Medical Device Recalls

IntelliVue Patient Monitor MX450. Product Number: 866062.

Philips North America Llc

Soft -Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 038 NB 0SH; Catalog No.: 10710013; Product/

Angiodynamics, Inc.

PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A,

Merit Medical Systems, Inc.

Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025525, spinal implant

Medtronic Sofamor Danek USA Inc

Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP

Contego Medical LLC

Philips CT systems labeled as the following: 1. Brilliance iCT SP, Model Number: 728311.

Philips North America Llc

BD Pyxis MedStation Auxiliary 4000 REF: 306. Intended to securely store and dispense medications to a qualified and aut

CareFusion 303, Inc.

Trilogy Evo, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.

Philips Respironics, Inc.

LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 23 - Indicated for patients with Mobility-limiting diseases, fr

Waldemar Link GmbH & Co. KG (Mfg Site)

3M Specialty Blade Assembly, REF 9660,70-2011-8491-1, 7100213026, used with used with 3M Surgical Clipper Catalog Number

3M Company - Health Care Business

Cardinal Health Presource Kits: 0 ) DESCRIPTION Catalog Number: CATALOG #; 1 ) KIT, NASAL , Catalog Number: PE23NSME

Cardinal Health 200, LLC

Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog Number: (1) 6802445, (2) 6900440 Software

Ortho-Clinical Diagnostics, Inc.

GaGa Pro Lighting Equipment Co. Ltd. manufactures Class IV Laser Light Show (LLS)projectors for the purposes of demonstr

GAGA PRO LIGHTING EQUIPMENT CO.,

Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK RIVERSIDE HEALTH SYSTEM Model/Catalog Number: 552126 Software Ve

B Braun Medical Inc

MR 7700 -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the in

Philips North America Llc

Beckman Coulter DxI 9000 Access Immunoassay Analyzer

Beckman Coulter, Inc.

Exactech Vantage Ankle System, Catalog Numbers: a) 350-21-04, b) 350-22-03

Exactech, Inc.

BD BBL Sensi Disc Ceftriaxone- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231634

Becton Dickinson & Co.

WATCHMAN FXD Curve Access System Sgl, US, Material Number (UPN) M635TU80010; intended to provide vascular and transsepta

Boston Scientific Corporation

Neurotransmitters XL

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syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as foll

Siemens Medical Solutions USA, Inc

Optima Coil System Model OPTI0520CSF10. For endovascular embolization.

BALT USA, LLC

Zoll, REF 8700-000872-40, SOLEX 7(Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer

ZOLL Circulation, Inc.

Compress Device Short Anchor Plug, 18 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous

Biomet, Inc.

GM Helix Acqua Implant, Article Number: 140.985

Straumann USA LLC

Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382040

TELEFLEX LLC

Medline CISION Sterile Blades. Labeled as follows with corresponding Item Number. a. STERILE BLADE NO. 10 CARBON STEEL

MEDLINE INDUSTRIES, LP - Northfield

Pentacam HR REF 70900. Used to image the anterior segment of the eye.

Oculus Optikgeraete GMBH

Centurion kits: a) DENTAL INSTRUMENT KIT, Product Code DH760; b) STERILE COTTON DENTAL ROLLS 6/PK, Product Code 9125S

MEDLINE INDUSTRIES, LP - Northfield

GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR430s System, nuclear magnetic resonance

GE Healthcare, LLC