Medical Device Recalls

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ANGIO KIT PACK DYNJ50783B

Medline Industries, LP

Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,1PRT QUICK Catalog number: 5921-030-135NS

Stryker Corporation

Spectral CT; Product Code (REF): 728333;

Philips North America Llc

HAMILTON-C6, REF: 160021

Hamilton Medical AG

Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for i

Fresenius Kabi USA, LLC

Burlington Medical, Leg Wraps.

Burlington Medical, LLC

Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS)

Stryker Corporation

Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.

Hologic, Inc.

Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P

Becton, Dickinson and Company

MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075V; 2) C-SECTION OR 30 CDS, REF CDS820075W;

MEDLINE INDUSTRIES, LP - Northfield

Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08

Cook Incorporated

Various Angiography packs/trays

American Contract Systems, Inc.

Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and pl

Beckman Coulter Inc.

DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-10240.03

DeRoyal Industries Inc

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ROBOTIC HYSTERECTOMY, Medlin

Medline Industries, LP

A.L.P.S. mvX-MEDIAL TIBIA PLATE 10H RT-Medial Tibia Plate, 10-Hole, Right Intended Fixation of fractures of the distal

Tyber Medical

Centurion procedure kits labeled as: 1) 3" RADIAL ARTERIAL LINE KIT- ICU, Pack Number ART240B; 2) 5FR 2L PICC LINE TR

MEDLINE INDUSTRIES, LP - Northfield

VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box.

Ortho-Clinical Diagnostics, Inc.

Thermalon Stye Compress, Item Number 24352

Bruder Healthcare Company, LLC

Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-A

Olympus Corporation of the Americas

Ingenia Ambition S Model Number (REF): (1) 782139; (2) 782133; (3) 782108; (4) 781359

Philips North America Llc

SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3710

Howmedica Osteonics Corp.

CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, 0.5MM TIP, ANGLED-UP FINE OVERALL LENGTH 8-3/4" (225MM), REF F-5

Carefusion 2200 Inc

Intelli-C, Left side suspended Tabletop, REF: 03400010

NRT X-RAY A/S

Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot

Beckman Coulter Mishima K.K.

SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.

ConvaTec, Inc

Medtronic Custom Perfusion kits, with the following product descriptions and corresponding model numbers: 1. CUSTOM

Medtronic Perfusion Systems

Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition Box) Model/

Natus Neurology DBA Excel Tech., Ltd. (XLTEK)

Alinity i Anti-TPO Reagent Kit, List Number 09P3521

Abbott Ireland Limited

Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm

Medtronic Sofamor Danek USA Inc