Medical Device Recalls

Trilogy Evo, Garbin Evo, and Aeris EVO, Model Numbers DS2110X11B, IN2110X15B, JP2110X16B, AU2110X15B, LA2110X15B, CA2110

Philips Respironics, Inc.

0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML FILL SYRINGE/9210; NURSE ASSIST: 3ML IV F

Nurse Assist, LLC

SS 4.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1365R1

Busse Hospital Disposables, Inc.

VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Dat

Ortho-Clinical Diagnostics, Inc.

Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing.

B BRAUN MEDICAL INC

Vasoshield Syringe Packs, Model VH-5001

Maquet Cardiovascular, LLC

SmartPath to dStream for XR and 3.0T- For use as a diagnostic device to obtain cross-sectional images, spectroscopic im

Philips North America Llc

KING LTSD,SIZE 2.5, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide paten

King Systems Corp. dba Ambu, Inc.

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

B Braun Medical Inc

MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG- Used for the percutaneous introduction of a guidewire into

Angiodynamics, Inc.

Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight, Long. Model/Catalog Number: 14-5011L The D

Kirwan Surgical Products, LLC

Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative determination of iron in human serum and

Siemens Healthcare Diagnostics, Inc.

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM US; the system utilizes an interactive dis

Boston Scientific Corporation

Medline Convenience Kits: 1) KIT UROLOGY SLING, Model Number: DYKMBNDL106; 2) KIT UROLOGY SLING, Model Number: DYKMBN

Medline Industries, LP

Medline brand medical procedure convenience kits, labeled as: 1) THORACENTESIS TRAY, REF 00-400616J; 2) HH PACK SONICAT

MEDLINE INDUSTRIES, LP - Northfield

Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 c

Randox Laboratories Ltd.

EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V

Olympus Corporation of the Americas

HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE

Heartware, Inc.

Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.1.1.2, 6.2.0.

RAYSEARCH LABORATORIES AB

MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, IC Tray REF: 8888101002H

Covidien LP

Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in sp

Medtronic Sofamor Danek USA Inc

NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R

Nobel Biocare Usa Llc

ZOLL 731 Ventilator (EMV+, AEV, Eagle II) - for MRI Compatible Devices - Operator's Guide and Quick Reference Guide (QRG

ZOLL Medical Corporation

Medline convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J ; 2) ANGIOGRAPHY DRAPE PACK, P

MEDLINE INDUSTRIES, LP - Northfield

BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;

Becton Dickinson & Company

Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versions: 5.1.0.X & 5.1.1.X;

PHILIPS MEDICAL SYSTEMS

Karl Storz SE & CO. KG, REF 11003MB, Grasping Forceps, Flexible 1 mm, Rx Only

Karl Storz Endoscopy

BD BACTEC Blood Culture System, labeled as the following: 1. BACTEC 9120 System, Catalog Numbers: 445570, 445702.

Becton Dickinson & Co.

ACCOLADE DR EL MRI (Model L331)

Boston Scientific Corporation

Medline procedural kits labeled as: 1) CAROTID ENDARTERECTOMY PK, Pack Number DYNJ85516; 2) PICC INSERTION TRA

MEDLINE INDUSTRIES, LP - Northfield