BEUDAMED
    159 results · 15ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Open, Classified ×

    Baxter Spectrum IQ Infusion Pumps, Product code 3570009.

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code FRN·December 29, 2021

    Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming (SPP) feature in a clinical treatment environment. Used for infusion of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions, and other therapeutic fluids.

    FDA Recall
    Open, Classified ·Smiths Medical ASD Inc.·Product code FRN·October 10, 2022

    CareFusion Alaris Syringe Module, Model 8110

    FDA Recall
    Open, Classified ·CareFusion 303, Inc.·Product code FRN·February 4, 2020

    Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.

    FDA Recall
    Open, Classified ·Fresenius Kabi USA, LLC·Product code FRN·November 21, 2025

    Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)

    FDA Recall
    Open, Classified ·EITAN MEDICAL LTD 29, Yad Kharutsim Netanya Israel·Product code FRN·September 11, 2023

    Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

    FDA Recall
    Open, Classified ·Smiths Medical ASD Inc.·Product code FRN·December 19, 2023

    Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps

    FDA Recall
    Open, Classified ·Zyno Medical LLC·Product code FRN·June 4, 2024

    ICU Medical Plum Solos, Item number 400011001; infusion pump

    FDA Recall
    Open, Classified ·ICU Medical, Inc.·Product code FRN·April 22, 2025

    LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25.

    FDA Recall
    Open, Classified ·Fresenius Kabi USA, LLC·Product code FRN·June 24, 2025

    smiths medical Medfusion Model 4000 syringe pump

    FDA Recall
    Open, Classified ·Smiths Medical ASD Inc.·Product code FRN·December 19, 2023

    Brand Name: Perfusor Space Product Name: Perfusor Space Infusion Pump System Model/Catalog Number: 8713030U Product Description: Perfusor Space Infusion Pump System, Infusion Pump, 1 each Component: N/A

    FDA Recall
    Open, Classified ·B Braun Medical Inc·Product code FRN·June 14, 2024

    Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2. Designed to be used in general operation in hospital or alternate care environments to provide warmed blood and fluids to any patients e10 kg requiring warmed infusion. Part Number:903-00006

    FDA Recall
    Open, Classified ·Belmont Instrument LLC·Product code FRN·January 2, 2025

    Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.

    FDA Recall
    Open, Classified ·Fresenius Kabi USA, LLC·Product code FRN·January 10, 2025

    Replacement Battery List Number SUB0000594 found in Plum A+ & Plum A+3 Infusion Systems, List Numbers: a) 11005, b) 11971, c) 12391, d) 12618, e) 20678, f) 20679, g) 20792, h) 60629, i) 12348, j) 11973

    FDA Recall
    Open, Classified ·ICU Medical Inc·Product code FRN·March 22, 2023

    Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with either of the following: 35700BAX2 (Spectrum V8 infusion pump) or 3570009 (Spectrum IQ infusion pump) Baxter SIGMA Spectrum V8 Infusion Pump

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code FRN·July 17, 2024

    Brand Name: Perfusor Space Product Name: PERFUSOR SPACE ACM-KIT Model/Catalog Number: 8713040U Product Description: Perfusor Space, Infusion Pump Kit, 1 each Component: N/A

    FDA Recall
    Open, Classified ·B Braun Medical Inc·Product code FRN·June 14, 2024

    Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory Infusion System); Catalog Number IT1025. Ambulatory Infusion Pump and components

    FDA Recall
    Open, Classified ·InfuTronix LLC·Product code FRN·February 21, 2024

    CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE, 1/EA, Model Number: 21-2127-0105-01; 2) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, PHARMGUARD ENABLED, 1/EA, Model Number: 21-2120-0105-01; 3) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH 1/EA, Model Number: 21-2120-0103-01; 4) PUMP, CADD-SOLIS VIP, MDL 2120, ENGLISH 1/EA, Model Number: 21-2120-0102-51; 5) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, PHARMGUARD ENABLED 1/EA, Model Number: 21-2120-0104-01; 6) PUMP KIT, CADD-SOLIS VIP, MDL 2120, CE GLOBAL ENGLISH 1/EA, Model Number: 21-2120-0103-51; 7) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE 1/EA, Model Number: 21-2127-0104-01; 8) PUMP KIT, CADD-SOLIS VIP, MDL 2120, TRIAL/LOANER, NA ENGLISH, PHARMGUARD, 1/EA, Model Number: 21-2120-0105-00; 9) PUMP, CADD-SOLIS VIP, MDL 2120, TRIAL/LOANER CE GLOBAL ENGLISH 1/EA, Model Number: 21-2120-0103-78; 10) PUMP, CADD-SOLIS VIP, MDL 2120, ENGLISH, TRIAL/LOANER 1/EA, Model Number: 21-2120-0102-78; 11) PUMP, CADD-SOLIS VIP, MDL 2120, NFHU, NA ENGLISH, PHARMGUARD ENABLED 1/EA, Model Number: 21-2120-0104-231; 12) PUMP, CADD-SOLIS VIP, MDL 2120, ENGLISH, NFHU 1/EA, Model Number: 21-2120-0102-249; 13) PUMP, CADD-SOLIS VIP, MDL 2120, NFHU CE GLOBAL ENGLISH 1/EA, Model Number: 21-2120-0103-249; 14) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, FACTORY LIBRARY 1/EA, Model Number: 21-2125-0104-01; 15) PUMP, CADD-SOLIS VIP, MDL 2120, ENGLISH, NFHU 1/EA, Model Number: 21-2120-0102-249.

    FDA Recall
    Open, Classified ·Smiths Medical ASD, Inc.·Product code FRN·April 10, 2025

    Plum Duo Infusion System, List Number: 400020401

    FDA Recall
    Open, Classified ·ICU Medical, Inc.·Product code FRN·July 11, 2025

    Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.

    FDA Recall
    Open, Classified ·Zyno Medical LLC·Product code FRN·May 7, 2025