Medical Devices Recalls

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST EU + RO; the system utilizes an interactive display to prov…

Boston Scientific Corporation

Leica Biosystems Cryostat Model Number CM1510 S, Material Numbers: a) 491510C002, b) 1491510C003; for freezing and sectioning tissue samples

LEICA BIOSYSTEMS NUSSLOCH GMBH

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE JAPAN; the system utilizes an interactive display to provid…

Boston Scientific Corporation

Leica Biosystems Cryostat Model Number CM1950, Material Numbers: a) 14047742467, b) 1491950C1US, c) 1491950C2US, d) 1491950C3US; for freezing and se…

LEICA BIOSYSTEMS NUSSLOCH GMBH

MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B

Merit Medical Systems, Inc.

DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A

Merit Medical Systems, Inc.

Monarch Inflation Device 30 atm/bar REF IN2130 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used…

Merit Medical Systems, Inc.

The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative etermdination of human thyroid-stimulatin…

Beckman Coulter, Inc.

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + INT Z UPGRADE JP; the system utilizes an interactive display to provi…

Boston Scientific Corporation

Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN7852/C, IN7130/C

Merit Medical Systems, Inc.

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + MOB Z UPGRADE JP; the system utilizes an interactive display to provi…

Boston Scientific Corporation

Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Insertion Tool Torque Device REF IN2430 Injector And Syringe, Angiographic/S…

Merit Medical Systems, Inc.

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL US; the system utilizes an interactive display to provide physicia…

Boston Scientific Corporation

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM US; the system utilizes an interactive display to provide physicians wi…

Boston Scientific Corporation

Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer Introducers are designed to perform as a gu…

Cook Incorporated

Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical imaging and non-imaging data…

Agfa Healthcare NV

Aligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in…

Windstone Medical Packaging, Inc.

IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVu…

Philips North America Llc

StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is intended as an…

Medtronic Navigation, Inc.

Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1

Philips North America

The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the planning and manual advancement of one or more…

QUANTUM SURGICAL SAS

Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.

Inspire Medical Systems Inc.

MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

Howmedica Osteonics Corp.

GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/Code Numbers: a)¿¿¿¿¿ 2089507-120; b)¿¿¿¿ 2089507-129; c)¿¿¿¿¿ …

GE Healthcare

Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ConMed/Unimax Detachable Endo Pocket

MEDLINE INDUSTRIES, LP - Northfield

Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use …

Windstone Medical Packaging, Inc.

iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616

Atrium Medical Corporation

Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use i…

Windstone Medical Packaging, Inc.

Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB.

AURIS HEALTH INC

FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer

Qualigen Inc

MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.

MEDLINE INDUSTRIES, LP - Northfield

NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468

Luminex Molecular Diagnostics Inc

MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515) and 3.5oz tube (Model Number …

Integra LifeSciences Corp.

Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use i…

Windstone Medical Packaging, Inc.

Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications during primary and revision Tota…

Howmedica Osteonics Corp.

Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3…

Zyno Medical LLC

3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

3M Company - Health Care Business

Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for us…

Windstone Medical Packaging, Inc.

MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.

MEDLINE INDUSTRIES, LP - Northfield

Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB

AURIS HEALTH INC

MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001

MEDLINE INDUSTRIES, LP - Northfield

NPW Group Recalls Halloween Projector Flashlights Due to Fire and Burn Hazards; Sold Exclusively at Target

BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.

Young Dental Manufacturing I, LLC

MiniMed 620G Insulin Pump, REF: MMT-1510, MMT-1710, MMT-1750; MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755; Min…

Medtronic MiniMed, Inc.

DVOT SARS-Cov-2 &Influenza A+B Antigen Combo Test Kit, Model Number FAT01

FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD

Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve

Percussionaire Corporation

Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve

Percussionaire Corporation

Healgen Series Reagent strips for Urinalysis are composed of several color pads aligned on a test strip. Each pad is employed for testing one assay i…

Healgen Scientific Llc

DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere,

Alcon Research LLC

Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in patients wit…

Outset Medical, Inc.