Medical Device Recalls

REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130

Encore Medical, LP

Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. CARDIAC CATH PACK

AVID Medical, Inc.

GE Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

Burlington Medical, Half Aprons.

Burlington Medical, LLC

Medline convenience kits containing semi-rigid suction liners labeled as follows: MERCY TIFFIN C-SECTION, Pack Number D

MEDLINE INDUSTRIES, LP - Northfield

Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog

Olympus Corporation of the Americas

PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701

VANTIVE US HEALTHCARE LLC

Brand Name: GMAX Product Name: SYR 10ML/LL syringe Model/Catalog Number: TS2210L-M Product Description: NON-Sterile s

Jiangsu Shenli Medical Production Co., Ltd.

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001546;

Beaver Visitec International, Inc.

Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated, Compatible with FT10 Generator 44cm FT10 SW Version 4.0.1.

Medline Industries, LP

MEDLINE convenience kits labeled as: 1) BURN, REF CDS983465M; 2) BURN, REF CDS983465N; 3) BURN PACK, REF DYNJ63331

MEDLINE INDUSTRIES, LP - Northfield

DeRoyal BASIC NEURO PACK, REF 89-7258.10

DeRoyal Industries Inc

Hobbs Helical Retrieval Basket Catalog Number: 4832

Hobbs Medical, Inc.

Penner Pacific Bathing Spa, Model Numbers 360020-1EP

Penner Patient Care, Inc.

ISee Ortho-K Lens

PARAGON VISION SCIENCES, Inc

Intera 1.5T Achieva Nova-Dual, Magnetic Resonance System.

Philips North America Llc

TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798

Tobii Dynavox Llc

Ziehm Vision RFD. Interventional fluoroscopic x-ray system

Orthoscan, Inc.

Centurion procedure packs, containing Caina syringes, labeled as: 1) BREAST BIOPSY KIT, Pack Number DYNDH1512A; 2)

MEDLINE INDUSTRIES, LP - Northfield

CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web

St. Jude Medical

Octopus Evolution AS Tissue Stabilizer, Model TS2500

Medtronic Perfusion Systems

Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alternate name: ECTR (End

MicroAire Surgical Instruments, LLC

EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilat

Olympus Corporation of the Americas

Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,2PRT QUICK Catalog number: 5921-030-235NS

Stryker Corporation

BVI Leos Laser and Endoscopy System. Model Number: OME6000U.

Beaver-Visitec International, Inc.

OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, prim

NeuroLogica Corporation

Infusomat UNIV. 15 DROP PUMP SET, 2 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV)

B. Braun Medical, Inc.

Halyard CYSTO PDS - Medical convenience kits Model Number: GVVA002-05

AVID Medical, Inc.

Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis

Coloplast Manufacturing US, LLC

ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues.

Smith & Nephew Inc.