Medical Device Recalls

Medline Kits, trays, and packs labeled as follows: a) LACERATION KIT, REF SUT13935; b) LACERATION TRAY, REF SUT2121

MEDLINE INDUSTRIES, LP - Northfield

LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-228

Howmedica Osteonics Corp.

DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative,

Beckman Coulter, Inc.

STERILE PVP, REF DYNDA1649

MEDLINE INDUSTRIES, LP - Northfield

Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780040

TELEFLEX LLC

ADVANTA VXT, 4-7X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft

Atrium Medical Corporation

Lunderquist -Ring Torque Wire Guide, Guidewire Reference Part Number/GPN THSF-35-125-THG G27031 THSF-35-145-THG G2703

Cook Incorporated

Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0

Smiths Medical ASD Inc.

Arrow Temporary Pacing Catheter/Introducer Kit 5Fr. pacing catheter 6 Fr. introducer Product Code: AI-07155-IK - Produ

Arrow International Inc

Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument

Beckman Coulter, Inc.

Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-135; Color Cuff Dual Port,

Stryker Sustainability Solutions

The Synchro Neuro Guidewires are a steerable guidewire family with a shapeable tip. The outside diameter of the Synchro

Stryker Neurovascular

Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: MHR 110-b Software Version: 1.5.0.0 Produc

LEASEIR TECHNOLOGIES SLU

VITEK 2 REAGENT AST-XN15 TEST KIT 20 CARDS, CATALOG 423829

Biomerieux Inc

SOLTIVE Premium SuperPulsed Laser (TFL-PLS )

Olympus Corporation of the Americas

Allura Xper FD20/15 OR Table; Model Numbers: 722059; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979,

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC

Karl Storz Endoscopy

GE Healthcare Revolution Maxima M, Model Number, 6670000-2; X-ray/computed tomography system

GE Healthcare (China) Co., Ltd.

NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-151. The NES Reprocessed Tur

Northeast Scientific Inc.

GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100

DePuy Orthopaedics, Inc.

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001713;

Beaver Visitec International, Inc.

Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0320; Software

Olympus Corporation of the Americas

Ziehm Vision system, x-ray, tomography, computed.

Orthoscan, Inc.

Medline procedure packs containing Shenli syringes, labeled as follows: 1) LOCAL PACK, pack number DYNJ34129C, 2)

MEDLINE INDUSTRIES, LP - Northfield

Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 3L Catalog Number: FG 12022. Intended adjunc

Stryker Corporation

Atellica CH Urine Albumin (UAlb). Material Number: 11537225

Siemens Healthcare Diagnostics, Inc.

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.

Olympus Corporation of the Americas

Laser light show projectors manufactured by BLS, Model DIODE 1000/2000/3000.

Beyond Laser Systems, LLC

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: AN01 CAROTID ANESTH K

Medline Industries, LP

Ventlab, LLC V-Care manual resuscitators with integrated manometer, multiple accessory configurations to include: 1.

SunMed Holdings, LLC