FDA Device
Medical devices recalls
Latest medical devices recall events with affected products, hazards, remedies, and official sources.
FDA Device
FDA Device
FDA Device
UrgentFDA Class I
MEDLINE medical procedure convenience kit labeled as: 1) TOTAL KNEE-LF, Medline kit SKU CDSOPT590T
Medline Industries, LP
FDA Device
FDA Device
FDA Device
UrgentFDA Class I
Pack Angiography NCMC 3/Cs BANNER, REF: NCAG62I, containing Medline Namic Angiographic Star Off Handle Manifolds
Medical Action Industries, Inc. 306
FDA Device
FDA Device
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ElevatedFDA Class II
Rapid Refill Continuous Injection System, UPN M00566001
Boston Scientific Corporation
FDA Device
FDA Device
ElevatedFDA Class II
EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77722
Medtronic Perfusion Systems
FDA Device
FDA Device
FDA Device
ElevatedFDA Class II
Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001
Boston Scientific Corporation
FDA Device
ElevatedFDA Class II
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Nerve Block Tray - RX, Part Number AMS13975A
Windstone Medical Packaging, Inc.
FDA Device
FDA Device
ElevatedFDA Class II
P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0
Paragon 28, Inc.
FDA Device
ElevatedFDA Class II
MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)
Medtronic MiniMed, Inc.
FDA Device
ElevatedFDA Class II
Olympus High Flow Insufflation Unit - UHI-4
Olympus Corporation of the Americas
FDA Device
ElevatedFDA Class II
L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm, REF: 384620
Argon Medical Devices, Inc
FDA Device
FDA Device
ElevatedFDA Class II
FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, IFU Reference Number LBL1062
Boston Scientific Corporation
FDA Device
ElevatedFDA Class II
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401
Boston Scientific Corporation
FDA Device
ElevatedFDA Class II
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401
Boston Scientific Corporation
FDA Device
ElevatedFDA Class II
Medline medical convenience kits labeled as: 1) SHOULDER PACK, Medline Kit SKU DYNJ39590O
Medline Industries, LP
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FDA Device
ElevatedFDA Class II
Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device
Orthofix U.S. LLC
FDA Device
FDA Device
ElevatedFDA Class II
Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267
Medline Industries, LP
FDA Device
ElevatedFDA Class II
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons
Medline Industries, LP
FDA Device
ElevatedFDA Class II
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Pack Number AMS12206
Windstone Medical Packaging, Inc.
FDA Device
ElevatedFDA Class II
Pipeline Flex Embolization Device with Shield Technology, 3
Micro Therapeutics, Inc.
FDA Device
ElevatedFDA Class II
Optima XR200amx, Mobile Digital-Ready Radiographic System
GE Medical Systems, LLC
FDA Device
FDA Device
ElevatedFDA Class II
The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000
Maquet Cardiovascular, LLC
FDA Device
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FDA Device
ElevatedFDA Class II
Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115
Medtronic Perfusion Systems
FDA Device
FDA Device
ElevatedFDA Class II
Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1
Karl Storz Endoscopy
FDA Device
FDA Device
ElevatedFDA Class II
SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
Alphatec Spine, Inc.
FDA Device
FDA Device
ElevatedFDA Class II
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Portable blood analyzer system
Instrumentation Laboratory
FDA Device
FDA Device
FDA Device
ElevatedFDA Class II
Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb
Olympus Corporation of the Americas
FDA Device
ElevatedFDA Class II
Brand Name: Silent Nite Product Name: Silent Nite Sleep Appliance Model/Catalog Number: SILNT Product Description: Silent Nite Sleep Appliance is a mandibular advancement device (M
Prismatik Dentalcraft, Inc.