Medical Device Recalls

GEO-MED OPTHALMOLOGY CSTM PCK, REF 89-6387.08

DeRoyal Industries Inc

Medline medical procedure convenience kits labeled as: 1) PACER / CATH LAB PACK-LF, Kit SKU DYNJ0972604A; 2) PACEMA

Medline Industries, LP

Augmedics Perc Pin Adaptor, Model/Catalog Number AMCH07200, a component of the xvision Spine (XVS) system, an image-guid

Augmedics Ltd.

Description/REF: PACING PSI KIT: 6 FR/AI-06210-KS, PACING PSI KIT: 5 FR 2-L/AI-07155-KS, PACING PSI KIT: 5 FR 2L/ASK-

ARROW INTERNATIONAL, LLC

Model Number U125, VALITUDE CRT-P EL

Boston Scientific Corporation

EAR PACK , Model No SFEA12A

American Contract Systems Inc

CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic ba

Datascope Corp.

FlowGate2 8F x 85cm, Catalog: 90485 FlowGate2 8F x 95cm, Catalog: 90495

Stryker Neurovascular

URINE KIT W/BD CUP, SKU DYLAB1001A; Component No. 503581

MEDLINE INDUSTRIES, LP - Northfield

Chemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contains 5 cartridges of 60 slides, for a total o

Ortho-Clinical Diagnostics, Inc.

Impella 2.5 intravascular micro axial blood pump, Product Number 005042

Abiomed, Inc.

Fusion Pro 24, Model 17000

Epilog Laser Corp.

Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.

Accuray Incorporated

Medline Convenience Kits: 1) TRUNK KIT W/EXPIRATION, Model Number: DYKM1361A; 2) TRUNK KIT 1EA, Model Number: DYKM201

Medline Industries, LP

Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the followin

SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION

Sterile Water/Saline: Product Name/Product Code: CUP STERILE WATER¿ FOIL LID 120 ML/T167005; CUP STERILE SALINE FOIL LID

Nurse Assist, LLC

Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number: 5955460

Davol, Inc.

Daig Livewire Steerable, Product Number 401923; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Stryker Sustainability Solutions

Tec 820 SEV Anesthesia Vaporizer, Reference Number 1177-9820-SEV

GE Medical Systems, LLC

Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-

Exactech, Inc.

Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;

Waldemar Link GmbH & Co. KG (Mfg Site)

ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S

ICU Medical, Inc.

Cobalt Implantable Cardioverter Defibrillators: a. Cobalt VR ICD, Model Numbers: DVPB3D1, DVPB3D4; b. Cobalt DR ICD, Mod

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

Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with SW version R11.1 and R12.1.

Philips North America

TenderNeeds Fertility PRO IUI Human Artificial Home Insemination Kits, SKU 133166055771

Tenderneeds Fertility LLC

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0725 Product Description: These ins

Olympus Corporation of the Americas

FLIXENE, 6X50, 1GDS, GW. Single-Ended Slider GDS. Vascular graft

Atrium Medical Corporation

Pilonplate with Angular Stability, with the below descriptions and corresponding article numbers. 1. Anterolateral T

I.T.S. GmbH

BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (

Becton Dickinson & Company

Achieva 1.5T Conversion, Model No. 781283

Philips North America