Medical Device Recalls

Cardinal Health Presource Kits: 1) ACDF PACK, Catalog Number: SNEHBACSCA; 2) ACDF PACK, Catalog Number: SNEHBACSCB

Cardinal Health 200, LLC

Ingenia 1.5T, Magnetic Resonance System.

Philips North America Llc

Brand Name: EDAN Product Name: Fetal & Maternal Monitor Model/Catalog Number: F6, F9, F6 Express, F9 Express Product

Edan Diagnostics

Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180055

TELEFLEX LLC

Trevo Trak 21 Microcatheter, REF: 90338. TREVO NXT 3X32+TRAK21 2-PACK - CE, REF: 91412; TREVO NXT 4X28+TRAK21 2-PACK

Stryker Neurovascular

ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 402S0425, Bone fixation device

Wright Medical Technology, Inc.

BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER

Stryker Sustainability Solutions

Olympus Thunderbeat, 5 mm, 35 cm, Inline Grip

Olympus Corporation of the Americas

LYFO-DISK, Quality control kit for culture media, sold as: LYFO-DISK Enterococcus faecalis derived from ATCC 51299

Microbiologics Inc

COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells

Beckman Coulter, Inc.

Orascoptic Superior Visualization Custom loupes configured with Phantom Frames

Orascoptic Surgical Acuity

DeRoyal HEART PACK, REF 89-8351.11

DeRoyal Industries Inc

Novafil Monofilament Polybutester Suture Product Description: 8886 4002-41 NOVAFIL 3-0 BLU 90CM C14 8886 4400-13 NOV

Covidien, LP

nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90-300-251008: nanOss 3D Adva

XTANT Medical Holdings, Inc

AlluraXper FD20 Biplane OR Table System Code: (1) 722020 (2) 722025

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

ICD-VR DVAB1D1 VISIA AF US IS1/DF1, Model Number DVAB1D1; Implantable Cardioverter Defibrillators

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

BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P, REF: 169-99 containing software version 3.9.1.9

CareFusion 303, Inc.

Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0908

Howmedica Osteonics Corp.

Medline procedural kits labeled as: 1) SR C SECTION, Pack Number DYNJ908584; 2) SR C SECTION, Pack Number DYNJ908584A

MEDLINE INDUSTRIES, LP - Northfield

Centurion Kits, trays, and packs labeled as follows: a) DIALYSIS ACCESSORY PACK W/O CATHETER, REF MNS10750A; b) D

MEDLINE INDUSTRIES, LP - Northfield

GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: a) 2110344-008; b) 2110344-009;

GE Healthcare

Prime TC-transport chair intended for medical purposes to assist a person in performing an activity that the person wou

Stryker Medical Division of Stryker Corporation

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

Zimmer, Inc.

Cope Mandril Wire Guide (Nitinol), Nitinol Guidewire; Reference Part Number/GPN: PMG-18SP-60-COPE-NT-ST G09395 PMG-18

Cook Incorporated

SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass. Including the following components: a

Cardiac Assist, Inc

directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2

Accriva Diagnostics, Inc.

Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-P-6S-MCL-HC--Intended for percutaneous drai

Cook Incorporated

GE SIGNA UHP, Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

BD Pyxis MedStation ES (Med ES Main) REF: 323. Intended to securely store and dispense medications to a qualified and

CareFusion 303, Inc.

20/30 Priority Pack Accessory Kit/.096 RHV - REF 1000186 WPL2122270-01 (2019-03-01) 20/30 Priority Pack w/.115 RHV -

Abbott Vascular