Medical Device Recalls

Guider Softip Guide Catheter 5F PRE-SHAPED 40 90CM, Catalog number M003100620, cardiac guide catheter

Boston Scientific Corporation

SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #7 -Intended for knee replacement Part Number: 73-2710

Howmedica Osteonics Corp.

The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.

DIXI MEDICAL USA

Robotics Pack, REF SJVO56B

American Contract Systems, Inc.

Medline Convenience kits labeled as: 1) CENTRAL LINE CDS, Pack Number CDS930092U ; 2) SMALL WOUND TRAY, Pack Number D

MEDLINE INDUSTRIES, LP - Northfield

Halyard PACEMAKER PK - Medical convenience kits Model Number: WKMC120-02

AVID Medical, Inc.

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH GXL 0 DEGREE LINER 28MM

Exactech, Inc.

Configura Advance Chair, Model Number: CHAIR-0-SC1-030; Advance Chair, 100mm Castors, Std Backrest, Manual; Serial Numbe

Accora Inc

Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517;

New Medical Technologies Gmbh

MEDLINE procedure kits labeled as follows: 1) CONT EPI 20G W/HUSTEAD, REF PAIN1069B; 2) CSE TRAY, REF PAIN1941; 3) T

MEDLINE INDUSTRIES, LP - Northfield

Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.

Fresenius Kabi USA, LLC

Raz-AT (Attendant Tilt) Mobile Shower Commode Chair, Catalog Number Z300 UDI-DI code: (01)00628758003007 Raz-ART (At

Raz Design Inc

DigitalDiagnost C90 Release 3, used to acquire, process, store, display and export digital radiographic images.

Philips North America Llc

Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber 21 Gauge REF OPOHF21L The ir

Johnson & Johnson Surgical Vision, Inc.

Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta V

ELEKTA SOLUTIONS AB

AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.

SonarMed Inc

Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85

Datascope Corp.

Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee MP 1009

Siemens Medical Solutions USA, Inc

Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK

Beckman Coulter Inc.

BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143

BioFire Diagnostics, LLC

ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during

Aesculap Implant Systems LLC

HUDSON RCI mBrace, ET Tube Holder with 4 Point Head Strap, REF DYNJMBRC4; tracheal tube fixation device

MEDLINE INDUSTRIES, LP - Northfield

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001579;

Beaver Visitec International, Inc.

Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitative determination of cardiac t

Beckman Coulter, Inc.

Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit Model/Catalog Number: IMU7F-40, IMU7F-35, IM

Insightra Medical Inc

Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Inte

NRT X-RAY A/S

Mammotome MammoStar Biopsy Site Identified, REF STAR1401

Carbon Medical Technologies, Inc.

QMS Tacrolimus Calibrators, Product code 10015573

Ortho-Clinical Diagnostics, Inc.

8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179

Intuitive Surgical, Inc.

REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a Honeywell Vuquest

Cellavision AB