Medical Device Recalls

Medline Convenience kits, labeled as: 1) NERVE STIMULATOR, Pack Number CDS981579O ; 2) DR DIULUS INJECTION PACK, Pack

MEDLINE INDUSTRIES, LP - Northfield

epoc NXS Host; Siemens Material Number (SMN): 11413498(JP) ; Software Version Number: 4.14.9. Intended for use by tra

Siemens Healthcare Diagnostics, Inc.

BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P, REF: 169-90 containing software version 3.9.1.9

CareFusion 303, Inc.

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0730 Product Description: These ins

Olympus Corporation of the Americas

Artis zee biplane MN, Model Number 10094143

Siemens Medical Solutions USA, Inc

Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1.5-ROSEN G01623 THSCF-35-80-1.5-ROSEN G017

Cook Incorporated

Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Produc

Intuitive Surgical, Inc.

Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis,

Covidien Llc

WALLFLEX FC ESO STENT RMV 18X103MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Inten

Boston Scientific Corporation

1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD. Magnetic Resonance Imaging System

GE Healthcare, LLC

BD Pyxis Mini Main REF: 349 Medication cabinet

CareFusion 303, Inc.

Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catalog Number: 38-2006SP FORZA Ti Spa

Orthofix U.S. LLC

TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter

Abbott

Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye.

Oculus Optikgeraete GMBH

Cardinal Health Monoject, 1 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 401SE

Cardinal Health 200, LLC

VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422

Intuitive Surgical, Inc.

HAWK Advanced Hypothermia Management Set, Item Number: 59-320

Safeguard US Operating LLC

Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)

Saranas, Inc.

Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S

Stryker Corporation

GEM Premier 5000; Part No. 00055415008.

Instrumentation Laboratory

Regard NEWBORN KIT, LD00201M, Item Number: 830016013. Medical convenience kit which includes an infant heel warmer.

ROi CPS LLC

Cardiosave Hybrid Intra-Aortic Balloon Pump. Model Numbers: D998-00-0800-31, D998-00-0800-32, D998-00-0800-33, D998-00-0

Datascope Corp.

Medline Convenience kits labeled as: 1) CVC INSERTION PACK, Pack Number CVI4720A ; 2) CVC INSERTION PACK, Pack Numb

MEDLINE INDUSTRIES, LP - Northfield

CARESCAPE Canvas Smart Display, Model Numbers: a) 5514418, b) 5514418 / MAEP2, c) 5514418-01059642, d) 5514418-01

GE Healthcare Finland Oy

Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System, REF: IS4200; Pa

Intuitive Surgical, Inc.

Centurion procedure packs, labeled as: 1) BIOPSY TRAY-LF, Pack Number SPEC4380; 2) CIRCUMCISION TRAY, Pack Number C

MEDLINE INDUSTRIES, LP - Northfield

Uric Acid in vitro diagnostic test REF: 31H0P

DFI Co., Ltd.

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

SPECSAVERS UMERE TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens with UV blocker

CooperVision Inc.

LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004

Fresenius Kabi USA, LLC