Medical Device Recalls

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

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

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

Fresenius Kabi USA, LLC

Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780060

TELEFLEX LLC

Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ADULT BLOOD CULTURE KIT DYNDH1444D BL

Medline Industries, LP

SCORPIO RECESSED PATELLA- Intended for Knee Replacement Part Number: 3044-0026

Howmedica Osteonics Corp.

5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905

Aniara Diagnostica LLC

CT 5300; Software Version Number: 4.5, 5.0, 5.1;

Philips North America Llc

GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The Glidesheath Slender is used to

Terumo Medical Corporation

20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box

CellEra LLC

Set2Go Ventilation 12 (A), MP07968

Draeger Medical, Inc.

STERILE MAGILL FORCEP (MAGF9), Medline Item No. 66790

MEDLINE INDUSTRIES, LP - Northfield

Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA VATS 3D; CFN: BOX06

Covidien, LP

MAGELLAN DIAGNOSTICS LeadCare II Blood Lead Test Kit Rapid Test Kit LeadCare II General Chemistry Blood Lead Test Whole

Mckesson Medical-Surgical Inc. Corporate Office

Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular Catheter, STERI

Medtronic Neurosurgery

Hobbs Helical Retrieval Basket Catalog Number: 4822

Hobbs Medical, Inc.