Medical Device Recalls

Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an

Olympus Corporation of the Americas

Medline custom medical procedure kits labeled as: 1) CATH LAB PACK-LF, REF DYNJ0382559M; 2) CRANI, REF DYNJ56001B;

MEDLINE INDUSTRIES, LP - Northfield

CRE Pro Wireguided 15-18mm 240cm

Boston Scientific Corporation

Dexcom One+ Continuous Glucose Monitoring System, SKU(Part Number): STK-D7-013 (MT28285-1), STK-D7-014 (MT28285-1), STK-

Dexcom, Inc.

Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MINI 4HM/169-113, BD PYXIS MEDBANK MINI 4HH

CareFusion 303, Inc.

Ingenia 1.5T (Product Number 781396) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system

Philips North America

Burlington Medical, Kilt Blockers.

Burlington Medical, LLC

Hill-Rom Progressa Bed System

Baxter Healthcare Corporation

Insufflation unit, UHI-4.

Olympus Corporation of the Americas

Getinge Flow-c Anesthesia System, Part No. 6887700

Getinge Usa Sales Inc

smiths medical portex BLUselect, tracheostomy tube, labeled as follows: 1) BLUSELECT 6.0, CUFFED, NON-FEN, 10/BX, Item

Smiths Medical ASD Inc.

GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;

W.L. Gore & Associates, Inc.

HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU

Medtronic Inc

epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Version Number: 4.14.9. Intended for use by t

Siemens Healthcare Diagnostics, Inc.

BD Pyxis MedStation ES 7 Drawer Auxiliary Tower, REF: 324

CareFusion 303, Inc.

NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 55, REF E NRT-06055-I The NutraGlide Nasal Feeding Tub

Applied Medical Technology Inc

MEDLINE convenience kits labeled as: 1) TOT/ GYN LITHOTOMY CDS, REF CDS985431J; 2) TOT/ GYN LITHOTOMY CDS, REF CDS9

MEDLINE INDUSTRIES, LP - Northfield

Brand Name: MEDLINE Product Name: SYR 1ML TB Model/Catalog Number: 83089 Product Description: NON-Sterile syringes wi

Jiangsu Shenli Medical Production Co., Ltd.

Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile

Biosense Webster, Inc.

Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BT

Covidien, LP

Visera Hysterovideoscope Olympus HYF Type V

Olympus Corporation of the Americas

COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are int

Covidien LLC

CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND0930

INSPIREMD Inc

Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067,

Philips North America Llc

Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle REF:040-03-0000U

Flexicare Medical (Dongguan) Ltd.

Brand Name: MEDIGRATIVE Product Name: 100cc/ml disposable luer lock syringe Model/Catalog Number: 10025 Product Descr

Jiangsu Shenli Medical Production Co., Ltd.

DeRoyal BIOPSY PACKPACK, REF 89-9756.05

DeRoyal Industries Inc

Multichem ID-B. Model Number: SR103B. Intended for use as an unassayed positive qualitative quality control serum to

TECHNO-PATH MANUFACTURING LTD.

Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System PIM cable part number 459801179871

Philips North America

Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Reference Part Number/GPN PMG-18SP-60-COPE G05183

Cook Incorporated