FDA (Device enforcement)

11,102 recalls · page 85 of 112

• Ingenia Elition X (Product Number 781358) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system2022-01-06
• Ingenia Ambition X (Product Number 781356) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system2022-01-06
• BD Veritor Plus Analyzer - intended to provide rapid test results in near-patient settings. Catalog Number: 2560662022-01-05
• The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypo-tube and distal body coil delivery pusher with a radiopaque distal positioning marker and proximal fluorosafe marker. The Optima Coil delivery pusher2022-01-04
• eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3, eCareManager version 4.5.1, eCareManager version 4.5.2, eCareManager version 4.6.0- a software tool intended for use by trained medical staff providing supplemental remote support to bedside care teams in the managem2022-01-03
• RayStation/RayPlan- designed for treatment planning and analysis of radiation therapy. Software Version: 6.0.0.24 , 6.1.0.26 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.61 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 , 9.1.0.933 , 9.2.0.483 . Including Service Paks: Product name (build2021-12-30
• Baxter Spectrum IQ Infusion Pumps, Product code 3570009.2021-12-29
• Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product code 35700BAX2.2021-12-29
• MEDLINE Micro-Kill Bleach Germicidal Bleach Wipes2021-12-29
• da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-112021-12-23
• Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo is intended for pediatric through adult patients weighing at 2021-12-22
• SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. used with endotracheal tube (ETT)2021-12-22
• Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument available for use in the TN-ADVANCED" Tibial Nailing System (TNA), TFN-ADVANCED" Proximal Femoral Nailing System (TFNA), RFN-ADVANCED" Retrograde Femoral Nailing System (RFNA), FRN-ADVANCED" Femoral Rec2021-12-22
• Destino Twist 14F (also branded as Guidestar 14F)2021-12-22
• NIM TRIVANTAGE EMG Endotracheal Tube2021-12-22
• Dreamtome RX Cannulating Sphincterotome-DREAMTOME 44-20MM/260CM Material Number: M005840402021-12-22
• Dreamtome Cannulating Sphincterotome-DREAMTOME 44-20MM/450CM Material Number: M005840602021-12-22
• DREAMTOME 44-30MM/260CM Material Number: M005840502021-12-22
• DREAMTOME 44-30MM/450CM Material Number: M005840702021-12-22
• DREAMTOME 49-20MM/260CM Material Number: M005840002021-12-22
• DREAMTOME 49-20MM/450CM Material Number: M005840202021-12-22
• DREAMTOME 49-30MM/260CM Material Number: M005840102021-12-22
• DREAMTOME 49-30MM/450CM Material Number: M005840302021-12-22
• HYDRATOME RX 44-20MM/260CM Material Number: M005830402021-12-22
• HYDRATOME RX 44-20MM/450CM Material Number: M005830602021-12-22
• HYDRATOME RX 44-30MM/260CM Material Number: M005830502021-12-22
• HYDRATOME RX 44-30MM/450CM Material Number: M005830702021-12-22
• HYDRATOME RX 49-20MM/260CM Material Number: M005830002021-12-22
• HYDRATOME RX 49-30MM/260CM Material Number: M005830102021-12-22
• JAGTOME REVOLUTION RX 39-20-260-025 Material Number: M005842402021-12-22
• JAGTOME REVOLUTION RX 39-20-450-025 Material Number: M005842502021-12-22
• JAGTOME REVOLUTION RX 39-30-260-025 Material Number: M005842602021-12-22
• JAGTOME RX 39-20-260-025 Material Number: M005730802021-12-22
• JAGTOME RX 39-20-450-025 Material Number: M005730902021-12-22
• JAGTOME RX 39-30-260-025 Material Number: M005731002021-12-22
• JAGTOME RX 39-30-260-025 Material Number: M005731002021-12-22
• JAGTOME RX 39-30-450-025 Material Number: M005731102021-12-22
• JAGTOME RX 44-20-260-035 Material Number: M005730402021-12-22
• JAGTOME RX 44-20-450-035 Material Number: M005730502021-12-22
• JAGTOME RX 44-30-260-035 Material Number: M005730602021-12-22
• JAGTOME RX 44-30-450-035 Material Number: M005730702021-12-22
• JAGTOME RX 49-20-260-035 Material Number: M005730002021-12-22
• JAGTOME RX 49-30-260-035 Material Number: M005730202021-12-22
• JAGTOME RX 49-30-450-035 Material Number: M005730302021-12-22
• RX CHOLANGIOGRAM KIT Material Numbers: M00575241 M00575281 M00575321 M00575361 M00575381 M00575401 M00575441 M005754812021-12-22
• RX CHOLANGIOGRAM KIT - SINGLE Material Number: M00575240 M00575240 M00575280 M00575320 M00575360 M00575380 M00575400 M00575440 M005754802021-12-22
• Endurant, Endurant II and Endurant IIs Stent Graft System: Medtronic Endurant Stent Graft System Model/REF ENBF2313C120EE; ENBF2313C120EE; ENBF2313C145EE; ENBF2313C170EE; ENBF2316C120EE; ENBF2316C145EE; ENBF2316C170EE; ENBF2513C120EE; ENBF2513C145EE; ENBF2513C170EE; ENBF2516C120EE; ENBF2516C145EE; E2021-12-21
• bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventilator, 301.100.130. The bellavista 1000/1000e ventilator is intended to provide positive pressure ventilatory support to adult and pediatric patients, and optionally, infant and neonatal patients.2021-12-20
• Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm x 40 mm; Cardiovascular. Product Numbers CH08-40-75GB and CH08-40-75US2021-12-17
• NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R2021-12-17
• Draeger Fabius MRI Anesthesia Machine, Catalog Number 86073002021-12-16
• CURAD REUSABLE GEL HOT/COLD PACK2021-12-15
• Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFURB, Product Number EC300RF; c) MASTER CONSOLE EC300 LEGEND EHS, Product Number EC3002021-12-15
• OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. OXY-1 System consists of Console, Pump Drive, E Drive, and Pole Mount. The disposable Pump Lung Unit PLU part number 001-0400-100 is sold separately and is not part of this recall.2021-12-14
• OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories2021-12-13
• DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDSLM452021-12-13
• RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair of dura matter. REF: DUMO101252021-12-13
• VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box.2021-12-10
• Vaporizer Sevoflurane Maquet Filling, Part No. 6886601 Component of the following systems: Product Code(s) UPN/UDI: Flow-c Anesthesia System 6887700 07325710009765 Flow-e Anesthesia System 6887900 07325710010457 Flow-i Anesthesia System C20 6888520 07325710010617 Flow-i Anesthesia System C30 68885302021-12-09
• Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001.2021-12-08
• GLOBAL UNITE STD STEM SZ 6 Part Number: 110006102021-12-07
• GLOBAL UNITE STD STEM SZ 8 Part Number: 1100081002021-12-07
• GLOBAL UNITE REV STEM SZ 8 Part Number: 1100086002021-12-07
• GLOBAL UNITE STD STEM SZ 10 Part Number: 1100101002021-12-07
• GLOBAL UNITE REV STEM SZ 10 Product Code: 1100106002021-12-07
• GLOBAL UNITE STD STEM SZ 12 Product Code: 1100121002021-12-07
• GLOBAL UNITE STD STEM SZ 14 Product Code: 1100141002021-12-07
• GLOBAL UNITE STD STEM SZ 16 Product Code: 1100161002021-12-07
• Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT., Multi-vessel, 6F (2.2 mm) Recommended sheath, 0.014" (0.36 mm) Compatible guidewire. The HawkOne directional atherectomy system is intended for use in atherectomy of the peripheral vasculature. The HawkOne catheter2021-12-06
• Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1-S-INT, Small Vessel, 6F (2.2 mm) Recommended sheath, 0.014" (0.36 mm) Compatible guidewire. The HawkOne directional atherectomy system is intended for use in atherectomy of the peripheral vasculature. The HawkOne catheter 2021-12-06
• Alinity m System, Part No. 08N53-0022021-12-06
• LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF18372021-12-06
• ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing and presentation of medical images on display monitors for medical diagnostics Product number: ADFR and ADJC2021-12-03
• Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 303-20 PereniaDURA Lead (2.0 mm electrode inner diameter) and Model 303-30 PereniaDURA Lead (3.0 mm electrode inner diameter)2021-12-02
• Zenition 50, Model #7180962021-12-02
• Zenition 70, Model #7181332021-12-02
• Veradius Unity, Model #7181322021-12-02
• Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M0020208518902021-12-01
• Atellica CH ¿2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the quantitative determination of ¿2-microglobulin in human serum and plasma Siemens Material Number (SMN): 110976352021-12-01
• Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage, and transport in preparation for sterilization of re-usable instruments required for implanting the Triathlon Globalization Implant System for individual patients receiving primary total knee arthroplasty (TKA). Catalog# 2021-11-24
• RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics Guide/Treatment Delivery User Manual/Treatment Planning User Manual: "RefleXion X1 Model: RXM1000"2021-11-24
• Philips Allura Xper, UNIQ(Allura Xper system-China) Interventional Fluoroscopic X-ray System products with a Laird chiller WITHOUT an extended drip tray: Model Number: 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025, 72202021-11-24
• 1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. Sensis Vibe Combo, material # 11007642; UDI: 04056869010205 The Sensis recording system is a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrop2021-11-23
• VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack2021-11-22
• QIAcube Connect MDx, Model No. 90030702021-11-21
• Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. Model Number: 722005, 722006, 722008, 722010, 722012, 722013, 722025, 722026, 722022021-11-19
• Simplexa Direct Amplification Disc Kit, Product Kit Code MOL14552021-11-19
• Ki Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU The Little Wave Tyke is a manually operated device that can be used for medical purposes and is used to assist a disabled person to move from one place to another while sitting. Intended to be used by persons up to 95 pounds 2021-11-19
• SOMATOM Confidence -Computed tomography systems Model 105901002021-11-19
• SOMATOM Definition AS-Computed tomography system Model 80980272021-11-19
• SOMATOM Edge Plus-Computed tomography system Model 10267002021-11-19
• SOMATOM Definition Edge -Computed tomography system Model 105900002021-11-19
• Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 110670002021-11-18
• Senior Living Arial Emergency and Nurse Call Systems2021-11-17
• Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM2021-11-16
• cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 073419201902021-11-16
• Cardiosave Hybrid IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-UC-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-UC-0800-34, 0998-00-0800-35, 0998-UC-0800-35, 0998-00-0800-36, 0998-UC-0800-36, 0998-00-0800-45, 0998-UC-0800-45, 0992021-11-15
• Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83, 0998-UC-0800-83, 0998-00-0800-85, 0998-UC-0800-85.2021-11-15
• BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 7180752021-11-12
• BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 7180952021-11-12