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    Quantum Intersegmental Table, Model/Catalog Number: Q400; heated massage table

    FDA Recall
    Open, Classified ·Pivotal Health Solutions, Inc.·Product code ISA·October 9, 2025

    PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device that enables treatment with piezoelectric shockwaves (Therapeutic massager).

    FDA Recall
    Open, Classified ·Richard Wolf GmbH Pforzheimer Str. 32 Knittlingen Germany·Product code ISA·April 9, 2025

    Quantum Intersegmental Table, Model/Catalog Number: AMQ400H; heated massage table

    FDA Recall
    Open, Classified ·Pivotal Health Solutions, Inc.·Product code ISA·October 9, 2025

    The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a mobile assembly of electrically-powered components intended for imaging and analysis of soft-tissue and vasculature using combined optoacoustic (photoacoustic) and ultrasound (US) imaging.

    FDA Recall
    Open, Classified ·Ithera Medical Gmbh Zielstattstr. 13 Munich Germany·Product code REK·January 8, 2025

    Firefly Floorsitter, Firefly Splashy Bathseat, Firefly GoTo Seat - Product Usage: The Splashy Bath-Seat is a Portable bath seat for children aged 1-8, The GoTo Seat is a light-weight, portable, postural support seat for kids, aged between 1 and 8 with disabilities.

    FDA Recall
    Open, Classified ·James Leckey Design Ltd 19C Ballinderry Road Lisburn United Kingdom·Product code ILS·February 18, 2020

    EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS Product Description: The EnVisio Patient Pad Transition Cushion is a component of the EnVisio Navigation System which is a medical device that detects the presence of the SmartClip Soft Tissue Marker(s) and provides real-time three-dimensional navigation during surgery.

    FDA Recall
    Open, Classified ·Elucent Medical Inc·Product code NEU·November 18, 2024

    Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).

    FDA Recall
    Open, Classified ·Abbott·Product code DQY·June 12, 2023

    Arial Call Station, Model Numbers CSK200-1069 and CSK200-1069MR, is a wireless nurse call station.

    FDA Recall
    Open, Classified ·Securitas Healthcare LLC·Product code IQA·June 20, 2024

    Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution Model/Catalog Number: 533682 Product Description: In US Celsior is a class II medical device. Celsior is a clear to slightly yellow, sterile, non pyrogenic solution for hypothermic flushing and storage of hearts. Celsior can be used for hypothermic cardiac flushing and storage in preparation for transportation and eventual transplantation of the heart into the recipient. Celsior is packaged in one liter bag with 4 units per carton box. Celsior shall be stored between 36 to 46F. In Europe Celsior is a drug and can be used for thoracic organs (heart & lung) and abdominal organs (liver, kidney, pancreas).

    FDA Recall
    Open, Classified ·INSTITUT GEORGES LOPEZ 6 ROUTE DE SAINT BONNET ST LAURENT DE CHAMOUSSET France·Product code MSB·March 13, 2025

    MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code MWI·September 6, 2022

    Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.

    FDA Recall
    Open, Classified ·Elekta Instrument AB Kungstensgatan 18 Stockholm Sweden·Product code IWB·June 27, 2018

    'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805

    FDA Recall
    Open, Classified ·New Standard Device Inc·Product code KTT·July 23, 2019

    CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system.

    FDA Recall
    Open, Classified ·Maquet Medical Systems USA·Product code DTQ·October 10, 2023

    VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a cryopreservation storage device composed of a stick and cap.

    FDA Recall
    Open, Classified ·CooperSurgical, Inc.·Product code MQK·April 1, 2022

    TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.020 TEMA Elbow System is a cemented total elbow prosthesis.

    FDA Recall
    Open, Classified ·Limacorporate S.p.A Via Nazionale 52 Di San Daniele San Daniele Del Friuli Italy·Product code JDB·October 2, 2024

    Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2000sp.)

    FDA Recall
    Open, Classified ·Abbott Molecular, Inc.·Product code OOI·February 1, 2024

    My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device

    FDA Recall
    Open, Classified ·Onkos Surgical, Inc.·Product code QHQ·May 20, 2025

    EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovascular System.

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code QEY·October 13, 2022

    Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number: VAC-6000MT Product Description: The Clinical Innovations Kiwi is a disposable vacuum assisted fetal delivery system. It is a sterile, single-patient-use device designed to provide assistance in childbirth under the following conditions: 1) Term pregnancy, 2) Ruptured amniotic membranes, 3) Engaged head, 4) Complete cervical dilation, and 5) Adequately trained or supervised operator.

    FDA Recall
    Open, Classified ·Clinical Innovations, LLC·Product code HDB·March 9, 2026

    Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory electrocardiogram.

    FDA Recall
    Open, Classified ·Spacelabs Healthcare, Ltd. Unit B Foxholes Centre; John Tate Road Hertford United Kingdom·Product code MWJ·November 25, 2024