Medical Device Recalls

Sterile surgical convenience kits: 1. regard Item Number: 880353009, GS00797I - Laparotomy Pk; 2. regard Item Number

ROi CPS LLC

Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only

Merete Medical GmbH

VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922

Ortho-Clinical Diagnostics, Inc

Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Number: CI-5501-110; CI-5

Advanced Bionics, LLC

Small Joint OATS Set, REF AR-8981-06S, 6mm; and Small Joint OATS Set, REF AR-8981-08S, 8mm, both containing a cannulated

Arthrex, Inc.

FIXODENT ORG CREAM 2.4OZ, SKU 906018 FIXODENT ORG CREAM TRAVEL .75OZ, SKU 901239

Family Dollar Stores, Llc.

Philips Azurion 7M20, Model Numbers: 722079, 722224 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 wit

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model Number: 728240. 2. Brilliance CT 16 Sl

Philips North America Llc

Surgical convenience kits labeled as: MEDLINE PAIN TRAY, Reorder Number DYNJRA1122A

MEDLINE INDUSTRIES, LP - Northfield

ETEST CLINICAL TOBRAMYCIN TM 256 US S30, CATALOG 412478

Biomerieux Inc

ProCurity bed series, model number 3009, item number: 3009PX-ZX-450.

Stryker Medical Division of Stryker Corporation

IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100. The needles are intended to convert high-pressure

Boston Scientific Corporation

Olympus POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0537CJDA. An electrosurgi

Olympus Corporation of the Americas

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002042;

Beaver Visitec International, Inc.

GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5; Part Number 5867474-04; M

Wipro GE Healthcare Private Ltd.

bvi CustomEyes Kit-CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as a componen

Beaver Visitec International, Inc.

Hobbs Helical Retrieval Basket Catalog Number: 4816

Hobbs Medical, Inc.

WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedic device.

Wishbone Medical, Inc.

Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4

Intuitive Surgical, Inc.

EasyDiagnost Eleva DRF, Release 5, used to acquire, process, store, display and export digital radiographic images.

Philips North America Llc

CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 4" (10CM) DEEP STERRAD COMPATIBLE, REF CD2-4ST

Carefusion 2200 Inc

Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080

Biomet, Inc.

smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery.

Smith & Nephew Orthopaedics Ltd. (Aurora)

Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip

Olympus Corporation of the Americas

Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) KIT UROLOGY URETHROPLASTY, Model Nu

Medline Industries, LP

MAHURKAR Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.

Mozarc Medical US LLC

FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)

BioFire Diagnostics, LLC

Intera Achieva 1.5T Pulsar, Magnetic Resonance System.

Philips North America Llc

Pentax Medical Video Processor; Model Number: EPK-i8020c;

Pentax of America Inc