Medical Device Recalls

HeartWare HVAD Pump Kit, REF 1103

Heartware, Inc.

Medline Convenience Kits: 1) ENDO KIT W/SYRINGE, Model Number: DYKE1743; 2) BGMC ANGIOGRAPHY PACK-LF, Model Number: D

Medline Industries, LP

StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems

Medtronic Navigation, Inc.

Serotonin Test

GET TESTED INTERNATIONAL AB

Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode, Reusable Patient Return Electrode, M

Megadyne Medical Products, Inc.

GE Nuclear Medicine 600/800 series systems, specifically: a) 850, b) 850 / Dismount, c) 850 3/8 inch NM Gantry, d) 86

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

Description/REF: ACCESS TRAY/ASK-04001-SUH-S; ACCESS TRAY/ASK-04001-VM1; STIMUCATH SFTY KIT: 19G CTH, 17Gx4CM NDL/AB-

ARROW INTERNATIONAL, LLC

PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.

TEI Biosciences, Inc.

Halyard CATH LAB kit. Model Number: SACL75AM.

AVID Medical, Inc.

Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Tray, Part Numbers: a) REF 1-10012-100, SIZE 1-LEFT M

Smith & Nephew, Inc.

MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: HYSTERO PACK, Model Number DYNJ61448A

MEDLINE INDUSTRIES, LP - Northfield

Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and treatment in urological applications.

Olympus Corporation of the Americas

Artis zee biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interve

Siemens Medical Solutions USA, Inc

Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF): 781178.

Philips North America

LAPAROSCOPY PACK. Medical convenience kit.

AVID Medical, Inc.

Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0

Datascope Corp.

nanoDot D2DXN, Model Numbers: a) 03061-1MO; b) 03061-3MO; c) 03061-OTO; d) 03061-SMO; radiation monitoring dosi

Landauer

Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781055

TELEFLEX LLC

Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60, BF-1T60

Olympus Corporation of the Americas

GENERAL ANGIO PACK , Model Nos LLAP75G LLAP75G-01 LLAP75G-02 LLAP75G-03

American Contract Systems Inc

ADVANTA VXT, 6X100, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft

Atrium Medical Corporation

VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a

Ortho-Clinical Diagnostics, Inc.

Leica Biosystems Cryostat Model Number CM1510 S, Material Numbers: a) 491510C002, b) 1491510C003; for freezing and sect

LEICA BIOSYSTEMS NUSSLOCH GMBH

DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDSLM45

Collagen Matrix, Inc.

Maquet G8 / G8E OR Light Systems, Model Numbers and Catalog Numbers G8 LC E - ARD568131211C, G8G8 DF E - ARD568121111C,

Getinge Usa Sales Inc

Veritas Advanced Infusion Packs. Used in ophthalmic procedures.

Johnson & Johnson Surgical Vision, Inc.

Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201

Flower Orthopedics Corporation

Cannulated graduated drill bit 1.9 mm diameter, with AO QC system, REF: INS-114 for use in orthopedic surgery.

NEOSTEO

Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG

ICU Medical Inc.

Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-1

Spacelabs Healthcare, Inc.