Medical Device Recalls

Schiff Reagent, Hotchkiss-McManus, packaged in an amber glass bottle with a black polypropylene cap.

EMD Millipore Corporation

Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 834338

QUIDEL ORTHO

Bard¿ Nasogastric Sump Tube and PreVent¿ Anti-Reflux Filter and Lopez Valve¿ with ENFit, 18Fr., 48in Long, REF EN0056180

C.R. Bard Inc

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGI

MEDLINE INDUSTRIES, LP - Northfield

Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 35-55mm Model/Catalog Number: MR2102035 Product D

SEASPINE ORTHOPEDICS CORPORATION

Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF 200252904, Size 4

Wright Medical Technology, Inc.

Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Respiratory Syncytial Virus A Strain Long. Targ

Microbiologics Inc

Syphilis Test

GET TESTED INTERNATIONAL AB

Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalo

Randox Laboratories, Limited

Description/REF: CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH; CVC KIT: 3-LUMEN 12 FR X 16 CM/AK-12123-F; CVC KIT: 3-L

ARROW INTERNATIONAL, LLC

MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data proce

Medical Information Technology, Inc.

FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010

Qiagen Sciences LLC

Oakworks Bed (Emergency Field Bed); Model No. OBMPBR361980A6TTGRCS

Oakworks Inc

Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator

Accuray Incorporated

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CRANIOTOMY CDS-1, Model Numb

MEDLINE INDUSTRIES, LP - Northfield

Maquet Hanaulux HLX3000 OR Light Systems, Model Numbers and Catalog Numbers H3 BC - HM567811111C

Getinge Usa Sales Inc

BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P, REF: 169-96 containing software version 3.9.1.9

CareFusion 303, Inc.

ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS8-

ConMed Corporation

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List N

Smiths Medical ASD Inc.

Ivalon Eye Wick 20cm- Intended to be used for the removal and collection of fluids from the Opthalmic surgical site.

Carwild Corporation

Captus 4000e Thyroid Uptake System with Well. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe t

Mirion Technologies (Capintec), Inc.

Brand Name: DONJOY Product Name: ICEMAN CLASSIC CUBE Model/Catalog Number: 11-0494 Software Version: no Product Desc

DJO, LLC

Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 70 MM Item Number: 11-301335

Biomet, Inc.

Non-sterile procedural trays labeled as CRANI, 2 per case

MEDLINE INDUSTRIES, LP - Northfield

COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-FLEX-HC, Ord

Cook Incorporated

DxI 9000 Access Immunoassay Analyzer, Part Number C11137

Beckman Coulter, Inc.

Applied Medical Technology, Inc., NutraGlide, 6 F- 8 F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-06055-I

Applied Medical Technology Inc

EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232

Philips Ultrasound Inc

Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interventional Fluoroscopic X-Ray System

Siemens Medical Solutions USA, Inc

Calibrate (80 kVp) screened nanoDot D2DNS, Model Number 03064-OTO; radiation monitoring dosimeter used with the microSTA

Landauer