Medical Device Recalls

Jackson-Pratt 3-Spring Reservoir with Silicone Adapters, 400mL, REF SU130-475

Cardinal Health 200, LLC

Model Number U226, VISIONIST CRT-P EL

Boston Scientific Corporation

SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000

Siemens Medical Solutions USA, Inc

STRADIS HEALTHCARE, Phlebectomy Pack, Item No.682-001,

Stradis Medical, LLC dba Stradis Healthcare

Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100

Olympus Corporation of the Americas

Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A

Medline Industries, LP

iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616

Atrium Medical Corporation

OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02

Exactech, Inc.

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VAD/PICC IV KIT, Model Numbe

MEDLINE INDUSTRIES, LP - Northfield

PPM CLINICAL CRAPONNE CLINICAL CHROMID CANDIDA 20 PLATES, CATALOG 43631

Biomerieux Inc

Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component:

Draeger Medical, Inc.

Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.

OSSTEM Implant Co., Ltd.

TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005

Acclarent, Inc.

Medline Convenience kits used for various procedures: 1) MINOR BASIN -SMH, Model Number: DYNJ907733B

MEDLINE INDUSTRIES, LP - Northfield

BD Phoenix PMIC/ID-107: The Phoenix PMIC/ID panel is used for the rapid identification and susceptibility of most aerob

Becton Dickinson & Co.

UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.

Uromedica Inc.

BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System Epicenter F/G, Catalog

Becton Dickinson & Co.

MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.

Siemens Medical Solutions USA, Inc

Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU: NX-3532K-SC Orthopedic surgical instrum

Nextremity Solutions

Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain

Abbott Molecular, Inc.

DeRoyal CRANI PACK, REF 89-10202.05

DeRoyal Industries Inc

Computed Tomography X-ray System, Model: uCT ATLAS with software

Shanghai United Imaging Healthcare Co., Ltd.

LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 45MM Item Number: 15-2028/03

Linkbio Corp.

CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.

American Contract Systems Inc

SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900C CLINICIAN TABLET UK with

Medtronic Neuromodulation

AnchorFast, Oral Endotracheal Tube Fastener, REF 9799,

Hollister Incorporated

Tracheostomy care kits: (1) Medline Tracheostomy Clean and Care Tray with 14 Fr Suction Catheter, REF DYND40580, Ster

MEDLINE INDUSTRIES, LP - Northfield

Olympus BRONCHOVIDEOSCOPE, Model Numbers BF-Q170

Olympus Corporation of the Americas

Medtronic Grafton Matrix: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF S42200; b) DBM S42210 GRAFTON 2.5CMX5CM 2

Medtronic Sofamor Danek USA Inc

Model Number 40KWFXPLUS-710CW.007, Mobile X-ray system

SEDECAL SA