Medical Device Recalls

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Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE-FJ. For mapping of the heart

Abbott

ICD-VR DVMB2D1 EVERA MRI XT OUS DF1, Model Number DVMB2D1; Implantable Cardioverter Defibrillators

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

DeRoyal BIOPSY PACK, REF 89-9614.07

DeRoyal Industries Inc

MEDLINE convenience kits labeled as: 1) MAMMOPLASTY-LF, REF CDS983478L; 2) MAMMOPLASTY-LF, REF CDS983478M; 3) PLASTI

MEDLINE INDUSTRIES, LP - Northfield

Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator

Medtronic Neuromodulation

HENRY SCHEIN, ENT PACK, Item No.570-2718

Stradis Medical, LLC dba Stradis Healthcare

Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

Datascope Corp.

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. KIT NEURO CSTM SAMP0551

Medline Industries, LP

Omnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle; Manufactured by Eco-Med. For use in ultra

Accelerated Care Plus Corporation

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

Philips North America Llc

Medline custom medical procedure kits labeled as: 1) ENDOSCOPIC SKULL BASE, REF DYNJ58648B; 2) ENDOSCOPIC SKULL BAS

MEDLINE INDUSTRIES, LP - Northfield

BF-P60 OES Bronchofiberscope, Model No. BF-P60

Olympus Corporation of the Americas

4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1360

Busse Hospital Disposables, Inc.

Infusomat UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE-Used with an electrically-powered infusion pump for intravenous (IV) a

B. Braun Medical, Inc.

Canon Aplio ultrasound system, Model: Aplio i900 TUS-AI900, Aplio i800 TUS-AI800, Aplio i700 TUS-AI700, Aplio a550 CUS-A

Canon Medical System, USA, INC.

Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System; Electrocardiograph

Baxter Healthcare Corporation

GEO-MED LOWER EXTERMITY PACK, REF 89-8252.02

DeRoyal Industries Inc

AXIOM MULTIX MP - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO

Siemens Medical Solutions USA, Inc

Nidek Co. Disposable Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: 18241-0979. Product Description: The Dis

Kirwan Surgical Products, LLC

Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.

Boston Scientific Corporation

Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit)

Percussionaire Corporation

Allura Xper FD10; Model Number: 722010;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

HENRY SCHEIN, Breast Augmentation tray, Item No.570-0611

Stradis Medical, LLC dba Stradis Healthcare

Medline IV TEAM PICC, REF DYNJ48222; medical procedure convenience kit

MEDLINE INDUSTRIES, LP - Northfield

DeRoyal BIOPSY PACK, REF 89-9739.06

DeRoyal Industries Inc

DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.

Philips North America Llc

Medtronic Sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation

Medtronic Xomed, Inc.

McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only

Covidien

Ingenia Elition S -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra

Philips North America Llc