Medical Device Recalls

GE Healthcare Optima 680 Expert, Model number 6670000; X-ray/computed tomography system

GE Healthcare (China) Co., Ltd.

Philips Azurion system, Interventional fluoroscopic x-ray system. System Product Name - Model Numbers Azurion 3M12 -7

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

3,65 m Extension Set with Luer-lock Connector

Baxter Healthcare Corporation

Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.

Abiomed, Inc.

Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and

Randox Laboratories Ltd.

Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to 2.6.8 (Build 2220). Device Type

MedicalCommunications GmbH

GYROSCAN T5-NT, Magnetic Resonance System.

Philips North America Llc

Medline CHEST TUBE INSERTION TRAY ADUL, REF CHT1165; medical procedure convenience kit

MEDLINE INDUSTRIES, LP - Northfield

stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, packaged in stryker Blueprint Mixed Reality I

Tornier S.A.S.

Heavy Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN: THDOC-35-60-0-3 G11949 C-HDOC-18-40-0-2

Cook Incorporated

Medline convenience kits labeled as: 1) MAJOR PROCEDURE, Medline Kit SKU CDS982040U; 2) OPERATIVE LAP P&S SURGICAL,

Medline Industries, LP

Infusomat UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV-Used with an electrically-powered infusion pump for intravenous (IV)

B. Braun Medical, Inc.

Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,

Philips Ultrasound, LLC

regard BASIC NEURO, NU00259R, Item Number 800021018; neuro surgery convenience kit

ROi CPS LLC

Medline Convenience Kits: 1) KIT ACES INSERT PEG, Model Number: DYKMBNDL130; 2) KIT ACES INSERT PEG, Model Number: DY

Medline Industries, LP

RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component

Ossur H / F

Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.

Cepheid

Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S

Olympus Corporation of the Americas

STERILE PVP SOLUTION, REF DYNDA1907

MEDLINE INDUSTRIES, LP - Northfield

GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used in FLUORESCENT PROC. (QUAL),

WALLAC OY

Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16

Galt Medical Corporation

PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825; c) 50 tubes, REF 597850; d) 25 grams, REF

Entopsis , Inc.

Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial f

Medtronic, Inc.

ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model num

PROTERIXBIO

REGARD Vitrectomy Tray

ROi CPS LLC

GE Healthcare Revolution Eagle, Model Number 5849504-3, X-ray/computed tomography system

GE Healthcare (China) Co., Ltd.

15 Liters Drain Bag

Baxter Healthcare Corporation

Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers: DVPC3D1, DVPC3D4; b. Crome DR ICD, Model

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

GE Vscan Extend, being sold as "Vscan Extend Dual USB"

GE Healthcare, LLC

Cobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter Defibrillator

Medtronic Inc.