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    Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor System

    FDA Recall
    Open, Classified ·Paragon 28, Inc. 14445 Grasslands Dr Englewood CO 80112-7062·Product code MBI·July 13, 2022

    Non-continuous ventilator accessories under the following brand names: a) REMStar Plus M US model number DS200; b) REMStar Plus M w/Humid AHP model number AHP200H; c) REMStar Plus M w/Humid US model number DS200H; d) REMStar Plus M w/Humid, w/Smartcard, AHP model number AH200HS; e) REMStar Plus M w/Smartcard, US model number DS200S; and f) REMStar Plus w/C Flex Dom model number 1009586. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.

    FDA Recall
    Terminated ·Respironics, Inc.·Product code BZD·October 15, 2007

    3M Bair Hugger(M) Normothermia System, Sterile Full Access Underbody, Model 63700 The 3M Bair Hugger Temperature Management System is intended to prevent and treat hypothermia. In addition, the temperature management system can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The temperature management system can be used with adult and pediatric patients.

    FDA Recall
    Terminated ·3M Company Health Care Business 3m Center·Product code DWJ·January 23, 2018

    3M Bair Hugger(M) Normothermia System, Full Access Underbody Warming Blanket, REF 63500 The 3M Bair Hugger Temperature Management System is intended to prevent and treat hypothermia. In addition, the temperature management system can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The temperature management system can be used with adult and pediatric patients.

    FDA Recall
    Terminated ·3M Company Health Care Business 3m Center·Product code DWJ·January 23, 2018

    P28 JAWS Nitinol Staple System kits are designed for use in an osteotomy, arthrodesis and fragment fixation of bones and joints of the foot including fixation of small bone fragments.

    FDA Recall
    Terminated ·Paragon 28, Inc.·Product code JDR·December 19, 2017

    DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables and or WLAN connections. The DPM Central Station is used for remote monitor management, storing, printing, reviewing, or processing of information from net worked devices, and it is operated by medical personnel in hospitals or medical institutions.

    FDA Recall
    Terminated ·Mindray DS USA, Inc. d.b.a. Mindray North America·Product code MSX·May 12, 2011

    NAVIO Soft Tissue Protector, included in instrument kits. The NAVIO Tissue Protector is a reusable instrument designed to, when used as instructed, provide the required bone pin spacing for the Navio bone clamps and potentially reduce the amount of patient tissue affected when placing the bone pins.

    FDA Recall
    Terminated ·Smith & Nephew, Inc.·Product code OLO·February 27, 2020

    3M Red Dot Electrodes, Radiolucent Monitoring Electrode with Foam Tape, Catalog No. 2244, (3M ID (SKU): 70-2011-8506-6, SAP ID: 7100212989), packaged 10 electrodes per card, 5 cards per pouch, 20 pouches per shipper box, 1,000 electrodes total per shipper box. The 3M Red Dot Radiolucent Monitoring Electrode with Foam Tape 2244 is intended to be used by healthcare professionals for ECG monitoring. This electrode is disposable, intended for single use, and has been tested for up to 3 days wear.

    FDA Recall
    Terminated ·3M Company Health Care Business 3m Center·Product code DRX·October 6, 2021

    Blood Monitoring Unit (BMU 40), model no. 701040852 - Product Usage: is to monitor blood parameters during cardiopulmonary bypass (CPB) or similar procedures with extracorporeal circulation, which require continuous monitoring of the arterial and/or venous blood parameters: partial pressure of oxygen (pO2), temperature (TArt and TVen), oxygen saturation (SO2), hemoglobin (Hb) and hematocrit (Hct).

    FDA Recall
    Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code DRY·September 30, 2020

    3M Attest Steam Chemical Integrators, REF 1243B

    FDA Recall
    Open, Classified ·3M Company Health Care Business 3m Center·Product code JOJ·April 6, 2023

    3M Attest Steam Chemical Integrators, REF 1243A

    FDA Recall
    Open, Classified ·3M Company Health Care Business 3m Center·Product code JOJ·April 6, 2023

    Syn go Imaging XS is a picture archiving and communication system intended to display, process, read, report, communicate, distribute, store and archive digital radiological images, including digital mammography images.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code LLZ·March 10, 2008

    Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175L

    FDA Recall
    Open, Classified ·Paragon 28, Inc. 14445 Grasslands Dr Englewood CO 80112-7062·Product code HSB·December 21, 2023

    Medtronic One Source Pack Magellan, Catalog Number: COS310. Kits are packaging convenience kits containing previously released sterile-pack products and accessories. Medtronic Ideal MAXPAC Total System

    FDA Recall
    Terminated ·Medtronic Cardiovascular Revascularization & Surgical Therap·Product code OEU·March 23, 2009

    Medtronic EOPA Arterial Cannula, Model # 77620. Lot: 2015060544 intended to deliver oxygenated blood to the heart during cardiopulmonary bypass procedures for up to 6 hours in duration.

    FDA Recall
    Terminated ·Medtronic Perfusion Systems·Product code DWF·July 24, 2015

    Medtronic One Source Pack, Catalog Numbers: ATLS21, ATLS24, ATLS2469, EC1S24, EC2S00, EC2S24, EE1S048 and EE2S21. Kits are packaging convenience kits containing previously released sterile-pack products and accessories.

    FDA Recall
    Terminated ·Medtronic Cardiovascular Revascularization & Surgical Therap·Product code OEU·March 23, 2009

    Phantom TTC Nail, 10.0 X 200mm, Right

    FDA Recall
    Open, Classified ·Paragon 28, Inc. 14445 Grasslands Dr Englewood CO 80112-7062·Product code HSB·December 21, 2023

    Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R

    FDA Recall
    Open, Classified ·Paragon 28, Inc. 14445 Grasslands Dr Englewood CO 80112-7062·Product code HSB·December 21, 2023

    TOMTEC-ARENA TTA2;software version no. 2.20 and lower; Picture archiving and communications system. Software Versions and applicable UDI: TTA 1.2 release prior to UDI requirement TTA2.00.01 release prior to UDI requirement TTA2.11.01 release prior to UDI requirement TTA2.11.02 release prior to UDI requirement TTA2.20.01 UDI: (01)04260361440143(11)160429(10)20.01 TTA2.20.10 UDI:(01)04260361440143(11)160809(10)20.10 TTA2.20.13 UDI:(01)04260361440143(11)160922(10)20.13 TTA2.20.14 UDI:(01)04260361440143(11)161028(10)20.14 TTA2.20.15 UDI: (01)04260361440143[11]161207[10]20.15 TTA2.20.16 UDI:(01)04260361440143(11)170127(10)20.16 TTA2.20.18 UDI:(01)04260361440143(11)170622(10)20.18

    FDA Recall
    Open, Classified ·Tomtec Imaging Systems Gmbh Edisonstr. 6 Unterschleisheim Germany·Product code LLZ·September 23, 2019

    LFIT Anatomic CoCr Femoral Heads, 6260-9-036

    FDA Recall
    Terminated ·Howmedica Osteonics Corp.·Product code JDI·May 22, 2018