BEUDAMED
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    reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.

    FDA Recall
    Terminated ·Pear Therapeutics, Inc.·Product code PWE·June 7, 2021

    reSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.

    FDA Recall
    Terminated ·Pear Therapeutics, Inc.·Product code PWE·June 7, 2021

    DJO Surgical: Altivate Reverse, Humeral Stem, Small Shell, Size 6 x 108mm, REF: 533-06-108

    FDA Recall
    Open, Classified ·Product code KWS·August 4, 2023

    DJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm, REF: 400-03-443

    FDA Recall
    Open, Classified ·Product code LZO·August 4, 2023

    DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106

    FDA Recall
    Open, Classified ·Product code JWH·August 4, 2023

    DJO Surgical: CLP Hip, Stem, Polished Neck, Lateral Offset Implant, Size#3, REF: 426-11-030

    FDA Recall
    Open, Classified ·Product code KWA·August 4, 2023

    Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code KDI·July 22, 2021

    DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm, REF: 508-01-032; Baseplate, Glenoid HA-Coat, RSP, 6.5mm X 30mm, REF: 508-32-104; Reverse Shoulder System (RSP) Glenoid, Neutral Head W/ Retaining Screw, 36mm, REF: 508-36-101

    FDA Recall
    Open, Classified ·Product code PHX·August 4, 2023

    Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm, Product Code: AI-07154 - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.

    FDA Recall
    Open, Classified ·Arrow International Inc·Product code N/A·May 19, 2021

    Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140 (IPN050116). Urinary catheter.

    FDA Recall
    Open, Classified ·TELEFLEX LLC·Product code KOD·September 20, 2022

    Arrow Temporary Pacing Catheter/Introducer Kit 6Fr. pacing catheter 7Fr. introducer Product Code: AI-06210-IK - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.

    FDA Recall
    Open, Classified ·Arrow International Inc·Product code N/A·May 19, 2021

    Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Code: AI-05210 - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.

    FDA Recall
    Open, Classified ·Arrow International Inc·Product code N/A·May 19, 2021

    Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal. Intended for patients requiring endotracheal intubation

    FDA Recall
    Open, Classified ·TELEFLEX LLC·Product code BTR·December 8, 2022

    Arrow Temporary Pacing Catheter/Introducer Kit 5Fr. pacing catheter 6 Fr. introducer Product Code: AI-07155-IK - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.

    FDA Recall
    Open, Classified ·Arrow International Inc·Product code N/A·May 19, 2021

    VORTRAN Automatic Resuscitator, VARPlus with Extension Kit; Model PCE-5012; Qty: 10 each. Anesthesiology: This device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilatory support.

    FDA Recall
    Terminated ·Vortran Medical Technology 1, Inc·Product code BTL·April 20, 2017

    Endotracheal Tube labeled as the following: a. Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff; b. Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff; c. Flexiset Super Safety Clear Tracheal Tube, oral/nasal with Cuff and Insertion Aid; d. RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill; e. RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Murphy. Intended for patients requiring endotracheal intubation

    FDA Recall
    Open, Classified ·TELEFLEX LLC·Product code BTR·December 8, 2022

    Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.

    FDA Recall
    Terminated ·TELEFLEX MEDICAL INC·Product code QEW·January 11, 2022

    Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-45509-S6, PT-45509-T The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.

    FDA Recall
    Terminated ·TELEFLEX MEDICAL INC·Product code QEW·January 11, 2022

    Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy, Product Code: 9464-VC-006 (US) Product Code: 9464-EU-001 (sold in European Regions only) - Product Usage: intended for bone biopsy of the vertebral body and bone lesions.

    FDA Recall
    Open, Classified ·Arrow International Inc·Product code KNW·March 8, 2021

    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