Medical Device Recalls

ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material #

Siemens Medical Solutions USA, Inc

regard DAVINCI PACK, GS00137W, Item Number 880132023; gastric surgery convenience kit

ROi CPS LLC

eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152

Civco Medical Instruments Co. Inc.

QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to dilate strictures of the biliary tree

Wilson-Cook Medical Inc.

Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.5MM TIP, Catalog Number 6760-230-015

Stryker Corporation

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001503;

Beaver Visitec International, Inc.

FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring System

Abbott Diabetes Care, Inc.

Microstream Instructions for Use and Part Number used with - Product Description, REF: Filter Line Sets Adult/Pediat

Oridion Medical 1987 Ltd.

SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L; Untreated, Blue Markings Model/Catalog Number: 06 0508 Product

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K1

Siemens Medical Solutions USA, Inc

MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL

Avanos Medical, Inc.

GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 3.0T MR System, nuclear magnetic resonance

GE Healthcare, LLC

Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic

Siemens Healthcare Diagnostics, Inc.

1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"

Argon Medical Devices, Inc

Puritan Bennett 980 Series Ventilator, 980U1ESDIUC

Covidien Llc

UNIVERSAL CORE DR RUNNELS PACK. Sterile Procedural Tray

MEDLINE INDUSTRIES, LP - Northfield

MEDLINE LUER SLIP DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101020

MEDLINE INDUSTRIES, LP - Northfield

ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the f

DePuy Orthopaedics, Inc.

Medline medical procedure convenience kits labeled as: 1) WATKINS SPINE PACK-LF, Kit SKU DYNJ0275635M; 2) SM-SPINE

Medline Industries, LP

Surgilon Braided Nylon suture Product Description: 88861883-51 SURGILON* 2-0 BLK 75CM C16 88861915-71 SURGILON* 1 BLK

Covidien, LP

Sterile Procedural Trays, labeled as the following: AMBULATORY MINI PACK

MEDLINE INDUSTRIES, LP - Northfield

Elscint SPX6; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

Brand Name: Banner University Med Ctr. Product Name: Cardiac Cath Lab Pack-170278 Model/Catalog Number: GSCC40G Sof

American Contract Systems, Inc.

Brand Name: GMAX Product Name: SYR 35ML/LL syringe Model/Catalog Number: TS2235L-M Product Description: NON-Sterile s

Jiangsu Shenli Medical Production Co., Ltd.

Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15

GE Medical Systems, LLC

McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only

Covidien

PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-411

Howmedica Osteonics Corp.

see RES for description

MEDLINE INDUSTRIES, LP - Northfield

Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm, Front-

Olympus Corporation of the Americas

Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722)

Medtronic MiniMed, Inc.