Medical Device Recalls

Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/

Olympus Corporation of the Americas

Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum

Princeton Biomeditech Corp

ECONO STERILE medical procedure kits labeled as: ECONO STERILE KOGAN ENDOCERV SPEC STER CS/5, Model Number 96-4142A,

Sklar Instruments

Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological mapping of cardiac structures. Medline Item Numbe

Medline Industries, LP

SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented

Waldemar Link GmbH & Co. KG (Mfg Site)

eL18-4 Transducer Probe

Philips Ultrasound, Inc

BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150, BF-1T60, BF-P150 BF-P60 and EVIS EXERA BRONCHOVIDEOSCOPE OLYM

Olympus Corporation of the Americas

BD Synapsys Informatics Solution (Laboratory Solution) Version or Model: 444150 Catalog Number: 444150

Becton Dickinson & Co.

28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028

Howmedica Osteonics Corp.

Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with re

Isopure Corp

BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in conjunctio

BioFire Diagnostics, LLC

VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart. Product ID VXW0002 Devic

Boston Scientific Corporation

ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)

Siemens Healthcare Diagnostics, Inc.

Model Number 40KW-FX.899, Mobile X-ray system

SEDECAL SA

Millenium MG/MC; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

Intera 1.5T Explorer/Nova Dual, Magnetic Resonance System.

Philips North America Llc

RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000

Randox Laboratories Ltd.

Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral device

Pentax of America Inc

DeRoyal PACEMAKER ICD PACK, REF 89-10902.01

DeRoyal Industries Inc

Halyard CPT CARDIAC CATH PACK - Medical convenience kits Model Number: SHAN430-02

AVID Medical, Inc.

8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump System

B. Braun Medical, Inc.

Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 165cm Disposable For endoscopy procedures Ref: 2191

Hobbs Medical, Inc.

Olympus Airway Mobilescope, Models MAF-DM2, MAF-GM2, & MAF-TM2.

Olympus Corporation of the Americas

BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.

BioFire Diagnostics, LLC

CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU

Beckman Coulter, Inc.

Carefusion V. Mueller GERALD BIPOLAR FORCEPS 1.0MM WIDE TIP OVERALL LENGTH 7" (17.8CM) , REF F-1110

Carefusion 2200 Inc

Hobbs Posi-Stop Injection Needle Catalog Number: 4702

Hobbs Medical, Inc.

Abbott Proclaim 7 Implantable Pulse Generator, REF 3667, Sterile EO, Rx Only

Abbott Medical

UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis

Beckman Coulter, Inc.

SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold as accessories for th

Philips Respironics, Inc.