BEUDAMED
    191 results · 23ms · Sources: EU EUDAMED, US FDA

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    t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology

    FDA Recall
    Open, Classified ·Tandem Diabetes Care, Inc.·Product code QFG·March 5, 2024

    Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient s subcutaneous tissue. As with current insulin infusion pumps on the U.S. market, the desired timing and quantity of the insulin delivery is programmed by the user (i.e., the patient). Pump, Tandem Mobi, Control-IQ/1010750, Pump, Tandem Mobi, Control-IQ, Replacement/1012719, Pump, Tandem Mobi, Control-IQ 7.6.0.3, Medicare/1013501, Pump, Tandem Mobi, Control-IQ 7.7/1013655, Pump, Tandem Mobi, Control-IQ, 7.7, Replacement/1013656, Pump, Tandem Mobi, Control-IQ 7.7, Medicare/1013700, Pharmacy Kit, Starter Pack, Tandem Mobi 7.7/1014081

    FDA Recall
    Open, Classified ·Tandem Diabetes Care, Inc.·Product code QFG·October 6, 2025

    t:slim X2 Insulin Pump with Interoperable Technology

    FDA Recall
    Open, Classified ·Tandem Diabetes Care, Inc.·Product code QFG·February 27, 2025

    t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)

    FDA Recall
    Open, Classified ·Tandem Diabetes Care, Inc.·Product code QFG·July 3, 2025

    Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current). US: PT-000599- Omnipod 5 App Software Package (provided through Google Play), EU: PT-001323- Omnipod 5 App Software Package (provided on locked-down Controllers (PT-001194 and PT-001193). Used to control an insulin pump.

    FDA Recall
    Open, Classified ·Product code QFG·November 30, 2023

    MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61

    FDA Recall
    Open, Classified ·Medtronic MiniMed, Inc.·Product code QFG·January 30, 2026

    Omnipod 5 Automated Insulin Delivery System

    FDA Recall
    Open, Classified ·Product code QFG·February 28, 2023

    Tandem Mobi Insulin Pump with Interoperable Technology

    FDA Recall
    Open, Classified ·Tandem Diabetes Care, Inc.·Product code QFG·February 27, 2025

    iLet Bionic Pancreas, REF: BB1001

    FDA Recall
    Open, Classified ·Beta Bionics, Inc.·Product code QFG·September 23, 2025

    t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, and User Guide when using Dexcom G7 sensor; Tandem Mobi insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014801, 1014811, 1014813, and User Guide when using Dexcom G7 sensor

    FDA Recall
    Open, Classified ·Tandem Diabetes Care, Inc.·Product code QFG·August 5, 2025

    MiniMed 780G Insulin Pump (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896)

    FDA Recall
    Open, Classified ·Medtronic MiniMed, Inc.·Product code QFG·February 13, 2026

    iLet Bionic Pancreas, REF: BB1001

    FDA Recall
    Open, Classified ·Beta Bionics, Inc.·Product code QFG·March 12, 2026

    Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7

    FDA Recall
    Open, Classified ·Product code QFG·March 12, 2026

    iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software

    FDA Recall
    Open, Classified ·Beta Bionics, Inc.·Product code QFG·August 13, 2025

    Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient s subcutaneous tissue. As with current insulin infusion pumps on the U.S. market, the desired timing and quantity of the insulin delivery is programmed by the user (i.e., the patient).

    FDA Recall
    Open, Classified ·Tandem Diabetes Care, Inc.·Product code QFG·January 30, 2026

    Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacement, Refurbished, REF: 1003808; t: slim X2, Basal-IQ, mg/dl, REF: 1004219; Pump, t:slim X2, Clinical Use Only, REF: 1004484; Pump, t:slim X2, Control-IQ, REF: 1005611; Pump, t:slim X2, Control-IQ, mmoUL, Refurbished Replacement, REF: 1005613; Pump, t:slim X2, Control-IQ, mg/dl, REF: 1005615; Pump, t:slim X2, Control-IQ, mg/dl, Refurbished Replacement, REF: 1005617; Pump, t:slim X2, Basal-IQ 6.4, Refurbished Replacement, REF: 1006379; Pump, t:slim X2, Control-IQ 7.4, REF: 1006402; Pump, t:slim X2, Control-IQ 7.4, Replacement, REF: 1006406; Pump, t:slim X2, Control-IQ 7.4, REF: 1006408; Pump, t:slim X2, Basal-IQ, , REF: 1006419; Pump, t:slim X2, Basal-IQ, mg/dL, REF: 1006420; Pump, t:slim X2, Basal-IQ, mmoUL, Refurbished Replacement, REF: 1006535; Pump, t:slim X2, Basal-IQ, mg/dL, Refurbished Replacement, REF: 1006537; Pump, t:slim X2, Control-IQ, mg/dl , Replacement, REF: 1008255; Pump, t:slim X2, Control-IQ, mmoUL, Replacement, REF: 1008256; Pump, t:slim X2, Basal-IQ, mmoUL, Replacement, REF: 1008257; Pump, t:slim X2, Basal-IQ, mg/dl ,Replacement, REF: 1008258; Pump, t:slim X2, Basal-IQ, REF: 1010004; Pump, t:slim X2, Basal-IQ, Replacement, REF: 1010005; Pump, t:slim X2, Basal-IQ, Medicare, REF: 1010006; Pump, t:slim X2, Basal-IQ, Medicare, REF: 1010007; Pump, t:slim X2, Control-IQ, REF: 1010009; Pump, t:slim X2, Control-IQ Replacement, REF: 1010010; Pump, t:slim X2, Control-IQ, Medicare, REF: 1010011; Pump, t:slim X2, Control-IQ, Refurbished Replacement, REF: 1010012; Pump, t:slim X2, Control-IQ, REF: 1012867; Pump, t:slim X2, Control-IQ, Medicare, REF: 1012868; Pump, t:slim X2, Control-IQ, Replacement, REF: 1012869; Pump, t:slim X2, Control-IQ 7.8, REF: 1013195; Pump, t:slim X2, Control-IQ 7.8, Medicare, REF: 1013196; Pump, t :slim X2, Control-IQ 7.8, Replacement, REF: 1013197; Pump, t:slim X2, Control-IQ 7.8, Refurbished Replacement, REF: 1013198

    FDA Recall
    Open, Classified ·Tandem Diabetes Care, Inc.·Product code QFG·July 21, 2025

    Omnipod 5 Automated Insulin Delivery System Product catalog numbers: PT-000409: ASM, Omnipod 5, PDM, Programmed PT-000428: Adaptor, Charging, Noetic Nuu N5004L, Horizon PDM, US PT-000429: Cable, Charging, Omnipod 5, Horizon PDM

    FDA Recall
    Open, Classified ·Product code QFG·November 14, 2022

    UHF Grollman Pigtail Long Tip Non-wirebraid, 7FG, 110 cm, Angiographic Catheter, Sterile, Merit Medical.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc·Product code DQO·November 5, 2003

    GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.

    FDA Recall
    Open, Classified ·GE Healthcare·Product code LLZ·August 5, 2024

    Flixene IFG with Assisted Delivery Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.

    FDA Recall
    Terminated ·Atrium Medical Corporation·Product code DSY·July 12, 2013