Medical Device Recalls

Allwell Inflation Device, for angiographic use REF: IS-30-A

Merit Medical Systems, Inc.

MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202P; 2) BASIC NEURO PACK, REF CDS780202Q; 3)

MEDLINE INDUSTRIES, LP - Northfield

Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number:DYNJ56436A; 2) SCC RF PAIN MGMT, Model Number:DYNJ56436B;

Medline Industries, LP

WALLFLEX ESOPHAGEAL FC 23/28MMX12CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended fo

Boston Scientific Corporation

Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fi

Cook Biotech, Inc.

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

Medline Arthroscopy Kit, convenience kit, REF DYNJ904304B, containing expired component NaCl 3000mL Irrigation Bag (exp

Medline Industries Inc

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

SIN SISTEMA DE IMPLANTE NACIONAL S.A

Infusomat Space Volumetric Pump Administration Set, Product Code 490100

B. Braun Medical, Inc.

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