Medical Device Recalls

VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6844458

Ortho-Clinical Diagnostics, Inc.

Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apical Coring Knife, REF: 1050

Thoratec Corp.

DeRoyal LAMINECTOMY PACK, REF 89-10209.02

DeRoyal Industries Inc

SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS

Olympus Corporation of the Americas

Trilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B

Philips Respironics, Inc.

VIDAS Clostridium Difficile GDH, REF 30125-01

bioMerieux, Inc.

JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis

Smith & Nephew, Inc.

BD Pyxis MedStation 4000 REF: 303 Medication cabinet

CareFusion 303, Inc.

Medline convenience kits containing semi-rigid suction liners labeled as follows: a) LAMINECTOMY CDS, Pack Number CDS98

MEDLINE INDUSTRIES, LP - Northfield

Edwards PediaSat Oximetry Catheter Kit, REF: XT3515SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of

Edwards Lifesciences, LLC

MiniMed 770G Insulin Pump (U.S. and O.U.S. Version)

Medtronic MiniMed

Maquet XTen OR Light Systems, Model Numbers and Catalog Numbers 3001 HMD14 - ARD567732001C, X TEN DUO - ARD568221510C, X

Getinge Usa Sales Inc

(1) Centurion Sterile CirClamp, Reorder #200CR; (2) Centurion CirClamp with 1.1cm Bell and Insert, Reorder #210CR, Ster

MEDLINE INDUSTRIES, LP - Northfield

DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20

Beckman Coulter, Inc.

HealthyWiser pH-Aware pH 4.5 - 9.0 pH Test Strips REF 900-1P 120 STRIP

Universal Meditech Inc.

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) SILVER CROSS OPEN HEART, Model

MEDLINE INDUSTRIES, LP - Northfield

SX-One MicroKnife

SONEX HEALTH LLC

Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71 Product Description: Rover Mobile

Micro-X Ltd.

Incisive CT Power- Whole-body computed tomography (CT) X-Ray System Model Number: 728148 (OUS)

PHILIPS HEADQUARTERS CAMBRIDGE

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. VP SHUNT, Medline Kit Number

Medline Industries, LP

a. DYNAREX WeCare PETROLATUM JELLY, WHT 5GM (144/BX 6BX/CS) DYNREX Catalog #1140. b. DYNAREX Dynarex PETROLEUM JELLY,

Mckesson Medical-Surgical Inc. Corporate Office

Aspiration Syringe Kit, REF: MVSK60

MICROVENTION INC.

Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2226

Cardinal Health 200, LLC

Otological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2;

Adept Medical Ltd

MedMinder Medication Dispenser- Intended to serve as a medication reminder to promote medication adherence with addition

Medminder Systems, Inc.

Medline medical convenience kits packaged as: SUTURE REMOVAL TRAY, Kit SKU DYNDR1277A

Medline Industries, LP

Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3s, iM3As, iM3Bs, iHM3s Product Descriptio

Edan Diagnostics

Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges Model/Catalog Number: 235447 Software Vers

Fujirebio Diagnostics, Inc.

MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;

Globus Medical, Inc.

LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126¿, Offset= 31 mm,

Waldemar Link GmbH & Co. KG (Mfg Site)