Medical Device Recalls

Initiation 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-IBAIO;

DAYE (ANNE'S DAY LTD)

MEDLINE Medical Procedure Kits labeled as: 1) KIT UROLOGY URETHROPLASTY, Medline Kit Number/SKU DYKMBNDL117C; 2) UR

Medline Industries, LP

JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis

Smith & Nephew, Inc.

FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0

Foundation Medicine, Inc.

SIGNA MR360, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR systems with SW version R11.1 and R12.1.

Philips North America

Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN916548), cardiac pump

ARROW INTERNATIONAL Inc.

ADVANTA VXT, 6X50, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft

Atrium Medical Corporation

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

B Braun Medical Inc

BASIC IMPLANT PACK, Item No. 40310SBI, oral surgery tray

Stradis Medical, LLC dba Stradis Healthcare

UA KIT, SKU DYKM1690A; Component No. 503581

MEDLINE INDUSTRIES, LP - Northfield

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K12

Merit Medical Systems, Inc.

ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code 68-2230-28

Smiths Medical ASD Inc.

Medline Kits: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB; 2) MANIFOLD KIT LOW PRESSURE OFF, Model N

Medline Industries, LP

Medline Kits: 1) GENERAL LAPAROSCOPY, Model Number: CDS930027Y

Medline Industries, LP

Abiomed Oscor Introducer Kit, 14Fr x Long Individual (0052-0017)- Introducer(s) are intended for introduction of the Imp

Abiomed, Inc.

Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect

Abiomed, Inc.

BD PhaSealTM Y-Site Connector (C80)- airtight and leak-proof Closed System Drug Transfer Device (CSTD) that mechanically

Becton Dickinson & Company

CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Stryker Sustainability Solutions

QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3-E, Order Number G22667; used to dilate strictures of the biliary tree

Wilson-Cook Medical Inc.

Ref No: INS7250 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brai

Integra LifeSciences Corp.

ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/Che

ICU Medical, Inc.

Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers

Olympus Corporation of the Americas

ICD-VR DVFB1D4 VISIA MRI AF US DF4, Model Number DVFB1D4; Implantable Cardioverter Defibrillators

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

4.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1362

Busse Hospital Disposables, Inc.

Sofsilk Coated Braided Silk Suture Product Description CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 CS211 CS-490 SO

Covidien, LP

Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM8, iM8A, iM8B Product Description: iM8 Series

Edan Diagnostics

Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A

Canon Medical System, USA, INC.

Maquet Volista, Volista Access, Volista Access II, Volista Standop OR Light System, Model Numbers and Catalog Numbers RO

Getinge Usa Sales Inc

Icelock 125 Ratchet, REF: L-125000; Icelock 600XM Ratchet, REF: L-621200; Icelock 621 Ratchet, REF: L-621000; Icelock

Ossur H / F