Medical Device Recalls

Baxter Epiphany Cardio Server E3 ECG Management System Servers with software versions: a) v6.1.x, b) v6.2.x, c) v7.0.x.

Baxter Healthcare Corporation

ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27

Abbott Laboratories

HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205

Heartware, Inc.

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. PLASTICS FREE FLAP, Medline

Medline Industries, LP

Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5 Syst

LivaNova Deutschland GmbH

Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E8

GE Medical Systems, LLC

DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20

Beckman Coulter, Inc.

Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic Navigation System - 230V 50Hz SYS-4000 SPiN

Olympus Corporation of the Americas

Brand Name: MEDLINE Product Name: SYR 10ML L/L RED CONT Model/Catalog Number: 91856 Product Description: NON-Sterile

Jiangsu Shenli Medical Production Co., Ltd.

48" Lead Wires, Replacement Part Number: 1067724-4

EBI, LLC

Zoll, REF: 8700-0791-01 (IC-4593), Premium Access Kit QUATTRO, Intravascular Heat exchange Catheter Kit (Heparin), with

ZOLL Circulation, Inc.

S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and Critical Care hospital environments,

Stryker Medical Division of Stryker Corporation

QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic acids in molecu

Qiagen Sciences LLC

TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement Catalog Number: 5532-G-413-E

Howmedica Osteonics Corp.

HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Produc

Philips North America Llc

TEMPO REAGENTS TEMPO CONTROL KIT , CATALOG 80000

Biomerieux Inc

KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K

Microbiologics Inc

SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray, 5MM X 10FT 3.05M, REF: 0233-050-200

Stryker Corporation

Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surg

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Up Model Number 11061620. Running on servers with syng

Siemens Medical Solutions USA, Inc

Change Healthcare Radiology Solutions software version 14.2.2

CHANGE HEALTHCARE CANADA COMPANY

Colonoscope-indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and il

Aizu Olympus Co., Ltd.

nanoDot D2DNN, Model Numbers: a) 18105-000; b) 18105-KIT; radiation monitoring dosimeter used with the microSTAR re

Landauer

Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality

Surgical Theater Inc

Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434

Medicalplastic S.R.L.

Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-200-005

Stryker Corporation

Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-01C, (2) G5S-02C, (3) G5S-10C, (4) G5S-

ZOLL Medical Corporation

HENRY SCHEIN, EXTREMITY PACK, Item No.570-2946

Stradis Medical, LLC dba Stradis Healthcare

Ti-Cron Coated Braided Polyester Suture Product Description 88862775-31 TICRON* 4-0 BLU 75CM CV327DA 88862880-41 TICR

Covidien, LP

Medline procedural kits labeled as: 1) MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 2) NICU CIRCUMCISION TRAY W/

MEDLINE INDUSTRIES, LP - Northfield