Medical Device Recalls

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

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.

Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm - Designed for general electrosurgical appli

Stryker Corporation

Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated

Oridion Medical 1987 Ltd.

Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.

Philips North America

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001944;

Beaver Visitec International, Inc.

Medline procedure kits labeled as: 1) AV FISTULA PACK-LF, Pack Number DYNJ0826753O; 2) BARRINGTON ACCESSORY TTL KNE

MEDLINE INDUSTRIES, LP - Northfield

Model Number L211 PROPONENT DR SL MRI Pacemaker

Boston Scientific Corporation

ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgica

Materialise N.V.

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis

Baxter Healthcare Corporation

CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 8" (20.3CM) DEEP STERRAD COMPATIBLE, REF CD2-8S

Carefusion 2200 Inc

Refill 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-REFAIO;

DAYE (ANNE'S DAY LTD)