BEUDAMED
    48 results · 33ms · 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

    FreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the FreeStyle Libre 2 Flash Glucose Monitoring System

    FDA Recall
    Open, Classified ·Abbott Diabetes Care, Inc.·Product code QLG·February 13, 2023

    FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System

    FDA Recall
    Open, Classified ·Abbott Diabetes Care, Inc.·Product code QLG·July 12, 2023

    Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, 360030-1CT, 360030-1C, 360030-XC, 360030-XCT, 360030-1CTS, 360030-XCTS, 3600301-CTS, 360030-XCE, 360030-1CT, 360030-1CE, 36030-XCT

    FDA Recall
    Open, Classified ·Penner Patient Care, Inc.·Product code ILJ·August 13, 2025

    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

    FreeStyle Libre Reader, REF: 71936-01, 71937-01, 71938-01 a component of the FreeStyle Libre 14 Day Flash Glucose Monitoring System

    FDA Recall
    Open, Classified ·Abbott Diabetes Care, Inc.·Product code PZE·February 13, 2023

    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

    FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.

    FDA Recall
    Open, Classified ·Abbott Diabetes Care, Inc.·Product code QLG·November 24, 2025

    Penner Pacific Bathing Spa, Model Numbers 360010-2WT, 360010-1, 370000-1W, 360010-1WT, 362010-1, 370000-1WL, 360010-1L, 360010-1W, 360010-XWTL, 370000-XWL, 360010-1WTL, 360010-XWT, 360010-2, 370000-2W, 360010-2L, 370000-2WL, 360010-X, 370000-XW, 360010-2W, 362010-2, 360010, 37000-XWL, 362010-X, 362010-XL, 362010-1L, 360010-XL, 37000-1W, 360010-XW, 3700000-1W, 362010-2L, 36010-XWT, 370000-1L, 360010-2WT, 360000-1, 360010-XWSB, 360010-XLSB

    FDA Recall
    Open, Classified ·Penner Patient Care, Inc.·Product code ILJ·August 13, 2025

    Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the Medrad Avanta Injection System; Catalog number: AVA 500 MPAT (Part 2 of 2); Affected material numbers: 87629007, 60729458, 86566648;

    FDA Recall
    Open, Classified ·Bayer Medical Care, Inc.·Product code DXT·April 24, 2026

    FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring System

    FDA Recall
    Open, Classified ·Abbott Diabetes Care, Inc.·Product code QLG·July 24, 2024

    Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers: 06908152001, 06908217001, 06908268001, 06908349001, 06908373001

    FDA Recall
    Open, Classified ·Roche Diabetes Care, Inc.·Product code LZG·July 28, 2021

    Tandem Mobi Insulin Pump with Interoperable Technology

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

    Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control. Product REF Number: 08453071001

    FDA Recall
    Open, Classified ·Roche Diabetes Care, Inc.·Product code NBW·May 13, 2024

    t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim x2 insulin pump with the Control-IQ Technology

    FDA Recall
    Open, Classified ·Tandem Diabetes Care Inc·Product code PQF·May 24, 2022

    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

    Penner Pacific Bathing Spa, Model Numbers 860010-1L

    FDA Recall
    Open, Classified ·Penner Patient Care, Inc.·Product code ILJ·August 13, 2025

    Penner Pacific Bathing Spa, Model Numbers 361910-1A, 361910-1A, 361910-XA, 361910-2I, 361910-1A, 361910-1, 361910-XI, 361910-1I, 361910-2A, 36191-1A, 361910-X

    FDA Recall
    Open, Classified ·Penner Patient Care, Inc.·Product code ILJ·August 13, 2025

    Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X

    FDA Recall
    Open, Classified ·Penner Patient Care, Inc.·Product code ILJ·August 13, 2025