Medical Device Recalls

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

Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 60 MM Item Number: 11-301311

Biomet, Inc.

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

AMO Manufacturing USA, LLC

A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting

Philips Respironics, Inc.

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.

Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (including mammograms

GE Healthcare, LLC

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.

Injection Needle, LUER-lock,0.8mm, REF: 26175PD

Karl Storz Endoscopy

HUDSON RCI mBrace, ET Tube Holder with Bite Block and 2 Point Head Strap, REF DYNJMBRC2B; tracheal tube fixation device

MEDLINE INDUSTRIES, LP - Northfield

AGILE ESO OTW PC 23MM X 15.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent Syste

Boston Scientific Corporation