Medical Device Recalls

RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A

Fresenius Medical Care Holdings, Inc.

Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 14Fr., 48in Long, REF EN0046140

C.R. Bard Inc

Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers: DCF-E110SG-DE/1 (German language), D

Defibtech, LLC

Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888

Covidien, LP

Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code 8881570125 The proposed device is indic

Cardinal Health

Artis Q zeego, Model Number 10848283

Siemens Medical Solutions USA, Inc

Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035; 2) KIT SURG ONC INSERT CENT.VENOU, Model Numb

Medline Industries, LP

SmartPath to dStream for 3.0T Model Number (REF): 782145

Philips North America Llc

STERILE POVIDONE, REF DYNDA2061

MEDLINE INDUSTRIES, LP - Northfield

Medline Convenience Kits: 1) DYNDA3003, Model Number: DENTAL PACK; 2) DYNJ87157, Model Number: GULLO SURGICAL PACK

Medline Industries, LP

Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size REF Number 0.0 50005 0.5

SunMed Holdings, LLC

SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for Vagus Nerve Stimula

LivaNova USA, Inc.

MiniMed 620G Insulin Pump (MMT-1750)

Medtronic MiniMed, Inc.

2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.

Synthes (USA) Products LLC

RayStation 13.0.0.1547, 13.1.0.144 & 13.1.1.89. Radiation Therapy Treatment Planning System.

RAYSEARCH LABORATORIES AB

GEO-MED OPTHALMOLOGY CSTM PCK, REF 89-6387.09

DeRoyal Industries Inc

Medline Convenience kits labeled as: 1) ADMIT KIT , Pack Number DYKA1225B; 2) BRANSON SUPPLEMENTAL PACK , Pack Numb

MEDLINE INDUSTRIES, LP - Northfield

JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM

Smith & Nephew, Inc.

ZAP-X Radiosurgery System, Model: 300150

Zap Surgical Systems

Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001

Tenderneeds Fertility LLC

REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile

Osteomed, LLC

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-22-XX, Novation

Exactech, Inc.

BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of

Becton Dickinson & Co.

The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is a compounding device used in t

Baxter Healthcare Corporation

Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep Stimu

Boston Scientific Neuromodulation Corporation

LIPOSORBER System, Model: LA-15, consisting of: Apheresis machine, product# 101445 model: MA-03, and disposables

Kaneka America Corp

HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of

Boston Scientific Corporation

SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aor

Datascope Corp.

Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe

Medline Industries, LP

Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number C-TCCSB-500-UNI, Order Number G321

Cook Incorporated