Medical Device Recalls

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

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

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

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)

Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 44" X 4" 2-LINE (CS 10) GREEN Model/Catalog Number:

ASP Global, LLC.

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

Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Descrip

SEASPINE ORTHOPEDICS CORPORATION

Cartiva Synthetic Cartilage Implant (SCI) Catalog: CAR-06-US (6mm), CAR-08-US (8mm), CAR-10-US (10mm), CAR-12-US (12mm)

Cartiva, Inc

The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming

Abbott Medical

LUMBAR PUNCTURE DRUG FREE TRAY 22G

Bard Peripheral Vascular Inc

5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1. 5008X HD Pre-Flush S

Fresenius Medical Care Holdings, Inc.

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. OPEN H

MEDLINE INDUSTRIES, LP - Northfield

MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MRT-1504 (MEXL-1504),

Canon Medical System, USA, INC.

Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system

SEDECAL SA