Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 121 of 548
FDA Devices Moderate Apr 19, 2023
Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 7.5F (2.5mm), Usable Length 110 cm…
Edwards Lifesciences, LLC
FDA Devices Moderate Apr 19, 2023
CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030 and 709031
Philips North America Llc
FDA Devices Moderate Apr 19, 2023
Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis
Coloplast Manufacturing US, LLC
FDA Devices Moderate Apr 19, 2023
Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
Coloplast Manufacturing US, LLC
FDA Devices Moderate Apr 19, 2023
Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleeve and 5 - 10 mm reducer, Product Number S101010
Covidien, LP
FDA Devices Moderate Apr 19, 2023
Digital VIPR ROC-9839 Roberts Oxygen Ready to Use Digital VIPR (head only) ROC-9840, Roberts Oxygen Ready to Use Digital VIPR System (with E-size…
Western/Scott Fetzer Company
FDA Devices Moderate Apr 19, 2023
Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis
Coloplast Manufacturing US, LLC
FDA Devices Moderate Apr 19, 2023
ProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 706100 and 706110
Philips North America Llc
FDA Devices Moderate Apr 19, 2023
Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human anatomy Model Number : 712201
Philips North America Llc
FDA Devices Moderate Apr 19, 2023
DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204
Philips North America Llc
FDA Devices Moderate Apr 19, 2023
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 …
Shanghai United Imaging Healthcare Co., Ltd.
FDA Devices Moderate Apr 19, 2023
Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis
Coloplast Manufacturing US, LLC
FDA Devices Critical Apr 19, 2023
Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004
Fresenius Kabi USA, LLC
FDA Devices Moderate Apr 19, 2023
BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD
Bio-Rad Laboratories, Inc.
FDA Devices Moderate Apr 19, 2023
Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
Coloplast Manufacturing US, LLC
FDA Devices Moderate Apr 19, 2023
Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis
Coloplast Manufacturing US, LLC
FDA Devices Moderate Apr 19, 2023
Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A
Merit Medical Systems, Inc.
FDA Devices Moderate Apr 19, 2023
Chromic Gut Absorbable Sutures, SURGIGUT* 0 CHR GS-25 90CM X36 (CG-904), SURGIGUT* 1 CHR GS-24 90CM X36 (CG-915), CHROMIC GUT 4-0 75CM V20 (GG-121), …
Covidien, LP
CPSC Moderate Apr 13, 2023
Moen Recalls Flo Battery Back-Ups for Flo Smart Water Monitors Due to Fire Hazard
Moen Incorporated, of North Olmsted, Ohio
FDA Devices Moderate Apr 12, 2023
CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE
Terumo Cardiovascular Systems Corporation
FDA Devices Moderate Apr 12, 2023
Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel, for the attended or…
Remote Diagnostic Technologies Ltd.
FDA Devices Moderate Apr 12, 2023
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,1PRT QUICK Catalog number: 5921-030-135NS Indicated for use in surgica…
Stryker Corporation
FDA Devices Moderate Apr 12, 2023
VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000
Maquet Cardiovascular, LLC
FDA Devices Moderate Apr 12, 2023
Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; b) GRAFTON T50306 DBF INJECT 6CC, REF T50306; c) GRAFTON T50309 …
Medtronic Sofamor Danek USA Inc
FDA Devices Critical Apr 12, 2023
FreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the FreeStyle Libre 2 Flash Glucose Monitoring System
Abbott Diabetes Care, Inc.
FDA Devices Moderate Apr 12, 2023
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,2PRT QUICK Catalog number: 5921-030-235NS Indicated for use in surgi…
Stryker Corporation
FDA Devices Moderate Apr 12, 2023
Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Number H5GT-060
CooperSurgical, Inc.
FDA Devices Moderate Apr 12, 2023
Medtronic Grafton Matrix: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF S42200; b) DBM S42210 GRAFTON 2.5CMX5CM 2EA MATRIX, REF S42210; c) DB…
Medtronic Sofamor Danek USA Inc
FDA Devices Moderate Apr 12, 2023
VASOVIEW HEMOPRO, OUS, Endoscopic Vessel Harvesting System, Model Number C-VH-3000-W
Maquet Cardiovascular, LLC
FDA Devices Critical Apr 12, 2023
FreeStyle Libre Reader, REF: 71936-01, 71937-01, 71938-01 a component of the FreeStyle Libre 14 Day Flash Glucose Monitoring System
Abbott Diabetes Care, Inc.
FDA Devices Moderate Apr 12, 2023
Medtronic Grafton Crunch a) DBM S44105 GRAFTON 5CC CRUNCH, REF S44105; b) DBM S44115 GRAFTON 15CC CRUNCH, REF S44115; c) DBM T44105 5CC GRAFTON…
Medtronic Sofamor Danek USA Inc
FDA Devices Moderate Apr 12, 2023
Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-term neurological monitoring system that collects, displays, and stores mul…
Moberg Research, Inc.
FDA Devices Moderate Apr 12, 2023
Medtronic XPANSE Bone Insert: a) DBM T600106 XPANSE SMALL-C 6, REF T600106; b) DBM T600206 XPANSE MEDIUM-C 6, REF T600206; c) DBM T600209 XP…
Medtronic Sofamor Danek USA Inc
FDA Devices Moderate Apr 12, 2023
Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile
Biosense Webster, Inc.
FDA Devices Moderate Apr 12, 2023
Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.
Abbott Molecular, Inc.
FDA Devices Moderate Apr 12, 2023
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1 BLA,1PRT QUICK Catalog number: 5921-218-135NS
Stryker Corporation
FDA Devices Moderate Apr 12, 2023
Medtronic Grafton Gel: a) DBM S41120 GRAFTON GEL 1CC, REF S41120; b) DBM S41150 GRAFTON GEL 10CC, REF S41150; c) DBM T41110 0.5CC GRAFTON GE…
Medtronic Sofamor Danek USA Inc
FDA Devices Moderate Apr 12, 2023
Medtronic Grafton Orthoblend: a) DBM S44125 5CC ORTHOBLEND LARGE DEFECT, REF S44125; b) DBM S44135 15CC ORTHOBLEND LARGE DEFECT, REF S44135; c) …
Medtronic Sofamor Danek USA Inc
FDA Devices Moderate Apr 12, 2023
CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC
Terumo Cardiovascular Systems Corporation
FDA Devices Critical Apr 12, 2023
Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S11, UDSX500S11F, UDSX700S11, UDSX700S11F, UFRX500S14. Used to deliver p…
Philips Respironics, Inc.
FDA Devices Moderate Apr 12, 2023
CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30
Terumo Cardiovascular Systems Corporation
FDA Devices Moderate Apr 12, 2023
Medtronic Grafton Plus Paste a) DBM S45001 GRAFTON 1CC PASTE, REF S45001; b) DBM S45005 GRAFTON 5CC PASTE, REF S45005; c) DBM S45010 GRAFTON…
Medtronic Sofamor Danek USA Inc
FDA Devices Moderate Apr 12, 2023
Medtronic Grafton Matrix Strips: a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STRPS, REF S42275; b) DBM S42280 8MMX1CMX20CM 2EA MATRX STRPS, REF S42280…
Medtronic Sofamor Danek USA Inc
FDA Devices Moderate Apr 12, 2023
Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101; b) DBM S43102 GRAFTON 1CC PUTTY, REF S43102; c) DBM S43103 GRAFTON 2…
Medtronic Sofamor Danek USA Inc
FDA Devices Moderate Apr 12, 2023
Medtronic Grafton DBF: a) PUTTY T50101 GRAFTON DBF 1CC, REF T50101; b) PUTTY T50101INT GRAFTON DBF 1CC, REF T50101INT; c) PUTTY T50103 GRAFTO…
Medtronic Sofamor Danek USA Inc
FDA Devices Moderate Apr 5, 2023
Instructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical Instruments: (1) Part #A2800-26, Backlund Catheter In…
Elekta Instrument AB
FDA Devices Moderate Apr 5, 2023
ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material # 10849000.
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Apr 5, 2023
ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Par…
Instrumentation Laboratory
FDA Devices Moderate Apr 5, 2023
PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825; c) 50 tubes, REF 597850; d) 25 grams, REF 5970025; e) 1000 kilogram, R…
Entopsis , Inc.
FDA Devices Moderate Apr 5, 2023
ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number…
Instrumentation Laboratory