Medical Device Recalls

Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use Guide S

Olympus Corporation of the Americas

HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigationa

Thoratec Corp.

regard BASIC NEURO, NU00259S, Item Number 800021019; neuro surgery convenience kit

ROi CPS LLC

Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174

Medicrea International

Brand Name: MediHoney ¿ Product Name: MediHoney¿ Paste Model/Catalog Number: 31505 Product Description: MediHoney¿ Pa

Integra LifeSciences Corp. (NeuroSciences)

Nonsterile Femoral Angiography Drape, Catalog Numbers: a) 29460NB, b) 29456NB - Product Usage: intended to be used as pr

Cardinal Health 200, LLC

Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.

CHANGE HEALTHCARE CANADA COMPANY

MEGA 8Fr 50cc Intra-Aortic Balloon Catheter

Datascope Corporation

SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A

C.R. Bard Inc

ST OR MAYO HEGAR NEEDLEHOLDER 6"(OR2500), Medline Item No. 67870

MEDLINE INDUSTRIES, LP - Northfield

KARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123

Karl Storz Endoscopy

Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Num

Meridian Bioscience Inc

Intera 1.0T Omni/Stellar, Magnetic Resonance System.

Philips North America Llc

VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS

Milestone S.R.L.

WALLFLEX PC ESOPH STENT 18/23MM X 123MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intende

Boston Scientific Corporation

Custom Procedure Kit, REF: K12T-11077

Merit Medical Systems, Inc.

Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional accessory for Se

Remel, Inc

(1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number 781359)

Philips North America

Prismaflex HF20 Set (product code 109841). For use in providing continuous fluid management and renal replacement thera

Baxter Healthcare Corporation

Medtronic SynchroMed II, Model 8637-20, Programmable pump

Medtronic Neuromodulation

3M Steri-Drape, Medium Drape with Incise Film, REF 1060, general surgery drape

3M Healthcare Business

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes JUDKINS PACK DYNJ51126 AN

Medline Industries, LP

Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD Siemens Material Number (SMN):

Siemens Healthcare Diagnostics, Inc.

Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700RE Software Ve

SunMed Holdings, LLC

MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)

PATH

Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAM, Pack Number DYNDH1446A; 2) ARTHRO

MEDLINE INDUSTRIES, LP - Northfield

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List

Smiths Medical ASD Inc.

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-32-XX, Acumatch

Exactech, Inc.

Medshape Universal Joints, REF: DNE-9000-UJ

Medshape, INC.

Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 151760212

DePuy Orthopaedics, Inc.