Medical Device Recalls

MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20

Mozarc Medical US LLC

Catalog A119216M, SureStep" Foley Tray, Lubri-Sil", Urine Meter, Temperature Sensing Dual, StatLock" Stabilization Devic

C.R. Bard Inc

Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code: (01)008

Philips Medical Systems (Cleveland) Inc

RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200

Randox Laboratories Ltd.

TOTAL KNEE - 247546 Procedure tray Catalog Number: BFTK01Z

American Contract Systems Inc

Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500NL (IPN000326), cardiac pump

ARROW INTERNATIONAL Inc.

BritePro Solo Mini with Pro Miller Blade Size 1.5, REF:040-02-0415U

Flexicare Medical (Dongguan) Ltd.

Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter

Datascope Corporation

Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the endoscope.

Aomori Olympus Co., Ltd.

LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-028

Howmedica Osteonics Corp.

eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3, eCareManager version 4.5.1, eCareMan

Philips North America Llc

Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010

Aesculap Implant Systems LLC

DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere,

Alcon Research LLC

LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK C

Physio-Control, Inc.

MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, IC Tray REF: 8888101003H

Covidien LP

Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat

B Braun Medical Inc

Cardiosave Hybrid Model Nos. 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-35 099

Datascope Corp.

GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004

Instrumentation Laboratory

Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151

Siemens Healthcare Diagnostics, Inc.

CoolFit ZELTIQ Vacuum Applicator REF BRZ-AP1-066-000

Zeltiq Aesthetics, Inc

ProxiDiagnost N90 R.1.0

Philips North America

WALLFLEX PC ESOPH STENT 23/28MM X 125MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intende

Boston Scientific Corporation

Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382030

TELEFLEX LLC

MEDLINE beds labeled as: Full Electric Low Basic Homecare Bed, REF MDR107003ELO

Medline Industries, LP

Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR LAPAROTOMY CDS, Model Number: C

Medline Industries, LP

VITEK 2 REAGENT AST-GN81 TEST KIT 20 CARDS, CATALOG 413438

Biomerieux Inc

Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PUSH OTW Model/Catal

Avanos Medical, Inc.

NOA Medical Industries Behavioral Health Hospital bed side rails, Product number 1055050GRY-BOX

NOA Medical Industries Inc

Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461

Agilent Technologies Denmark ApS

NeuroSync EYE-SYNC containing Pico Neo 2 Headsets. Each unit consists of a Pico Neo 2 headset with embedded sensors, a p

NeuroSync, Inc.