Medical Device Recalls

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

B Braun Medical Inc

Achieva 1.5T Conversion, Magnetic Resonance System.

Philips North America Llc

Cardinal Health Jackson-Pratt Channel Drain, 28 Fr, REF JP-2290

Cardinal Health 200, LLC

Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341.

Philips North America

Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K1

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

BrightView XCT, Gamma Camera, Product Code 882482

Philips North America

Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-Ray Systems

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Coons Interventional Wire Guide, Guidewire; Reference Part Number/GPN: THSF-35-145-COONS G02356 THSF-38-145-COONS G02

Cook Incorporated

DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED REF 243-01-108 DJO

Encore Medical, LP

Infusomat UNIV. 15 DROP PUMP SET W 3 CARESITE L.L. Used with an electrically-powered infusion pump for intravenous (IV

B. Braun Medical, Inc.

MEDLINE Medical Procedure Kits labeled as: 1) D AND C PACK, Medline Kit Number/SKU DYNJ53973C; 2) PK CUST CV A&B CA

Medline Industries, LP

C-Rex UNO Microinterventional Goniotomy Instrument. Model Number: CRX-120. Product Description: The C-Rex UNO Microi

Iantrek Inc.

CareFusion V. Mueller TITANIUM BAYONET INSULATED IRRIGATING BIPOLAR FORCEPS 1.5MM TIP, STRAIGHT, INSULATED OVERALL LENGT

Carefusion 2200 Inc

Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72813

Philips North America

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (5PK), REF H74908526032; cardiac catheter

Boston Scientific Corporation

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 155 (5PKX3), REF H749085263022; cardiac catheter

Boston Scientific Corporation

DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central monitoring system. Model: RGD

Philips North America Llc

iLED 7 surgical lights, Model Numbers: a) 4068110 (Ceiling Single Surgical Light); b) 4068120 (Mobile Surgical Ligh

Baxter Healthcare Corporation

A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..

Medtronic Neuromodulation

CRT-D DTBB1D4 VIVA S IS1/DF4 US, Model Number DTBB1D4; Implantable Cardioverter Defibrillators

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

Discovery MR750 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to DV26.4, DV29.1, MR30.0, MR30.1

GE Medical Systems, LLC

Brand Name: GMAX Product Name: SYR 12ML/LS syringe Model/Catalog Number: TS2212S-M Product Description: NON-Sterile s

Jiangsu Shenli Medical Production Co., Ltd.

Applied Medical Technology, Inc., NutraGlide, 5 F- 6 F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-05055-N-I

Applied Medical Technology Inc

25-LHP-828, HeNe Laser System, 35 mW

PACIFIC LASERTECH, LLC

VACUETTE SAFELINK, REF: 450210

Greiner Bio-One GmbH

BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P, REF: 169-91 containing software version 3.9.1.9

CareFusion 303, Inc.

Medline brand, medical procedure convenience kits, labeled as: 1) MVFF/FIBU #54-RF , SKU DYNJ21927R; 2) DIEP FLAP, SKU

MEDLINE INDUSTRIES, LP - Northfield

MIC* Gastric-Jejunal Feeding Tube, Endoscopic/Radiologic Placement, GJ-Tube: a) MIC* Gastric-Jejunal Feeding Tube Kit -

Avanos Medical, Inc.

Medline convenience kits: ADD-A-CATH ARTERIAL INSERTION ARTNC185 PED SCHOOL AGE PICC DRSG TRAY DYNDC3291

Medline Industries, LP

HeartWare HVAD Pump Implant Kit, REF 1103

Heartware, Inc.