Medical Device Recalls

VITROS XT7600 Integrated System

Ortho-Clinical Diagnostics, Inc.

Samsung Digital Diagnostic Mobile X-ray System, Model GM85.

NeuroLogica Corporation

ICD COBALT XT DR MRI IS1 DF1, Model Number DDPA2D1; Implantable Cardioverter Defibrillators

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Philips OmniLab Advanced + with Heated Tube Humidifier, Rx Only. To provide noninvasive ventilation support for patient

Philips Respironics, Inc.

remel BactiDrop Acridine Orange, REF 21502, 50 per package.

Remel, Inc

Medline Convenience Kits: 1) IV START KIT LAB DRAW-SH, Model Number: CDS860014P; 2) IV START KIT, Model Number: DYKM1

Medline Industries, LP

Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN

OrthoPediatrics Corp

Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Rev 20, 21, and 23

Draeger Medical Systems, Inc.

HENRY SCHEIN, Amnio Tray, Item No.570-3059,

Stradis Medical, LLC dba Stradis Healthcare

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DELUXE PRE OP KI

Medline Industries, LP

Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5; M001314011 IMAGER II/5/ST/100/038 BX5;

Boston Scientific Corporation

Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM

Philips North America

EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic

Phadia Ab

Sopha Medical Vision (SMV) DSXi/DST-XLi,/ DST-XL/ DSTi; dual-head nuclear medicine gamma camera designed specifically fo

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

AlluraXperFD20/10 System Code: (1) 722029

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. neonatal transport system

Draeger Medical Systems, Inc.

VITROS XT 7600 Integrated System Product Code 6844461 Running Software Version 3.8.0

Ortho-Clinical Diagnostics, Inc.

PERIPHERAL BLOOD CULTURE DRAW, REF DYNDH1561

MEDLINE INDUSTRIES, LP - Northfield

Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical

GE Healthcare

Carina Sub-Acute Care Ventilator

Draeger Medical, Inc.

Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4718

Hobbs Medical, Inc.

AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kits

North American Rescue LLC.

Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170120

TELEFLEX LLC

EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number

Medtronic Perfusion Systems

CURAD FIRST AID KIT, SKU 999037

Family Dollar Stores, Llc.

RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-931

Howmedica Osteonics Corp.

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

B Braun Medical Inc

Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780035

TELEFLEX LLC

Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 7821

Philips North America

MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system.

Mobius Imaging, LLC