Medical Device Recalls

XScribe Cardiac Stress Testing System, version 6, with below product names and codes: a) XS6/RS6 REVIEW WKSTN KIT, XR-6A

Baxter Healthcare Corporation

Male-Female Midsection with the following sizes and model numbers. a. Male-Female Midsection, 40mm, 1 EACH; Model Num

Onkos Surgical, Inc.

Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter-ULT12.0-38-45-P-6S-CLM-RH-ntended for percutaneous

Cook Incorporated

Zoll REF: 8700-0783-01 (IC-4593), QUATTRO Intravascular Heat Exchange Catheter Kit Custom Luer Applause Heparin, Sterile

ZOLL Circulation, Inc.

The FAST System and the FAST PBC Prep Cartridge together are a closed, rapid and automated sample preparation system for

Qvella Corporation

Pneupac paraPAC plus 300 ventilator kit, REF P300NXX

Smiths Medical ASD Inc.

MultiLab Series II LHS TI & ERGO non-invasive vascular diagnostic device, Model Number 11949-0000-01

Unetixs Vascular, Inc.

Meera Mobile Operating Table-to support and position the patient immediately before, during and after surgical intervent

Getinge Usa Sales Inc

Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;

Siemens Healthcare Diagnostics, Inc.

GE Healthcare Carestation 650c A1, Model/REF Number 1012-9655-200. Anesthesia system.

GE Medical Systems China Co., Ltd.

Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.

Philips Respironics, Inc.

S12-4 Transducer Probe

Philips Ultrasound, Inc

S7-2t Transducer Probe

Philips Ultrasound, Inc

Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monitor 5

Philips North America Llc

FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The FreeStyle Libre 3 Plus sensor is a component

Abbott Diabetes Care, Inc.

Hydroxybutyrate LiquiColor Tests - includes 3 bottles (1 of each size, 3mL, 8.5mL, and 50mL)

MEDLINE INDUSTRIES, LP - Northfield

Beach Chair Clamp, BEACH CHAIR SHLDER POSITIONER CMPT, REF A-90013, #800104. Component to position and support the pat

Baxter Healthcare Corporation

Design Options Spinal Tray Spinal Needle Anesthesia procedure kits: Material Description (Material Number): SSK H M C

B Braun Medical Inc

BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 4000 Main / 10885403512629 / 303 BD Pyxis"

CareFusion 303, Inc.

LARGE PRIMARY REV.TIB.INSERT- DURACON Intended for knee replacement Product Number: 6637-4-231

Howmedica Osteonics Corp.

BD Texium: 3 mL, REF: MY8003-0006; 5 mL, REF: MY8005-0006; 10 mL, REF: MY8010-0006; 20 mL, REF: MY8020-0006; 30 mL, REF:

BD SWITZERLAND SARL

Karl Storz Udel Sterilization Tray Instructions for Use, Tray Part Number/Description: 39301ACTS/CAMERA TRAY (STERRAD, I

Karl Storz Endoscopy

Puritan Bennett 980 Series Ventilator, 980X3JADIJJ

Covidien Llc

Wright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 5201120008, non-sterile, a component of the OR

Wright Medical Technology, Inc.

HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm; L: 60 cm Indicated for use in the replacement

Maquet Cardiovascular, LLC

CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030

INSPIREMD Inc

EVERA MRI S DR SureScan, Model Number DDMC3D1, Implantable Cardioverter Defibrillator

Medtronic Inc.

Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope system

Leica Microsystems, Inc.

Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO

Abbott Vascular

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:

Zimmer, Inc.