Medical Device Recalls

ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the therap

Siemens Medical Solutions USA, Inc

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE BACKHAUS TWL CLP STER 3.5 CS50, Model Number 96-263

Sklar Instruments

FoundationOne CDx (F1CDx), RAL-0003 version 31.0

Foundation Medicine, Inc.

Pediatric Craniotome Ref:CRANI-P-G1

The Anspach Effort, Inc.

Aligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a

Windstone Medical Packaging, Inc.

Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010

ICU Medical Inc

OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscopic C-Arm imaging sy

GE OEC Medical Systems, Inc

ICD COBALT XT HF QUAD OUS, Model Number DTPA2QQG; Implantable Cardioverter Defibrillators

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

CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281

Beckman Coulter Mishima K.K.

ETEST CLINICAL MEROPENEM MP 32 US S30, CATALOG 412401

Biomerieux Inc

Directional Laser Probe with Alcon / Lumenis connector (27 gauge / 0.4 mm)

D.O.R.C. Dutch Opthalmic Research Center Intl B.V.

QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. BEQ-

Maquet Medical Systems USA

Baxter Floseal Hemostatic Matrix Fast Prep, Product Codes: a) ADS201844, 5 mL b) ADS201845, 10mL

Baxter Healthcare Corporation

ETEST CLINICAL ERAVACYCLINE ERV US S30, CATALOG 421553

Biomerieux Inc

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: PC

Merit Medical Systems, Inc.

Description/REF: EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1; EPIDURAL CATHETERIZATION KIT: 19 GA/AK-05501; EP

ARROW INTERNATIONAL, LLC

progenamatrix Human Keratin Matrix, sterile, Rx, with the following model numbers: (1) PM2012, 12 x 2 cm; (2) PM3002, 2

ProgenaCare

ICD-DR DDBB2D4 EVERA XT IS1/DF4 INTL, Model Number DDBB2D4; Implantable Cardioverter Defibrillators

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

Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18120-000; b) 18120-KIT; c) 18120-SET; radiation monitoring d

Landauer

Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in blood, serum, plasma or pH of blood,

Nova Biomedical Corporation

HENRY SCHEIN, LOOP RECORDER PACK, Item No.570-2891

Stradis Medical, LLC dba Stradis Healthcare

Heartstring III Proximal Seal System. Intravascular anastomosis occluder.

Maquet Cardiovascular, LLC

SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, TFL-FBX

Olympus Corporation of the Americas

Infusomat UNIV. 60 DROP PUMP SET, 2 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV)

B. Braun Medical, Inc.

3.0 Liter Disposable Set (4 sets/case). Model Number: 903-00032. The P/N 903-00032 consists of 4 Large Volume Rese

Belmont Instrument LLC

REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cytometry for fluorescence compensation.

Becton, Dickinson and Company, BD Bio Sciences

Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380065

TELEFLEX LLC

Philips Allura Xper FD10 system with an ADN7NT patient table. Model Number: 722010, Software Version Number 8.1.100.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

t:slim X2 Insulin Pump with Interoperable Technology

Tandem Diabetes Care, Inc.

The Medline General Surgery Tray is customized to meet requirements of the hospitals and health care professionals utili

MEDLINE INDUSTRIES, LP - Northfield