Medical Device Recalls

GE Healthcare Revolution ACE, Model number 6670000-3; X-ray/computed tomography systems

GE Healthcare (China) Co., Ltd.

Philips Incisive CT

Philips Healthcare (Suzhou) Co., Ltd.

3M Attest Steam Chemical Integrators, REF 1243B

3M Company - Health Care Business

Female SS 3.5MM Pellet Insertion Tray Catalog Number: B1568

Busse Hospital Disposables, Inc.

Coapt Dome Electrode, Gen2 system, cutaneous electrode

Coapt LLC

t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)

Tandem Diabetes Care, Inc.

Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices. Descripti

Trividia Health, Inc.

EcoGel 100 Imaging Gel, EcoGel 200 MultiPurpose Gel (Blue), EcoGel 200 MultiPurpose Gel (CLEAR), and EcoLotion Transmiss

AMTEC SALES Inc

MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1723

MEDLINE INDUSTRIES, LP - Northfield

Oculus Pentacam AXL , Ref 70100, CE 0123

Oculus Optikgeraete GMBH

stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packaged in stryker Blueprint Mixed Reality Inst

Tornier S.A.S.

GE HealthCare OEC 9900 Elite C-arm Systems.

GE Medical Systems, LLC

Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1.

Philips North America

The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emi

MAX LUX CORP

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT s

Philips North America Llc

REF 8L92-42, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161866

Abbott Laboratories

Salem Sump PVC Tubes: Product Code/Product Name: 8888265108 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque

Cardinal Health 200, LLC

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

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