Medical Device Recalls

SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malign

Cordis Corporation

Trocar Needle - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular a

Cook Incorporated

MR 7700, Magnetic Resonance System.

Philips North America Llc

Access Substrate, REF 81906, For use with the Access Immunoassay Systems

Beckman Coulter, Inc.

MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I

Chromsystems Instruments & Chemicals GmbH

Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2

DiaSorin Molecular LLC

BD Pyxis: MedStation ES (Main), REF: 323; MedStation ES Tower, REF: 352; Anesthesia Station ES, REF: 327; CII Safe ES

CareFusion 303, Inc.

Sterile Procedural Trays, labeled as the following: a. CARDIAC CATH PACK-LF; b. ANGIOGRAPHY-NS-LF; c. EP BA

MEDLINE INDUSTRIES, LP - Northfield

MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075W; 2) C-SECTION, REF CDS984261J; 3) C-S

Medline Industries, LP

DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF 480440

Intuitive Surgical, Inc.

Bronchial Microbiology Brush, Catalog Number 4310 and 4320. Microbial sampling is performed by compressing a spring as t

Hobbs Medical, Inc.

Cardinal Health Presource Kits: 1) LARYNGOSCOPY PACK, Catalog Number:SRIET0979N;

Cardinal Health 200, LLC

MEGADYNE MEGA 2000 Patient Return Electrode. used during electrosurgery

Megadyne Medical Products, Inc.

KARL STORZ - ENDOSKOPE, REF: 27002KP, Pediatric Uretero-Renoscope 7.3 Fr., NON STERILE, CE 0123

Karl Storz Endoscopy

Incisive CT- Whole-body computed tomography (CT) X-Ray System Model Number: 728143 (OUS)

PHILIPS HEADQUARTERS CAMBRIDGE

Medicina Oral Tip Syringe 1ml Code: OT01

Medicina Uk Ltd

NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2

Medtronic Xomed, Inc.

Philips Spectral CT on Rails. Model Number: 728334.

PHILIPS MEDICAL SYSTEMS

Philips S8-3t Transducer.

Philips Ultrasound, Inc

Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Eliti

Philips North America

RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-164-28U 28-N4-32-164-

Bolton Medical Inc.

Medline Leg bag, REF DYND12578

MEDLINE INDUSTRIES, LP - Northfield

Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 14 Fr/Ch (4.7 mm) Product Code: 3410 Intended fo

Cardinal Health

Alcon Custom Pak

Alcon Research, LTD.

WALLFLEX ESOPHAGEAL FC 18/23-25MMX10CM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System I

Boston Scientific Corporation

Philips L17-5 Ultrasound Transducer

Philips Ultrasound, Inc

smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9 Fr Introducer

Smiths Medical ASD, Inc.

ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 416976. For the management of stoma outpu

ConvaTec, Inc

1.5T SIGNA HDxt (HD28) MR System, Nuclear Magnetic Resonance Imaging System

GE Healthcare, LLC

Meijer STERILE saline wound wash, First Aid Cleansing Spray, 0.9% USP SODIUM CHLORIDE, 7.1FL OZ (210 mL), DBD-CAN,SPRAY,

Medline Industries, LP