Medical Device Recalls

FLIXENE, 4-7X45, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft

Atrium Medical Corporation

Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument available for use in t

Synthes (USA) Products LLC

MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-11142-LC2 UDI code: (01)10801902206

ARROW INTERNATIONAL, LLC

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085265022; cardiac catheter

Boston Scientific Corporation

REF: 123400,Bard Urologist's Tray, For the Obstructed Urethra

C.R. Bard Inc

Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog

Olympus Corporation of the Americas

Everest MI XT Inner Dilator, Catalog Number 5101-90167

K2M, Inc

Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty

Corin Ltd

Boston Scientific CSK Electrodes: REF: CSK-TC10, CSK Electrode, STAINLESS STEEL, 10 cm x 28 ga (0.36 mm) REF: CSK-TC10

Boston Scientific Neuromodulation Corporation

CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP

Smiths Medical ASD Inc.

URINE COLLECTION VHC, SKU DYLAB1016; Component No. 503581

MEDLINE INDUSTRIES, LP - Northfield

Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: IV START KIT LAB DRAW-SH, REF

MEDLINE INDUSTRIES, LP - Northfield

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

B Braun Medical Inc

IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI Magnet, Vida

IMPRIS Imaging Inc

Colonovideoscope Model CF-H180AL

Olympus Corporation of the Americas

Pet Allergy Test

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NeoSpan¿ SuperElastic Compression Staple w/Instruments Catalog Number and Product Name T50 SN010 NeoSpan¿ SuperElasti

In2bones USA, LLC

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001177;

Beaver Visitec International, Inc.

Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG

Exactech, Inc.

INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup

Innomed, Inc.

MEDLINE DENTAL PACK, REF DYNJ66983. Convenience kit used in medical procedures.

MEDLINE INDUSTRIES, LP - Northfield

Brand Name: PROBEAT Product Name: PROBEAT-FR Model/Catalog Number: N/A Software Version: N/A Product Description: Th

Hitachi America, Ltd., Particle Therapy Division

ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Desc

Alcon Research LLC

GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1

Medacta Usa Inc

SIGNA Premier - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high sign

GE Healthcare, LLC

Medline Convenience kits, labeled as: 1) TRACHEOTOMY TRAY, Pack Number DYNDA1894; 2) TRACHEOSTOMY, Pack Number DYNJ

MEDLINE INDUSTRIES, LP - Northfield

BD SE Burette Set 20 Drops 2 Injection Ports Vented/NonVented, REF: 72103E-0006

CAREFUSION

APD Drain Manifold

Baxter Healthcare Corporation

Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.