Medical Device Recalls

Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.

Olympus Corporation of the Americas

Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1

Covidien

Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Number: 119695-000, 119629-000, 119630-000,

IMRIS Imaging Inc

Signature Laparoscopic Instruments, Sharp Tooth Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Con

Silex Medical, LLC

Ingenia 1.5T Evoluton- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The syste

Philips North America Llc

Monosof Monofilament Nylon sutures: Product Description CN-724 MONOSOF* 1 BLK 100CM GS25 X36 CN-791 MONOSO

Covidien, LP

Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105

Philips North America

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000426;

Beaver Visitec International, Inc.

Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY, SKU DYNJ35349C

MEDLINE INDUSTRIES, LP - Northfield

Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT;

Covidien, LP

MAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter, Sterile, Single Use, Rx Only: 13.5cm, Straight Extensi

Covidien LP

Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can

Philips North America Llc

DeRoyal CATARACT PACK, REF 89-8859.08

DeRoyal Industries Inc

Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interfaces with CardioMEMS" H

St. Jude Medical

GE Healthcare Revolution EVO, Model Number 5454001-260; X-ray/computed tomography system

GE Healthcare (China) Co., Ltd.

Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z

Maquet Cardiovascular, LLC

GE SIGNA Voyager AIR (China Only), Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

epoc NXS Host; Siemens Material Number (SMN): 11413506 (CA); Software Version Number: 4.14.9. Intended for use by tra

Siemens Healthcare Diagnostics, Inc.

Medline Convenience Kits: 1) PICC CATHETER INSERTION TRAY, Model Number: CVI4300; 2) OSC SHERMAN KNEE ARTHRO BASIC, M

Medline Industries, LP

CRTD CROME HF MRI IS1 DF1, Model Number DTPC2D1; Implantable Cardioverter Defibrillators

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

CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11

Centers For Disease Control and Prevention

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Num

Smiths Medical ASD Inc.

OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 11111

Philips Respironics, Inc.

GE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169767, M1160674, M1187512, M1206646, M1166822

Wipro GE Healthcare Private Ltd.

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST US; the system utilizes an int

Boston Scientific Corporation

Zoll, REF: 8700-0783-03 (IC-4593AE) QUATTRO Intravascular Heat Exchange Catheter Kit, with central venous infusion capab

ZOLL Circulation, Inc.

HENRY SCHEIN, Knee Pack, Item No.570-2908,

Stradis Medical, LLC dba Stradis Healthcare

Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEX

International Life Sciences

Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 099

Datascope Corp.

OPTETRAK Comprehensive Knee System custom devices labeled as the following: a. CUSTOM OPTETRAK ANGLED PS INSERT (Pro

Exactech, Inc.