Medical Device Recalls

BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025

Cypress Medical Products LLC

The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.

DIXI MEDICAL USA

Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with either of the following: 35700BAX2 (Spe

Baxter Healthcare Corporation

Blood Type Test

GET TESTED INTERNATIONAL AB

Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD AST

Remel Inc

Ingenia 1.5T -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of th

Philips North America Llc

SmartPath to Ingenia Elition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images a

Philips North America Llc

PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050

Oculus Technologies of Mexico, S.A. de C.V.

ARTHROSCOPY PACK-Procedure Kit Catalog Number: TNAR22U

American Contract Systems Inc

Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: IV START BOX

MEDLINE INDUSTRIES, LP - Northfield

Proxima Drape labeled as MINOR PACK and LAPAROSCOPY. Sterile surgical drape.

MEDLINE INDUSTRIES, LP - Northfield

EndoVive 20Fr Push Safety PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pedi

Boston Scientific Corporation

Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Stryker Sustainability Solutions

GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR355 and SIGNA MR360 System, nuclear magne

GE Healthcare, LLC

Micro Joystick R-net. Electrical wheelchair component.

mo-Vis BVBA

MEDLINE Urethral Catheter, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. DYND13508 - 08 Fr; 2

Medline Industries, LP

Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C, INFX-

Canon Medical System, USA, INC.

Medline convenience kits: INPATIENT CENTRAL LN DRSG KIT DYNDC3525 PICC/CVC/MIDLINE DRSG CHG KIT DT13191A PORT

Medline Industries, LP

a. BECTON DICKINSON BD Vacutainer C&S Preservative Urine Tube TUBE, URINE COLL PLAS 4ML (100/BX 10BX/CS), Model Number:

Mckesson Medical-Surgical Inc. Corporate Office

ET Rigid Abutment (Mini) Size: 4.5D 2.0G/H 4.0H- Intended for use with a dental implant to provide support for prostheti

Hiossen Inc.

CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 5" (12.7CM) DEEP STERRAD COMPATIBLE, REF CD1-5

Carefusion 2200 Inc

(1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNETOM Sempra, MAGNETOM Free.Max, MAGNETOM Mic

Siemens Medical Solutions USA, Inc

PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104

Heartware, Inc.

Atellica CH Triglycerides_2: in vitro diagnostic use in the quantitative determination of triglycerides in human serum a

Siemens Healthcare Diagnostics, Inc.

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112

Olympus Corporation of the Americas

Brand Name: Geneva Product Name: Brachytherapy Applicator Product Description: The device is intended for intracavitar

Elekta, Inc.

Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalog Number: SL-2010M20

B BRAUN MEDICAL INC

Filter + Catheter Mount, REF 191667-000100, OUS only. Catheter mount for circuit-patient connection (Endotracheal tube a

TELEFLEX LLC

SurgiMend MP; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm, 20x20 cm, 13x25 cm, 16x20 cm, 20x

TEI Biosciences, Inc.

NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) REF 8229306

Medtronic Xomed, Inc.