Medical Device Recalls

BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE, Item # 856204008. Devices are packaged in a vacuum sealed

Biomet, Inc.

Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Luer Intubated Ad

Oridion Medical 1987 Ltd.

GE Healthcare Revolution Ascend Elite, Model Number 6967000-100; X-ray/computed tomography system

GE Healthcare (China) Co., Ltd.

DEX Ophthalmic Tissue Forceps, 25ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-25

Katalyst Surgical, LLC

Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the anterior wall of the stomach to

Cook Incorporated

DigitalDiagnost C90 High Performance, used to acquire, process, store, display and export digital radiographic images.

Philips North America Llc

FLIXENE, 4-7X30, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft

Atrium Medical Corporation

Puritan Bennett 980 Series Ventilator, 980A3ENNISB

Covidien Llc

Flower Lag Screw Kit 2.7 mm-intended to be used with 2.7mm lag screws and can be used with any plate that as part of the

Flower Orthopedics Corporation

MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1

Mobius Imaging, LLC

Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to create, via

Clinician's Choice Dental Products Inc.

Puritan Bennett 980 Series Ventilator, 980X1ENDIPC

Covidien Llc

Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w

AURIS HEALTH INC

Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Desc

Baxter Healthcare Corporation

Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 73-1811). Intended for use to insert an Umb

Cardinal Health 200, LLC

Medline Convenience Kits: 1) ROBOTIC GYN CDS-1, Model Number: CDS982893I; 2) GYN LAPAROSCOPY CDS, Model Number: CDS98

Medline Industries, LP

BrightView, Gamma Camera System, Product Code 882480.

Philips North America

BD BURETTE GRAVITY SET 60 DROP 2 Smartsite VALVES VENTED/NONVENTED, REF: 42163E

CAREFUSION

RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component

Ossur H / F

VentStar Basic (P)250, MP00352

Draeger Medical, Inc.

Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet, REF CDC-35552-VPS; Catheter: Percut

ARROW INTERNATIONAL Inc.

GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed

GE Medical Systems, LLC

Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-0

Datascope Corp.

epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version Number: 4.14.9. Intended for use by train

Siemens Healthcare Diagnostics, Inc.

WALLFLEX ESOPHAGEAL FC 18/23-25MMX12CM-- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System

Boston Scientific Corporation

STRADIS HEALTHCARE, Angio Pack, Item No.686-199,

Stradis Medical, LLC dba Stradis Healthcare

Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400

Abbott Medical

CRT-D DTBA1D4 VIVA XT IS1/DF4 US, Model Number DTBA1D4; Implantable Cardioverter Defibrillators

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

Extended Tip Applicator, 15 CM, Box of 5.

Integra LifeSciences Corp. (NeuroSciences)

ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US

Ethicon, LLC