Medical Device Recalls

IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25).

Fresenius Kabi USA, LLC

Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

B-K Medical A/S

epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of heparinize

Siemens Healthcare Diagnostics Inc

Compress Device Segmental Anchor Plug, 14 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previ

Biomet, Inc.

Brand Name: AART Calf Implant Product Name: Calf Implant Model/Catalog Number: 502-103 - Calf Implant style 1 size 3

DSAART LLC

Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB841. Used in Car

Medtronic Perfusion Systems

KWIK-STIK(TM), Streptococcus pneumoniae derived from ATCC(R) 49619(TM), packaged as follows: a. KWIK-STIK(TM) 2 Pac

Microbiologics Inc

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584712;

Beaver Visitec International, Inc.

The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.

DIXI MEDICAL USA

HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607

Advanced Bionics, LLC

Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210

Philips Ultrasound, Inc.

Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85

Datascope Corp.

American Contract System Convenience Kit, D & C PACK, Model/Catalog Number: LLPD90H

American Contract Systems Inc

CoolCurve ZELTIQ Vaccum Applicator REF BRZ-AP1-062-000

Zeltiq Aesthetics, Inc

To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural le

Olympus Corporation of the Americas

Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis Valve Metal Insertion Tool Torque Device REF

Merit Medical Systems, Inc.

Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q

St. Jude Medical, Cardiac Rhythm Management Division

Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end ca

Cook Incorporated

QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC

Quidel Corporation

Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate,

RECORDATI RARE DISEASES INC.

Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleeve and 5 - 10 mm reducer, Product Number

Covidien, LP

TDC VELOCE", 27G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT27, 9311.27G01, 9311.27G02, 9311.27K01, 931

D.O.R.C. Dutch Opthalmic Research Center Intl B.V.

FLIXENE, 7X40, 1GDS, GW. Single-Ended Slider GDS. Vascular graft

Atrium Medical Corporation

Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/

Olympus Corporation of the Americas

Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum

Princeton Biomeditech Corp

ECONO STERILE medical procedure kits labeled as: ECONO STERILE KOGAN ENDOCERV SPEC STER CS/5, Model Number 96-4142A,

Sklar Instruments

Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological mapping of cardiac structures. Medline Item Numbe

Medline Industries, LP

SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented

Waldemar Link GmbH & Co. KG (Mfg Site)

eL18-4 Transducer Probe

Philips Ultrasound, Inc

BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150, BF-1T60, BF-P150 BF-P60 and EVIS EXERA BRONCHOVIDEOSCOPE OLYM

Olympus Corporation of the Americas