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    Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description: M3B Vital Signs Monitor is a patient monitoring device providing the patient with a continuous vital physiological monitoring of arterial blood oxygen saturation (SpO2), Pulse Rate and CO2 in a hospital, hospital type facilities environment and intra-hospital moves. Component: No

    FDA Recall
    Open, Classified ·Edan Diagnostics·Product code DQA·October 24, 2025

    Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A136 used in conjunction with Warming Blankets and Mattresses.

    FDA Recall
    Open, Classified ·Augustine Temperature Management, LLC·Product code DWJ·February 15, 2024

    Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A138 used in conjunction with Warming Blankets and Mattresses.

    FDA Recall
    Open, Classified ·Augustine Temperature Management, LLC·Product code DWJ·February 15, 2024

    ANSPACH - 4MM Fluted Ball, Extends 27MM; REF M-4B-27-G1. Cutting shaping bone including spine and cranium.

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code HBE·April 13, 2015

    Sorin Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz; b) Item #: 16-02-82, 208 v/60 Hz; c) Item #: 16-02-85, 120 v/60 Hz

    FDA Recall
    Terminated ·LivaNova USA·Product code DWC·April 20, 2018

    KaVo QUATTROcare Spray, 500 ml aerosol can; a maintenance spray for lubrication of KaVo turbines, air motors, straight and contra-angle dental handpieces. For use with the KaVo QUATTROcare maintenance unit only; Made in Germany The spray was produced under the following labels: a) KaVo QUATTROcare Spray AMERICA, Kaltenbach & Voigt GmbH, Biberach/Riss Germany, single can: item #04117630, type 2106, 6-pack: item #04117640, type 2106A b) KaVo QUATTROcare Spray CANADA, Kaltenbach & Voigt GmbH, Biberach/Riss Germany; Distributed by SciCan, 1440 Don Mills Rd, Toronto, Ontario, Canada M3B 3P9, single can: item #04117680, type 2107, 6-pack: item #04117690, type 2107A c) KaVo QUATTROcare Spray, Kaltenbach & Voigt GmbH, Postfach 1454, D-88396 Biberach/Riss Germany, single can: item #04117590, type 2108, 6-pack: item #04117720, type 2108A

    FDA Recall
    Terminated ·Kavo America Corporation·Product code EFB·November 22, 2006

    Contour VL Ureteral Stent Set 6FX22-30CM with .035 Sensor UPN: M006180156080

    FDA Recall
    Open, Classified ·Boston Scientific·Product code EZB·March 9, 2020

    Medtronic Model 37711 Restore Neurostimulator. The Restore Neurostimulator is an implanted, rechargeable neurostimulator which provides pain management therapy.

    FDA Recall
    Terminated ·Medtronic Inc, Neurological & Spinal Division·Product code GZB·November 22, 2005

    Percuflex Plus Ureteral Stent Set 7FX24CM with .035 Sensor UPN: M006175272080 (edited 1/13/2021)

    FDA Recall
    Open, Classified ·Boston Scientific·Product code EZB·March 9, 2020

    Sensor Nitinol Wire with Hydrophilic Tip .0383CM FLEX ANG/150CM UPN: M0066703101 box 5 UPN: M0066703100 single unit

    FDA Recall
    Open, Classified ·Boston Scientific·Product code EZB·March 9, 2020

    Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead). Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation.

    FDA Recall
    Terminated ·St. Jude Medical, Inc.·Product code GZB·July 29, 2014

    Percuflex Plus Ureteral Stent Set 6FX24CM with .038 Sensor UPN: M006175262110

    FDA Recall
    Open, Classified ·Boston Scientific·Product code EZB·March 9, 2020

    Brand Name: 3B Medical, Inc. Product Name: Ultrasoft Oxygen Cannula, 12 Foot Model / Catalog Number: O2U2012 Lot Number: 20170403 Product Description: Nasal Cannulas for use with Oxygen Concentrators

    FDA Recall
    Open, Classified ·3B Medical, Inc. 203 Avenue A Nw Ste 300 Winter Haven FL 33881-4540·Product code BZB·November 27, 2024

    Percutaneous Trial Lead Kit Model 3046 (4 ch percutaneous lead). Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation.

    FDA Recall
    Terminated ·St. Jude Medical, Inc.·Product code GZB·July 29, 2014

    Cook PTFE Wire Guide with 3 cm flexible tip, to establish a tract for ureteral/renal access, .038", 145 cm; sterile; Order/Ref number 638413.

    FDA Recall
    Terminated ·Cook Urological, Inc.·Product code EZB·June 12, 2007

    Swift-Lock (TM) Anchor Accessory Kit, Directions For Use Model 1192, ANS, A St. Jude Medical Company. Product is intended to be used as an accessory to the leads component of ANS SCS systems, functioning to secure the lead to the fascia or interspinous/supraspinous ligament.

    FDA Recall
    Terminated ·Advanced Neuromodulation Systems, Inc·Product code GZB·February 22, 2010

    Stretch VL Ureteral Stent Set 7FX22-30CM with .035 Sensor UPN: M006185157080

    FDA Recall
    Open, Classified ·Boston Scientific·Product code EZB·March 9, 2020

    Percuflex Plus Ureteral Stent Set 6FX26CM with .038 Sensor UPN: M006175263110

    FDA Recall
    Open, Classified ·Boston Scientific·Product code EZB·March 9, 2020

    Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX /150CM UPN: M0066703061 box 5 UPN: M0066703060 single unit

    FDA Recall
    Open, Classified ·Boston Scientific·Product code EZB·March 9, 2020

    Stretch VL Ureteral Stent Set 6FX22- 30CM with .035 Sensor UPN: M006185156080

    FDA Recall
    Open, Classified ·Boston Scientific·Product code EZB·March 9, 2020