Medical Device Recalls

GE Healthcare Innova IGS 6, Interventional fluoroscopic x-ray systems

GE Medical Systems, SCS

Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Combined Procedure Pak Model/Catalog Nu

Alcon Research LLC

Trilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Evo, O2, Benelux EV300; BR2200X18B Trilogy E

Philips Respironics, Inc.

HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Explore Tech, c) Monit

Heartware, Inc.

IntelliSystem Inflation Device, REF: IN1525/D

Merit Medical Systems, Inc.

ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722)

Boston Scientific Corporation

100V NEPTUNE 3 ROVER JAPANESE (0703-003-000) 120V NEPTUNE S ROVER (0711-001-000) 230V NEPTUNE 3 ROVER ENGLISH (0703-00

Stryker Corporation

Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080085

TELEFLEX LLC

Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000325), cardiac pump

ARROW INTERNATIONAL Inc.

GEM Premier 5000 PAK; Part No. 00055360010.

Instrumentation Laboratory

DeRoyal GU ROBOTIC PACK, REF 89-7063.12

DeRoyal Industries Inc

a. McKesson DISINFECTANT, GLUTARALDEHYDE 28DAY (4GL/CS) MGM68, Model Number: 68-102800. b. METREX RESEARCH McKesso

Mckesson Medical-Surgical Inc. Corporate Office

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VISCERAL ANGIOGRAM PACK-LF,

MEDLINE INDUSTRIES, LP - Northfield

Medline Convenience Kits: 1) KIT UROLOGY SLING, Model Number: DYKMBNDL106; 2) KIT UROLOGY SLING, Model Number: DYKMBN

Medline Industries, LP

Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight. Model/Catalog Number: 14-5011 The Disposab

Kirwan Surgical Products, LLC

Single Shot Epidural Tray - 18G Catalog Number: 8139R2

Busse Hospital Disposables, Inc.

CareFusion V.Mueller GENESIS LARGE, SHALLOW CONT. 28 X 11" (71.1 X 27.9CM) 3" (7.6CM) DEEP, PERFORATED STERRAD COMPATIBL

Carefusion 2200 Inc

Sit to Stand STS500 Patient Lift

Med-Mizer, Inc.

MEDLINE Medical Procedure Kits labeled as: 1) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775I; 2) RETINA LAC/

Medline Industries, LP

Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C.

Olympus Corporation of the Americas

Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (24cm)), Code No. T5C4482

Baxter Healthcare Corporation

ALLURA Xper FD10 OR Table; System Code: (1) 722022, (2)722033;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

GE Healthcare Discovery NM 630, Model/Catalog Numbers: 1) 5376204-30-2, 2) H2401CF, 3) H2401CH, 4) H2401JE, 5

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

CareFusion V. Mueller Neuro/Spine TITANIUM BAYONET INSULATED IRRIGATING BIPOLAR FORCEPS 0.5MM TIP, ANGLED-UP, FINE OVERA

Carefusion 2200 Inc

Optiflux¿ High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFL

Fresenius Medical Care Holdings, Inc.

Sterile Procedural Trays, labeled as the following: a. SPINAL b. SPINE CDS c. TOTAL ORTHO CDS d. TOTAL KNEE CDS e. CD

MEDLINE INDUSTRIES, LP - Northfield

GEO-MED PODIATRY PACK PGYBK, REF 89-8700.01

DeRoyal Industries Inc

Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen

Cardinal Health 200, LLC

Colonoscope, Model Number PCF-H190TL.

Olympus Corporation of the Americas

FlexoStretch Model Number: 3156057 - The combination of this products allows the user to easily adjust/control the cente

Hill-Rom, Inc.