
Country
United States
Brand
ICU Medical
Product
Plum Duo Infusion System, List Number: 400020401
Classification
Class I
Units
US Nationwide.
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More ICU Medical recalls

  1. 2025-11-05
  2. US
    Drugs & medicalClass II

    ICU Medical, Inc. recalls ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5

    Port weld of drug transfer device may separate or break during use and potentially result in a leak.

    FDA · DeviceICU Medical, Inc.Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO…Official notice →
  3. 2025-10-29
  4. US
    Drugs & medicalClass I

    ICU Medical, Inc. recalls IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm) 150 ml Burette Set…

    IV Gravity burette administration set burette component is missing an internal shutoff valve intended to stop fluid flow, which if used may result in delay in therapy during setup, over delivery/unrestricted flow, or…

    FDA · DeviceICU Medical, Inc.Worldwide distribution: US (nationwide) to states of: TX, SC and OUS (foreign)…Official notice →
  5. 2025-09-10
  6. US
    Drugs & medicalClass II

    ICU Medical Inc. recalls Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product Code 21-7001-24

    Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.

    FDA · DeviceICU Medical Inc.Worldwide distribution.Official notice →
  7. 2025-07-23
  8. US
    Drugs & medicalClass II

    ICU Medical, Inc. recalls SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-2000

    Due to a manufacturing issue, disinfecting cap for needle-free connectors may have an incomplete seal between the foil lid and plastic container, which may result in isopropyl alcohol evaporation from the sponge, which…

    FDA · DeviceICU Medical, Inc.Worldwide - US Nationwide distribution including in the states of TX, SD, ID,…Official notice →
  9. 2025-06-25
  10. US
    Drugs & medicalClass II

    ICU Medical, Inc. recalls ICU Medical Plum Solos, Item number 400011001; infusion pump

    Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the LifeShield Drug Library Manager…

    FDA · DeviceICU Medical, Inc.Worldwide - US Nationwide distribution in the states of FL, KY, VA, MS, MA,…Official notice →
  11. 2025-05-21
  12. US
    Drugs & medicalClass II

    ICU Medical, Inc. recalls LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2

    Firm has identified Drug Library Management defects in the software: 1) DLM software does not allow user to create percentage dose rate or rate change values with certain limits, potentially resulting in over-delivery…

    FDA · DeviceICU Medical, Inc.Worldwide - US Nationwide distribution in the states of CA, FL, IA, KY, LA,…Official notice →
All 29 ICU Medical recalls →

Other drugs & medical recalls in the United States

  1. 2025-08-13
  2. US
    Drugs & medicalClass I

    Flexicare Medical (Dongguan) Ltd. recalls BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref: 040-02-0110U (Mac 1), 040-02-0120U (Mac 2), 040-02-0130U (Mac…

    Laryngoscope handles may not illuminate as intended.

    FDA · DeviceFlexicare Medical (Dongguan) Ltd.US Nationwide distribution in the states of WA, SD, TX, VA, PA, OK, GA, MI,…Official notice →
  3. US
    Drugs & medicalClass I

    CareFusion 303, Inc. recalls 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;…

    Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion…

    FDA · DeviceCareFusion 303, Inc.US Nationwide Distribution to states of: AK AL AR AS AZ CA CO CT DC DE FL GA…Official notice →
  4. US
    Drugs & medicalClass I

    B BRAUN MEDICAL INC recalls Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing.

    Label is incorrect. The product label indicates that the device contains an air eliminating filter. However, the filter utilized on this extension set is not indicated for removal of air and does not feature an air…

    FDA · DeviceB BRAUN MEDICAL INCUS distribution to AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, MA, MD, ME, MI, MN,…Official notice →
  5. US
    Drugs & medicalClass II

    SUN PHARMACEUTICAL INDUSTRIES INC recalls Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St,…

    Presence of foreign substance: identified as aluminum.

    FDA · DrugSUN PHARMACEUTICAL INDUSTRIES INCUSA NationwideOfficial notice →
  6. US
    Drugs & medicalClass II

    Cardinal Health Inc. recalls RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01

    CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.

    FDA · DrugCardinal Health Inc.Nationwide Within the U.S.Official notice →
  7. US
    Drugs & medicalClass II

    Direct Rx recalls Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc.,…

    CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

    FDA · DrugDirect RxNationwideOfficial notice →
See all drugs & medical recalls →