Medical Device Recalls

Centurion Kits, trays, and packs labeled as follows: a) BASIC PROCEDURE TRAY, REF MNS13600; b) BWH DAILY DRIVELINE

MEDLINE INDUSTRIES, LP - Northfield

Beckman Coulter Bicarbonate, REF: OSR6237, 4x50 mL

Beckman Coulter Inc.

CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic examination/treatment of urina

Calyxo, Inc.

Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis

Coloplast Manufacturing US, LLC

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: CHN OR DAVINCI PROSTATE, Model

MEDLINE INDUSTRIES, LP - Northfield

WATCHMAN TruSeal Access System ANT, OUS, Material Number (UPN) M635TS70040; intended to provide vascular and transseptal

Boston Scientific Corporation

A610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.x (2.0.4584, 2.0.4594

Medtronic Neuromodulation

Model No. ENF-XP, RHINO-LARYNGOFIBERSCOPE

Shirakawa Olympus Co., Ltd.

Allura Xper FD10C System Code: (1) 722001

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM

Howmedica Osteonics Corp.

Medline procedure kits labeled as: 1) SHORT TERM INFUSAPORT ACCESS KIT, Reorder number DYNDC3188; surgery tray

MEDLINE INDUSTRIES, LP - Northfield

Medex 700PSI STOPCOCK W/ROTATOR, List Number MX4331R

Smiths Medical Asd Inc

Ki Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU The Little Wave Tyke is a manually operated

Ki Mobility Llc

DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemo

Angiodynamics, Inc.

CRTD CROME HF QUAD MRI IS4 DF4, Model Number DTPC2QQ; Implantable Cardioverter Defibrillators

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

NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems with either of the following assays: Ne

NeuMoDx Molecular Inc

ID Coax 180, MP03375

Draeger Medical, Inc.

Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06

Intuitive Surgical, Inc.

CLARITI 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker

CooperVision Inc.

Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone reconstruction limited to inter-digital rep

Nextremity Solutions

QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3-E, Order Number G22765; used to dilate strictures of the biliary tree

Wilson-Cook Medical Inc.

Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation

Elekta Inc

Spectral CT on Rails: Software Version 5.1.0.X, model 728334.

PHILIPS MEDICAL SYSTEMS

Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007

Remote Diagnostic Technologies Ltd.

EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x

BERLIN HEART GMBH

Puritan Bennett 980 Series Ventilator, 980U3ESDIUU

Covidien Llc

Orthex Large Bone Shoulder Bolt, model no. AS-17

OrthoPediatrics Corp

AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a sut

Aesculap Implant Systems LLC

BD Pyxis MedStation ES Tower REF: 352 Medication cabinet

CareFusion 303, Inc.

Brand Name: Dako CoverStainer, Dako CoverStainer CPO Product Name: CoverStainer, CoverStainer CPO Model/Catalog Number

Agilent Technologies