Medical Device Recalls

DigitalDiagnost 4 (1) High Performance, (2) Flex/Value; Model Number: (1) 712031, (2) 712032;

Philips Medical Systems DMC GmbH

AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507

Avanos Medical, Inc.

Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455

DiaSorin Molecular LLC

Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781045

TELEFLEX LLC

Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, Model Numbe

Datascope Corp.

Ventlab, LLC RescuMed manual resuscitators with integrated manometer, multiple accessory configurations to include: 1

SunMed Holdings, LLC

Medline Convenience kits labeled as: 1) KIT GENERAL CLOSURE , Pack Number DYKMBNDL200A ; 2) KIT GENERAL CLOSURE , P

MEDLINE INDUSTRIES, LP - Northfield

MEDLINE ARTERIAL BUNDLE NO CATHETER, REF ART995

MEDLINE INDUSTRIES, LP - Northfield

HF Resection Electrodes, Model Numbers WA22602S, WA22603S, WA22621S and WA22657S

Olympus Corporation of the Americas

Cardinal Health Poly-Reinforced Surgical Gowns X-large SKU: 9040

Cardinal Health

Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386, 1286A-CAN

Thoratec Corp.

Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 Software Version: N/A Product Descripti

CooperSurgical, Inc.

TRACKMASTER, TREADMILL GE T2100-ST1 110VV, MODEL NUMBER 317-07926GE

Full Vision Inc

Medline Convenience kits used for various procedures: 1) BASIC CATARACT, Model Number: DYNJ41097A; 2) PK EYE, Model N

MEDLINE INDUSTRIES, LP - Northfield

Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Versi

Hologic, Inc

Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE

Karl Storz Endoscopy

ACS IR - Angio Pack

American Contract Systems, Inc.

Product Name: Nasal Jejunal Feeding Tube REF: NJFT-10

Wilson-Cook Medical Inc.

LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 45MM Item Number: 15-2028/04

Linkbio Corp.

Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM50, iM60, iM70, iM80 Product Description: The

Edan Diagnostics

Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis

Stryker Leibinger GmbH & Co. KG

8MM,LONG BIPOLAR GRASPER,IS4000 REF 471400

Intuitive Surgical, Inc.

Arthroscopy Pack, MSKA45A; Medical convenience kit

American Contract Systems, Inc.

OEC Elite mobile C-arm - Product Usage: intended to provide fluoroscopic and digital spot images of the patient anatomy,

GE OEC Medical Systems, Inc

Brand Name: SenTiva DUO" Product Name: VNS Therapy¿ SenTiva DUO", Model 1000-D Model/Catalog Number: 1000-D Software

LivaNova USA, Inc.

¿regard SHOULDER PK, GS00125U, Item Number 880120021; ortho surgery convenience kit

ROi CPS LLC

ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RMC

Cordis US Corp

Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2188

Cardinal Health 200, LLC

cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on the cobas 6800/8800 Systems; Mat

Roche Molecular Systems, Inc.

BD ADD-ON Burette Set V/NV Needle-Free Valve, REF: 82113E-0006

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