Medical Device Recalls

Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T15

Aizu Olympus Co., Ltd.

NexxZr T Multi A3.5 W98-16mm, REF: 745451

Sagemax Bioceramics, Inc.

ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref: (1)706100 (2)706110

Philips North America

Hookup Model/Catalog Number: 2-8-540HAN Product Description: Hookups provide the interface between an Advantage Plus

Steris Corporation

Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with shortn

Olympus Corporation of the Americas

STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values.

Stanbio Laboratory, LP

FoundationOne Companion Diagnostic (F1CDx)

Foundation Medicine, Inc.

Philips L12-3 Transducer.

Philips Ultrasound, Inc

Product Name: Allura Xper FD10C; Model number: 722001;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

stay-safe /Luer Catheter Ext. 6 in

Fresenius Medical Care Holdings, Inc.

TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-000

Cardiac Assist, Inc

WALLFLEX FC ESO STENT RMV 23X155MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Inten

Boston Scientific Corporation

STRADIS HEALTHCARE, Basic Implant Pack, Item No.40561BIP, oral surgery tray

Stradis Medical, LLC dba Stradis Healthcare

Medline Convenience kits labeled as: 1) OR CLEAN UP KIT, Pack Number DYK1002355X3, 2) CLEANING & CUTTING, Pack Numb

MEDLINE INDUSTRIES, LP - Northfield

Ingenia 1.5T CX, Magnetic Resonance System.

Philips North America Llc

Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEM. Part Number: 150450205.

DEPUY (IRELAND)

regard CERVICAL PACK, NU00303H, Item Number 800058008; neuro surgery convenience kit

ROi CPS LLC

GE Healthcare Discovery NM/CT 670 CZT, Model/Catalog Numbers: 1) H3906AB; System, Tomography, Computed, Emission

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applicatio

Olympus Corporation of the Americas

CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 5" (12.7CM) DEEP STERRAD COMPATIBLE, REF CD3-

Carefusion 2200 Inc

8MM,RESANO FORCEPS,IS4000 ¿ REF 470181

Intuitive Surgical, Inc.

Ref No: HITHSP04 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the bra

Integra LifeSciences Corp.

SurgiMend 3.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25

TEI Biosciences, Inc.

AGILE ESO FC RMV 23MM X 6.2CM IN 18.5 FR-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent Syste

Boston Scientific Corporation

Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative determination of LDL cholesterol in human ser

Siemens Healthcare Diagnostics, Inc.

Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.

Fresenius Medical Care Renal Therapies Group, LLC

Philips X6-1 Transducer.

Philips Ultrasound, Inc

SmartPath to dStream for 1.5T, Model Number: 782146;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11

THERANICA BIOELECTRONICS LTD

BD PYXIS MEDBANK MINI CR-2HH-1FH-P, REF: 169-114 containing software version 3.9.1.9

CareFusion 303, Inc.