Medical Device Recalls

Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

Siemens Healthcare Diagnostics, Inc.

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 125CM (5PK), REF H749085262302; cardiac catheter

Boston Scientific Corporation

ORTHO CLINICAL DIAGNOSTICS INC TOTAL BILI-ALKP XT (L-SEQUESTER) (300/PK) REAGENT.

Mckesson Medical-Surgical Inc. Corporate Office

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001315;

Beaver Visitec International, Inc.

VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 20-

Ortho-Clinical Diagnostics

OES 4000 Hysteroscope, Model/Catalog Number: A4674A

Olympus Corporation of the Americas

MultiLab Series II REVO non-invasive vascular diagnostic device, Model Number 12950-0000-01

Unetixs Vascular, Inc.

Sorbitol Intolerance Test

GET TESTED INTERNATIONAL AB

Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; Cardiopulmonary bypass vascular c

Medtronic Perfusion Systems

CURAD REUSABLE GEL HOT/COLD PACK

MEDLINE INDUSTRIES, LP - Northfield

MyoSPECT System, Model H3912AA and H3912B, and MyoSPECT ES System, Model H3912AB and H3912BD, dedicated cardiac SPECT (

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

Hill-Rom PRO+ MRS Surface For Versacare mattress, REF P3255A02.

Baxter Healthcare Corporation

Bard¿ Nasogastric Sump Tube and PreVent¿ Filter and Lopez Valve¿ with ENFit, 16Fr., 48in Long , REF EN0056160

C.R. Bard Inc

Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500I (IPN000324), cardiac pump

ARROW INTERNATIONAL Inc.

VIDAS CLINICAL VIDAS BRAHMS PROCALCITONIN 60T, CATALOG 30450-01

Biomerieux Inc

HeartWare HVAD Pump Kit, REF 1104JP

Heartware, Inc.

Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380040

TELEFLEX LLC

Cirq Arm System 2.0

Brainlab AG

Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System

Zimmer Biomet Spine Inc.

Medical convenience kits Item Number/Description RCEN25B ENT SDSC 0246972 RCHN27D HEAD AND NECK RCH 0246951

American Contract Systems Inc.

Volara System. Blue Ventilator Adapter Module. Intermittent positive pressure breathing device component.

Baxter Healthcare Corporation

SafeDAY set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space

B Braun Medical Inc

Philips Respironics DreamWear Full Face Mask

Philips Respironics, Inc.

ADVIA Centaur Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN

Siemens Healthcare Diagnostics, Inc.

Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.

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

Centurion medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SURGICAL ENT PREP KIT, Medline

Medline Industries, LP

LAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41G

American Contract Systems Inc

Centurion Manual surgical kits labeled as: a) STERILE S/B WIRE SCISSOR, Product Code 65140; b) SHARP/SHARP SCISSORS

MEDLINE INDUSTRIES, LP - Northfield

therascreen FGFR RGQ RT-PCR kit (US IVD) REF 874721

Qiagen Sciences LLC

Medline procedural kits labeled as: 1) LEEP PACK, Pack Number DYNJ40348G; 2) TRAB BUCKLE DSC, Pack Number DYNJ63036

MEDLINE INDUSTRIES, LP - Northfield