Medical Device Recalls

DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06

DeRoyal Industries Inc

MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280

Beckman Coulter, Inc.

Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa

B Braun Medical Inc

MEDLINE ADLT BLOOD CLUTURE COLLECT KIT, Reorder #: DYNDH1245

MEDLINE INDUSTRIES, LP - Northfield

WALLFLEX ESOPHAGEAL FC 18/23-25MMX15CM- Agile Esophageal Partially Covered and Fully Covered OTW Stent System is intende

Boston Scientific Corporation

Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N

SIN SISTEMA DE IMPLANTE NACIONAL S.A

Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028, LABEL, STERILE, IVSTATION SYRING

Omnicell, Inc.

ADVANTA VXT, 7X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft

Atrium Medical Corporation

Compella Therapy Air Supply Unit

Baxter Healthcare Corporation

Impella RP with SmartAssist. Product Code: 0046-0035.

Abiomed, Inc.

Alinity ci-series System Control Module, REF: 03R70-01

Abbott Laboratories

GM Helix Acqua Implant 3.5x10, Article No. 140.944

Jjgc Industria E Comercio De Materials Dentarios Sa

COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1

Covidien, LLC

IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions

Ion Beam Applications S.A.

Allura Xper FD20/15 OR Table; System Code: 722059;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

TECNIS Eyhance IOLs are permanent intraocular implants intended for implantation in the capsular bag. The TECNIS Simpli

Johnson & Johnson Surgical Vision Inc

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001764;

Beaver Visitec International, Inc.

13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal arthrodesis

Synthes (USA) Products LLC

Various convenience packs

American Contract Systems, Inc.

Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each

Nihon Kohden America Inc

eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159

Civco Medical Instruments Co. Inc.

GEO-MED PLASTIC HAND PACK RF, REF 89-6667.09

DeRoyal Industries Inc

ETEST CLINICAL ETEST MEROPENEM/VABORBACTAM MEV US S30, CATALOG 421560

Biomerieux Inc

ABBOTT POINT OF CARE TEST CREA I-STAT (25/BX) ABBTPT CARTRIDGE.

Mckesson Medical-Surgical Inc. Corporate Office

Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems

Steris Corporation

Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm Model/Catalog Number: 506-04-1

Encore Medical, LP

i-STAT CG4+ cartridge (white). List Number: 03P85-25.

Abbott Point Of Care Inc.

Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foi

Biomet, Inc.

Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU).

Boston Scientific Corporation

Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Progressa Bed, Product Code/Part Number P0

Baxter Healthcare Corporation