Medical Device Recalls

L8-4 Transducer Probe

Philips Ultrasound, Inc

EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial retu

Medtronic Perfusion Systems

20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular procedures in conjunction with interven

Abbott Vascular Inc

Medline custom medical procedure kits labeled as: 1) CERVICAL PACK-LF, REF DYNJ0867145G; 2) CERVICAL SPINE PACK HUM

MEDLINE INDUSTRIES, LP - Northfield

Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis

Coloplast Manufacturing US, LLC

DEX Ophthalmic Tissue Forceps, 25ga DEX Nano Tapered AWH Forceps, Model/Catalog Number: DVF4005-25

Katalyst Surgical, LLC

Happiest Baby, Inc Pre-loved SNOO Smart Sleeper Model:S1000

Happiest Baby, Inc

Artis zee multi-purpose, Model Number 10094139

Siemens Medical Solutions USA, Inc

Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number

Exactech, Inc.

Infusomat SPACE PUMP IV SET, 127 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administratio

B. Braun Medical, Inc.

ICD-VR DVBC3D4 EVERA S DF4 GLOB, Model Number DVBC3D4; Implantable Cardioverter Defibrillators

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.

Olympus Corporation of the Americas

Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830

INSPIREMD Inc

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)

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