Medical Device Recalls

Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sheaths Model/Catalog Number: 61024BX, 61038

Olympus Corporation of the Americas

Brand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM Model/Catalog Number: EK087P Software Version: N

Aesculap Inc

LifeVentEVO2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)

Philips Respironics, Inc.

Ureteralscope- for endoscopic diagnosis and treatment within the ureter, kidney and biliary tract (common bile duct and

Aizu Olympus Co., Ltd.

SURG STRP 1/2X6 Model/Catalog Number: 801451. The surgical patties and surgical strips are indicated for the use in pr

Integra LifeSciences Corp.

Cardiac Workstation 5000. Product Number: 860439.

Philips North America Llc

Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.

Summit Medical, LLC

QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 10000-USA

Maquet Medical Systems USA

Heavy Metals Test

GET TESTED INTERNATIONAL AB

Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03

Medtronic Perfusion Systems

AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Port Tray - RX, Part Number 008786-19

Windstone Medical Packaging, Inc.

Stryker Hoffmann II Connecting Rod Micro 3 x 30mm. Catalog Number: 50796030.

Stryker GmbH

Bard¿ Lopez Valve¿ with ENFit, REF EN0056000

C.R. Bard Inc

GE SIGNA Artist Evo, Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498

Siemens Healthcare Diagnostics, Inc.

GE Nuclear Medicine 600/800 series systems, specifically: a) BRIVO B615 3/8 inch DHP BJG NR, b) BRIVO 615 3/8 inch,

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

iQ Waste Well Adapter, Part Number: 700-3393

Beckman Coulter, Inc.

stryker Blueprint Mixed Reality Box Base, Catalog Number MRUE204, packaged in stryker Blueprint Mixed Reality Instrument

Tornier S.A.S.

GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.

GE Healthcare

VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack

Ortho-Clinical Diagnostics, Inc.

ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)

Healthmark Industries Co., Inc.

EZDilate Fixed Wire Balloon 18-19-20. Indicated for endoscopic dilation of strictures of the esophagus in adults and ado

Olympus Corporation of the Americas

DeRoyal UNIVERSAL PACK, REF 89-9558.03

DeRoyal Industries Inc

EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002

Datex-Ohmeda, Inc.

NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a.0.5mL Oral Syringe Orange NonS

Avanos Medical, Inc.

ABBOTT DIAGNOSTICS ARC CARBON DIOXIDE6X5ML B CALIBRATOR.

Mckesson Medical-Surgical Inc. Corporate Office

SM_40HF_B_D_VIR3.004, Mobile X-ray system

SEDECAL SA

AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098

Physio-Control, Inc.

Cone with Male Tubing, Non-Locking, Ellik Evacuator. Model Number: 191-NRS. The Ellik Evacuator and adapter accessor

Olympus Corporation of the Americas