Medical Device Recalls

TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600

MICROVENTION INC.

Puritan Bennett 980 Series Ventilator,980X1ENAIQC

Covidien Llc

Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora Series is intended to illuminate the

DKK Dai-Ichi Shomei Co., Ltd.

STRADIS HEALTHCARE, PROBE COVER W/GEL PACK, Item No.525-071, general surgery tray

Stradis Medical, LLC dba Stradis Healthcare

General Pack, REF BBGP31C

American Contract Systems, Inc.

Product Desc: Product Name: CLEARCUT SATINSLIT FULL HANDLE2.75MM AN Model/Catalog Number: 8065992745 Software Version:

Alcon Research LLC

Soltive SuperPulsed Laser System Wireless Footswitch, Model TFL-AFSWL

Olympus Corporation of the Americas

Atellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN:

Siemens Healthcare Diagnostics, Inc.

GENOSYL DS (Delivery System) console, for use as a vasodilator.

Vero Biotech, LLC

Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation

Medtronic Xomed, Inc.

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS V FLANG

Smiths Medical ASD Inc.

Conductivity Standard Solution Catalog/Model Numbers: 10001, 10011, 10021, 10032, 10040, 10040c, and 10041 Conducti

NIPRO Technical Services, Inc.

Silver-Plated Copper Sims Uterine Sound, Part Number 64-600

CooperSurgical, Inc.

Spectrum Medical Quantum Standard heat exchanger

QURA S.R.L.

Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2) Sensis Vibe Hemo Model 11007641

Siemens Medical Solutions USA, Inc

Initiation 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-IB00180018;

DAYE (ANNE'S DAY LTD)

Multi Joystick R-net. Electrical wheelchair component.

mo-Vis BVBA

BD Phoenix M50 Automated Microbiology System Version or Model: 443624 Catalog Number: 443624

Becton Dickinson & Co.

RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/RayPlan 10B. Radiation Therapy Treatme

RAYSEARCH LABORATORIES AB

USTAR II Knee System Cemented curved stem, RHS, Non Coated for the following reference numbers: REF: PE25153109 - 9x1

United Orthopedic Corporation

3M Attest Steam Chemical Integrators, REF 1243A

3M Company - Health Care Business

GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER, REF #2108729-901, Product Code SS9; ApexPro CARESCAPE Telemet

GE Medical Systems Information Technologies Inc

Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728

Philips North America Llc

SOFT-VU KUMPE 5F X 65CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732701

Angiodynamics, Inc.

Discovery MR750w 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to DV26.5, DV29.1, MR30.0, MR30.

GE Medical Systems, LLC

TFNA Femoral Nail 11mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractu

Synthes (USA) Products LLC

Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without Disposable Tip

Stryker Corporation

Dreamtome RX Cannulating Sphincterotome-DREAMTOME 44-20MM/260CM Material Number: M00584040

Boston Scientific Corporation

Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number: VAC-60

Clinical Innovations, LLC

Medline Convenience kits labeled as: PARACERVICAL PUDENDAL BLOCK TR, Pack Number DYNJRA1023

MEDLINE INDUSTRIES, LP - Northfield