Medical Device Recalls

Azurion 7 M20 System code: (1) 722224 (2) 722079 (3) 722234 (4) 722282 System Code: (1) 722078 (2) 722223

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Catalog A800361, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray

C.R. Bard Inc

SS 3.2MM Pellet Insertion Tray Catalog Number: B8110R1

Busse Hospital Disposables, Inc.

MEDLINE beds labeled as: Full Electric Low Lightweight Homecare Bed, REF MDR107003LO

Medline Industries, LP

Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Gauge, containing 6 inne

Elekta Instrument AB

Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598B

Cordis Corporation

DHEA Test

GET TESTED INTERNATIONAL AB

Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S11, UDSX500S11F, UDSX700S11, UDSX700S11F, U

Philips Respironics, Inc.

CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782

Cytocell Ltd.

EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 and BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 Model

Olympus Corporation of the Americas

Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83, 0998-UC-08

Datascope Corp.

Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009

Exactech, Inc.

Product Name: 25+ CMB PAK 10K CPM,V,STD 0.9 Model/Catalog Number: 8065752450 Software Version: N/A Component: N/A

Alcon Research LLC

LEFT X-LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-328

Howmedica Osteonics Corp.

CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enumeration of circulating tumor cells (CTC) of

Menarini Silicon Biosystems

Always-On Tip Tracked Instruments (SPiN Drive instruments) 21ga ANSO Cytology Needle, 12mm L, 1.8mm OD-Intended for use

Olympus Corporation of the Americas

VITEK 2 REAGENT BCL TEST KIT VTK2 20 CARDS, CATALOG 21345

Biomerieux Inc

Elscint SPX4; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

LIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021

Physio-Control, Inc.

McKesson Calcium Alginate Dressing MFR# 3562 Wound dressing indicated for moderate to heavily exuding chronic and acu

Advanced Medical Solutions Ltd.

Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L Model/Cata

Olympus Corporation of the Americas

BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111145 1111147 1111148 11

Philips Respironics, Inc.

In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147

BioFire Diagnostics, LLC

SIGNA Voyager nuclear magnetic resonance imaging system

GE Healthcare, LLC

SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144;

Philips North America

CardioMEMS HF System Patient Electronics System (PES), Model number CM1010, The CardioMEMS HF System provides pulmonary

St. Jude Medical

FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W

BioFire Diagnostics, LLC

ICD-VR DVEX3E4 EV ICD EV4 PIVOTAL, Model Number DVEX3E4; Implantable Cardioverter Defibrillators

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

Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model

Dexcom, Inc.

3M Attest Super Rapid Readout Steam Challenge Pack, REF 1496V; designed to qualify and monitor dynamic-air removal steam

3M Company - Health Care Business