Medical Device Recalls

Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/GPN: IGTCFS-65-1-FEM-TULIP G52917; IGTC

Cook Medical Incorporated

Aeos Robotic Digital Microscope, Product Code: PV010

Aesculap Inc

Freeman Pancreatic Flexi-Stent Catalog Number: 6568

Hobbs Medical, Inc.

Medline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box

MEDLINE INDUSTRIES, LP - Northfield

Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Controls, & Immunodiffu

Immuno-Mycologics, Inc

MIVI Super 90 8F Guide Catheter, 95 cm, REF MIA-9095S-IDE, For Investigational Use Only; sterile, and Super 90 8F Guide

Mivi Neuroscience Inc

Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181040

TELEFLEX LLC

ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.

Siemens Medical Solutions USA, Inc

IMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, d) B20181743, e) B20181753, f) B2018176

Medicrea International

IUD Insertion Kit

Stradis Medical, LLC dba Stradis Healthcare

MIVI Super 90 Guide Catheters, MIVI Mi-Axus 8F Catheters, REF MIA-9080S (80 cm length); MIA-9090S (90 cm length), and MI

Mivi Neuroscience Inc

LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2030/11

Linkbio Corp.

Terragene Bionova PCD (PCD222-C)

TERRAGENE S.A.

PPM LOMBARD PRODUCTS R2A MEDIUM 10PLT, CATALOG M1065

Biomerieux Inc

Medline Kits containing ENFIT G-TUBE CONNECTOR 1. SKU DYKM2720 G/J TUBE CARE KIT 2. SKU ENFITDISCKIT ENFIT DISCH

Medline Industries, LP

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.

Olympus Corporation of the Americas

PrisMax System, Product Codes: a) 955558, b) 955627, c) 955701

Baxter Healthcare Corporation

Brand Name: AART Malar Implant Product Name: Malar Implant Model/Catalog Number: 401-202-5 Malar Implant style 2 size

DSAART LLC

MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, PASS Tray REF: 888810300

Covidien LP

Detector H. Pylori, Catalog Number IHP-30

Immunostics, Inc.

Philips Respironics Amara View Minimal Contact Full-Face Mask

Philips Respironics, Inc.

Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035A; 2) LVAD DRIVELINE TRAY, Model Number: DM1035

Medline Industries, LP

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST JAPAN; the system utilizes an

Boston Scientific Corporation

Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRBS4000; CONSOLE REFURB: Material Number

Boston Scientific Corporation

Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0320; Software

Olympus Corporation of the Americas

Kits of Convenience containing 1 of the 2 Item Numbers: 1. Item Number: 59-300 HAWK Warming Grid, 2. Item Number: 5

Safeguard US Operating LLC

Easi-Care Gait Belt Metal Buckle (54", 60", and 72" lengths)

Kinsman Enterprises Inc

Boston Scientific TCN Electrodes: REF: TCN-5, TCN Electrode, NITINOL, 5 cm x 0.45 mm (0.0175 in); REF:TCN-10, TCN Elec

Boston Scientific Neuromodulation Corporation

Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative determination of estradiol

Siemens Healthcare Diagnostics, Inc.

Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform

Fenwal Inc