Medical Device Recalls

Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the

DKK Dai-Ichi Shomei Co., Ltd.

Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300. Product Description: The CycloPen Microinter

Iantrek Inc.

Vesmatic Cube 80 Interface Module (VMC)-Laboratory Automation system Brand names of the same product: FlexLab (FLX),

Inpeco S.A.

Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal ne

Cook Inc.

FLIXENE, 6X30, 1GDS, STR. Single-Ended Slider GDS. Vascular graft

Atrium Medical Corporation

Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.

Fresenius Kabi USA, LLC

ADVANTA VXT, 8X40, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft

Atrium Medical Corporation

TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia Tracking Array REF 109004 UDI-DI code: M

Think Surgical, Inc.

Medline Syringes: 1) SYRINGE 12ML CONTROL W/ROTATOR, Model Number: DYNJSYR12CWR; 2) SYRINGE 10ML CONTROL W/ROTATOR, M

Medline Industries, LP

QIAcube Connect MDx, Model No. 9003070

Qiagen Sciences LLC

Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 780 MD, Rx Only

UIH Technologies LLC

Stimuplex A, 30 DEG, 21GX4", 0.80x100mm, Catalogue Number: 4894260

B Braun Medical Inc

Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Whee

Max Mobility LLC

smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee j

Smith & Nephew Inc

ADVIA Centaur CA 19-9 (250 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated

Siemens Healthcare Diagnostics, Inc.

Guider Softip Guide Catheter 8F PRE-SHAPED 40 100CM, Catalog number M003101440, cardiac guide catheter

Boston Scientific Corporation

Brand Name: GMAX Product Name: SYR 20ML/LL syringe Model/Catalog Number: TS2220L-M Product Description: NON-Sterile s

Jiangsu Shenli Medical Production Co., Ltd.

Artis zee ceiling, Model Number 10094137

Siemens Medical Solutions USA, Inc

regard ACDF, NU00698I, Item Number 800246009; neuro surgery convenience kit

ROi CPS LLC

Centricity Universal Viewer 6.0. Used to display medical images (Including mammograms) and data from various imagin

GE Medical Systems, LLC

RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X11001 (01)00860003983812(11)230518(21)X11002

Reflexion Medical, Inc.

Medline medical procedure kits labeled as follows: a) KIT CANISTER SUCT W 12FT, REF DYKM2169

MEDLINE INDUSTRIES, LP - Northfield

Model No. BF-P190, EVIS EXERA III Bronchovideoscope

Shirakawa Olympus Co., Ltd.

NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540

CooperSurgical, Inc.

Model Number 40KWFXPLUS.002, Mobile X-ray system

SEDECAL SA

EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile.

Boston Scientific Corporation

ICD-DR DDMC3D4 EVERA MRI S IS-1/DF4 GLOB, Model Number DDMC3D4; Implantable Cardioverter Defibrillators

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118

ICU Medical, Inc.

Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkins

Medtronic Neuromodulation

Baxter Operating Table TruSystem 7000 (dV), Product code REF 1841049

Baxter Healthcare Corporation