Medical Device Recalls

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

Computed Tomography X-ray System, Model: uCT 780 with software

Shanghai United Imaging Healthcare Co., Ltd.

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

Medline Convenience Kits: 1) ANESTHESIA KIT PEDS 90-LF, Model Number: DYNJAP10125A

Medline Industries, LP

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.

Ultrasonic Cleaning Systems Triton 36 Model Number 6003000804 Triton 72 Model Number 6003000805 Ultrasonic cleaning

Ultra Clean Systems, Inc.

Medline Convenience kits labeled as: 1) SPECIAL PROCEDURE PACK ARTERI , Pack Number 00-399024X ; 2) ARTHROSCOPY TRAY,

MEDLINE INDUSTRIES, LP - Northfield

Ventralight ST w EchoPS 4"x6" Ellipse- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removab

Davol, Inc.

Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for int

Cordis US Corp

AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode

Ad-Tech Medical Instrument Corporation