Medical Device Recalls

Nasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 and Forte Catalog Number 5400-020-008ITL

Stryker Corporation

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PACK ENDO AAA HYBRID CHRG, Model

MEDLINE INDUSTRIES, LP - Northfield

Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400

Abbott Medical

MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System

BioMerieux SA

Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.

Medtronic Neuromodulation

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE PROBE W/EYE CS/50, Model Number 94-5923; 2) ECONO

Sklar Instruments

MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph

GE Medical Systems China Co., Ltd.

ICD-DR DDMB2D4 EVERA MRI XT IS-1/DF4 INT, Model Number DDMB2D4; Implantable Cardioverter Defibrillators

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

Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25

Vortex Surgical Inc.

LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Versio

Boston Scientific Corporation

GE Healthcare MR superconducting magnets, a component of GE SIGNA Excite 1.5T MR System, GE SIGNA Excite 3.0T MR System,

GE Healthcare, LLC

McKesson Cardiology Hemo software

A L I Technologies Ltd

regard MINOR NEURO, NU00140AD, Item Number 880135030; neuro surgery convenience kit

ROi CPS LLC

Brand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL PLATE, ELEGANCE 2 LEVEL CERVICAL

Clariance-SAS

DeRoyal SPINE PACK, REF 89-8361.09

DeRoyal Industries Inc

HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002

Access Vascular, Inc

Product Desc: Product Name: A-OK SATINSLIT FULL HANDLE2.75MM ANG SG Model/Catalog Number: 8065992761 Software Version:

Alcon Research LLC

Catalys Precision Laser System, Models: Catalys-U (United States), Catalys-I (International), Catalys-C (China); and Cat

AMO Manufacturing USA, LLC

Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing, Model/Ca

Zimmer, Inc.

Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P

Medline Industries, LP

Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4721

Hobbs Medical, Inc.

Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-term neurological monitoring system that colle

Moberg Research, Inc.

VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198

Ortho-Clinical Diagnostics, Inc

mC12-3 Transducer Probe

Philips Ultrasound, Inc

CareFusion V.Mueller GENESIS SMALL CONTAINER 21 X 7" (53.3 X 17.8CM) 5-1/2" (14CM) DEEP STERRAD COMPATIBLE, REF CD4-5ST

Carefusion 2200 Inc

SIGNA MR355, SIGNA MR360, NMRI system

GE Healthcare (China) Co., Ltd.

INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model: SC-2317-70,

Boston Scientific Neuromodulation Corporation

GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200. Anesthesia system.

GE Medical Systems China Co., Ltd.

EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only

Covidien, LLC

SURG PAT XRAY 1/4X1/4 Model/Catalog Number: 801399. The surgical patties and surgical strips are indicated for the use

Integra LifeSciences Corp.