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1,784 recalls
High RiskFDA
Abbott Medical
Abbott Proclaim Plus 7 Implantable Pulse Generator, REF 3672, Sterile EO, Rx Only
Medical Implants·1,086 affected·May 16, 2024
High RiskFDA
Abbott Medical
Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3670, Sterile EO, Rx Only
Medical Implants·8,401 affected·May 16, 2024
High RiskFDA
Abbott Medical
Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY
Medical Implants·302 affected·May 16, 2024
High RiskFDA
Abbott Medical
Abbott Proclaim DRG Implantable Pulse Generator, REF 3664, Sterile EO, Rx Only
Medical Implants·21,843 affected·May 16, 2024
High RiskFDA
Abbott Medical
Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3671, Sterile EO, Rx Only
Medical Implants·38 affected·May 16, 2024
High RiskFDA
Abbott Medical
Abbott Proclaim 5 Implantable Pulse Generator, REF 3665, Sterile EO, Rx Only
Medical Implants·1,119 affected·May 16, 2024
High RiskFDA
Abbott Medical
Proclaim 7 Elite Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only
Medical Implants·30,673 affected·May 16, 2024
High RiskFDA
Synthes (usa) Products Llc
STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing of screw implants during orthopaedic s...
Medical Implants·261 affected·Apr 25, 2024
High RiskFDA
Medtronic Inc.
EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defibrillator
Medical Implants·14 affected·Apr 16, 2024
High RiskFDA
Medtronic Inc.
COBALT DR MRI SureScan, Model Number DDPB3D1, Implantable Cardioverter Defibrillator
Medical Implants·9 affected·Apr 16, 2024
High RiskFDA
Medtronic Inc.
COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator
Medical Implants·14 affected·Apr 16, 2024
High RiskFDA
Medtronic Inc.
Cobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter Defibrillator
Medical Implants·5 affected·Apr 16, 2024
High RiskFDA
Medtronic Inc.
COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter Defibrillator
Medical Implants·8 affected·Apr 16, 2024
High RiskFDA
Medtronic Inc.
MIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter Defibrillator
Medical Implants·13 affected·Apr 16, 2024
High RiskFDA
Medtronic Inc.
COBALT DR MRI SureScan, Model Number DDPB3D4, Implantable Cardioverter Defibrillator
Medical Implants·36 affected·Apr 16, 2024
High RiskFDA
Medtronic Inc.
CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibrillator
Medical Implants·9 affected·Apr 16, 2024
High RiskFDA
Medtronic Inc.
MIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter Defibrillator
Medical Implants·26 affected·Apr 16, 2024
High RiskFDA
Medtronic Inc.
COBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter Defibrillator
Medical Implants·4 affected·Apr 16, 2024
High RiskFDA
Medtronic Inc.
PRIMO MRI DR SureScan, Model Number DDMD3D1, Implantable Cardioverter Defibrillator
Medical Implants·2 affected·Apr 16, 2024
High RiskFDA
Medtronic Inc.
MIRRO MRI VR SureScan, Model Number DVME3D1, Implantable Cardioverter Defibrillator
Medical Implants·6 affected·Apr 16, 2024
High RiskFDA
Preat Corp
9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too be used in conjunction with an endosseous dental implant fixt...
Medical Implants·7 affected·Apr 10, 2024
High RiskFDA
Ossur H / F
RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component
Medical Implants·0 affected·Mar 25, 2024
High RiskFDA
Ossur H / F
RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic component
Medical Implants·1 affected·Mar 25, 2024
High RiskFDA
Ossur H / F
RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
Medical Implants·107 affected·Mar 25, 2024
High RiskFDA
Ossur H / F
RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
Medical Implants·143 affected·Mar 25, 2024
CriticalFDA
Thoratec Corp.
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
Medical Implants·882 affected·Mar 1, 2024
High RiskFDA
Seaspine Orthopedics Corporation
Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle...
Medical Implants·444 affected·Feb 28, 2024
High RiskFDA
Bolton Medical Inc.
RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system, IFU, and patient tracking card, sterile: (a) Pa...
Medical Implants·21 affected·Feb 22, 2024
CriticalFDA
Thoratec Corp.
HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemptio...
Medical Implants·22,663 affected·Feb 19, 2024
CriticalFDA
Thoratec Corp.
HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft with Bend Relief REF 103393 2. HeartMate II LV...
Medical Implants·2,240 affected·Feb 19, 2024
High RiskFDA
Medtronic Inc.
Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090
Medical Implants·65 affected·Feb 16, 2024
High RiskFDA
Seaspine Orthopedics Corporation
Mariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial Head, REF: MX1-000030; Mariner RDX Deformity Head, REF: MX1...
Medical Implants·1,579 affected·Feb 15, 2024
High RiskFDA
Waldemar Link Gmbh & Co. Kg (mfg Site)
SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented
Medical Implants·0 affected·Feb 6, 2024
High RiskFDA
Waldemar Link Gmbh & Co. Kg (mfg Site)
SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented
Medical Implants·153 affected·Feb 6, 2024
High RiskFDA
Waldemar Link Gmbh & Co. Kg (mfg Site)
SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented
Medical Implants·382 affected·Feb 6, 2024
High RiskFDA
W.l. Gore & Associates, Inc.
GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm; with holes; and (2) Cat...
Medical Implants·24 affected·Jan 19, 2024
High RiskFDA
Impulse Dynamics (usa) Inc
OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite
Medical Implants·1,469 affected·Jan 5, 2024
High RiskFDA
Waldemar Link Gmbh & Co. Kg (mfg Site)
Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total knee arthroplasty procedure. P...
Medical Implants·1 affected·Nov 30, 2023
High RiskFDA
American Contract Systems, Inc.
Procedural convenience kits and trays, cardiac, labeled as: a) EP LAB BI V IMPLANT PACK, kit number AGBI64J; b) LAB DEVICE IMPLANT, ...
Medical Implants·12,291 affected·Nov 29, 2023
High RiskFDA
Medtronic Inc.
Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
Medical Implants·1 affected·Nov 20, 2023
High RiskFDA
Covidien Lp
AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for fixation of prosthetic material to soft tissue in ...
Medical Implants·54 affected·Nov 16, 2023
CriticalFDA
Medline Industries, Lp - Northfield
MEDLINE Kits, trays, and packs labeled as follows: a) DIALYSIS FISTULA KIT, REF DYNDC3106, b) ENDO KIT, REF DYKE1346D, c) ENDO KIT...
Medical Implants·0 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
MEDLINE Kits, trays, and packs labeled as follows: a) ARTERIAL LINE PACK, REF DYNJ65208A; b) CANCER SERVICE PORT KIT, REF DT22710; ...
Medical Implants·0 affected·Nov 15, 2023
High RiskFDA
Heartware, Inc.
PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103
Medical Implants·7,438 affected·Oct 31, 2023
High RiskFDA
Heartware, Inc.
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205
Medical Implants·126 affected·Oct 31, 2023
High RiskFDA
Heartware, Inc.
PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP
Medical Implants·126 affected·Oct 31, 2023
High RiskFDA
Heartware, Inc.
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100
Medical Implants·45 affected·Oct 31, 2023
High RiskFDA
Heartware, Inc.
PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104
Medical Implants·10,287 affected·Oct 31, 2023