Medical Device Recalls

Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146

Philips North America

Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephro

Olympus Corporation of the Americas

Abbott Proclaim XR 7 Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only

Abbott Medical

VIDAS CLINICAL QCV-QUALITY CONTROL VIDAS 60T, CATALOG 30706

Biomerieux Inc

Aeris Balloon Dilation Catheter

Bryan Medical Inc

PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS

Edwards Lifesciences, LLC

MEDLINE procedure kits labeled as follows: 1) ECHOSTIM BLOCK SET, REF DYNJRA9043S; 2) ULTRASOUND BLOCK PREP TRAY, REF

MEDLINE INDUSTRIES, LP - Northfield

IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers (IMMULITE 2000/

Siemens Healthcare Diagnostics, Inc.

ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S

ICU Medical, Inc.

Cardinal Health INSULATED GEL PACK REUSABLE, EXTRA LARGE, Cat. 80600

Cardinal Health 200, LLC

POLIDENT DENTURE CLEANSERS 84 CT, SKU 901634 POLIDENT DENTURE CLNS TAB 28CT, SKU 906131

Family Dollar Stores, Llc.

EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180

Olympus Corporation of the Americas

Model Number 40KWFXPLUS.889, Mobile X-ray system

SEDECAL SA

Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2.

Cardinal Health 200, LLC

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS2.5 (5PK), REF H74908526572A2; cardiac catheter

Boston Scientific Corporation

Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450208.

DEPUY (IRELAND)

HENRY SCHEIN, Blue Tail Custom Pack, Item No.570-3091,

Stradis Medical, LLC dba Stradis Healthcare

MR RT Upgrades- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.

Philips North America Llc

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PEDIATRIC EP PACK, Model Number D

MEDLINE INDUSTRIES, LP - Northfield

Millenium Myosight; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only

Covidien

Regard, T AND A - Rogers, sterilized convenience kits

ROi CPS LLC

CAIRE Liberator 20, MODEL 13256195, Liquid Oxygen System Unit

Caire, Inc.

Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400J (IPN000308), cardiac pump

ARROW INTERNATIONAL Inc.

Coviden Monoject 60ml Syringe Luer-Lock Tip-used to inject fluid into or withdraw fluids from the body MMS Catalog Numb

Mckesson Medical-Surgical Inc. Corporate Office

Quick Strip Fabric Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number NON25650QS

Medline Industries, LP

COOK MEDICAL Spectrum¿ Central Venous Catheter Set: Reference Part Number C-UDLM-401J-ABRM-HC, Order Number G43983; R

Cook Incorporated

Access Total T4, REF 33800, IVD, thyroxine reagent assay.

Beckman Coulter, Inc.

LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number: 15-2230/13

Linkbio Corp.

OptiCross Coronary Imaging Catheter, REF H749518080120

Boston Scientific Corporation