Medical Device Recalls

RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12.3.0. Software Version: RayStation 11B, R

RAYSEARCH LABORATORIES AB

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001999;

Beaver Visitec International, Inc.

Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical s

Paltop Advanced Dental Solutions Ltd

HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH

Heartware, Inc.

S7-3t Transducer Probe

Philips Ultrasound, Inc

Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 750830

MEDLINE INDUSTRIES, LP - Northfield

AirTouch F20 Full Face Mask and User Guide

ResMed Ltd.

CardioMEMS HF System Hospital Electronics System (HES), Model number CM3000, The CardioMEMS HF System provides pulmonary

St. Jude Medical

ICU Medical ChemoLock Port REF: CL2100

ICU Medical, Inc.

Halyard ENDOVASCULAR - Medical convenience kits Model Number: VMED008-02

AVID Medical, Inc.

BD BACTEC FX, Instrument Top, Packaged Version or Model: 441385 Catalog Number: 441385

Becton Dickinson & Co.

Freeman Pancreatic Flexi-Stent (contained in kit 6501) Catalog Number: 6541

Hobbs Medical, Inc.

CARESCAPE B650: Model Numbers: a) MBB313, Model Numbers: 1) 2095801-001, 2) 2095801-001-01018416, 3) 2095801-001-

GE Healthcare Finland Oy

DIEP FLAP Convenience kit, SKU DYNJ910120. Convenience kits used for various procedures.

MEDLINE INDUSTRIES, LP - Northfield

Brand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04B / 68020033 Software Vers

Dentsply IH, Inc.

Immundiagnostik IDK Lactoferrin ELISA- In vitro enzyme immunoassay intended for the determination of lactoferrin in stoo

IMMUNDIAGNOSTIK, Inc

Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealth Autoguide Basic Instrument Kit, Mode: 973

Medtronic Navigation, Inc.

MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm

Mozarc Medical US LLC

Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038

ESAOTE S.P.A.

Azurion 3 M12; Catalog numbers: (1) 722063, (2) 722221.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Medline procedural kits labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT6715; 2) NICU CIRCUMCISION TRAY W/OUT CLAMP

MEDLINE INDUSTRIES, LP - Northfield

ACS Lap Chole Pack

American Contract Systems, Inc.

JAGTOME REVOLUTION RX 39-30-260-025 Material Number: M00584260

Boston Scientific Corporation

T-Cell Xtend REF TTK.610 US

OXFORD IMMUNOTEC LTD

1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combinati

NRT X-RAY A/S

3M SYSTAGENIX/KCI KerraCel Ag DRESSING, WOUND KERRACEL AG 4X5 (10/CT 10CT/CS) Catalog #CWL1158

Mckesson Medical-Surgical Inc. Corporate Office

Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthropl

Stryker Orthopaedics

Destino Twist 14F (also branded as Guidestar 14F)

Oscor Inc.

ICU Medical Oncology Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock" Port, ChemoLock" Bag Spike, Ext Set w/Chem

ICU Medical, Inc.

Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1 BLA,1PRT QUICK Catalog number: 5921-218-135

Stryker Corporation