FDA Medical Devices
U.S. Food and Drug Administration — Medical device recalls
26,000 recalls · Page 53 of 520
Critical Oct 23, 2024
KINOVA Jaco assistive robot. Model Numbers: PJ 0000 0001, PJ 0000 0012, PJ 0090 0001, PJ 0090 0006, KR MJ2 0001. Jaco replaces the function of the up…
Kinova Inc
Moderate Oct 23, 2024
The Graft Tube is an optional instrument which, as designed, can be filled with flowable graft material, then advanced through the Access Portal. A P…
Spineology, Inc.
Moderate Oct 23, 2024
Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR BLUE Model/Catalog Number: 4329BL Product Description: ROLLING WALKER MOBILITY AID
Nova Ortho-Med Inc
Moderate Oct 23, 2024
Leica Biosystems Cryostat Model Number CM1850, Material Numbers: a) 14047131148, b) 14901850001, c) 14901850001R0501, d) 1491850UVUL; for freezing…
LEICA BIOSYSTEMS NUSSLOCH GMBH
Moderate Oct 23, 2024
Leica Biosystems Cryostat Model Number CM3050 S, Material Numbers: a) 14047033518, b) 14903050S01, c) 14903050S02, d) 14903050S03; for freezing and…
LEICA BIOSYSTEMS NUSSLOCH GMBH
Moderate Oct 23, 2024
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM JAPAN; the system utilizes an interactive display to provide physicians…
Boston Scientific Corporation
Moderate Oct 23, 2024
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM US; the system utilizes an interactive display to provide physicians wi…
Boston Scientific Corporation
Moderate Oct 23, 2024
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST US; the system utilizes an interactive display to provide p…
Boston Scientific Corporation
Moderate Oct 23, 2024
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EU + ROW; the system utilizes an interactive display to provide physici…
Boston Scientific Corporation
Moderate Oct 23, 2024
Horizon Cardiology Hemo. Version 12.2.
CHANGE HEALTHCARE CANADA COMPANY
Moderate Oct 23, 2024
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
Moderate Oct 23, 2024
Leica Biosystems Cryostat Model Number CM1510 S, Material Numbers: a) 491510C002, b) 1491510C003; for freezing and sectioning tissue samples
LEICA BIOSYSTEMS NUSSLOCH GMBH
Moderate Oct 23, 2024
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
Moderate Oct 23, 2024
Leica Biosystems Cryostat Model Number CM1950, Material Numbers: a) 14047742467, b) 1491950C1US, c) 1491950C2US, d) 1491950C3US; for freezing and se…
LEICA BIOSYSTEMS NUSSLOCH GMBH
Moderate Oct 23, 2024
MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B
Merit Medical Systems, Inc.
Moderate Oct 23, 2024
DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A
Merit Medical Systems, Inc.
Moderate Oct 23, 2024
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.
Moderate Oct 23, 2024
The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative etermdination of human thyroid-stimulatin…
Beckman Coulter, Inc.
Moderate Oct 23, 2024
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
Moderate Oct 23, 2024
Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN7852/C, IN7130/C
Merit Medical Systems, Inc.
Moderate Oct 23, 2024
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
Moderate Oct 23, 2024
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.
Moderate Oct 23, 2024
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL US; the system utilizes an interactive display to provide physicia…
Boston Scientific Corporation
Moderate Oct 23, 2024
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM US; the system utilizes an interactive display to provide physicians wi…
Boston Scientific Corporation
Moderate Oct 16, 2024
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
Moderate Oct 16, 2024
Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical imaging and non-imaging data…
Agfa Healthcare NV
Moderate Oct 16, 2024
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.
Moderate Oct 16, 2024
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
Moderate Oct 16, 2024
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.
Moderate Oct 16, 2024
Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1
Philips North America
Moderate Oct 16, 2024
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
Moderate Oct 16, 2024
Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
Inspire Medical Systems Inc.
Moderate Oct 16, 2024
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
Howmedica Osteonics Corp.
Moderate Oct 16, 2024
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/Code Numbers: a)¿¿¿¿¿ 2089507-120; b)¿¿¿¿ 2089507-129; c)¿¿¿¿¿ …
GE Healthcare
Moderate Oct 16, 2024
Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ConMed/Unimax Detachable Endo Pocket
MEDLINE INDUSTRIES, LP - Northfield
Moderate Oct 16, 2024
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.
Moderate Oct 16, 2024
iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616
Atrium Medical Corporation
Moderate Oct 16, 2024
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.
Moderate Oct 16, 2024
Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB.
AURIS HEALTH INC
Moderate Oct 16, 2024
FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
Qualigen Inc
Moderate Oct 16, 2024
MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.
MEDLINE INDUSTRIES, LP - Northfield
Moderate Oct 16, 2024
NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
Luminex Molecular Diagnostics Inc
Moderate Oct 16, 2024
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.
Moderate Oct 16, 2024
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.
Moderate Oct 16, 2024
Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications during primary and revision Tota…
Howmedica Osteonics Corp.
Critical Oct 16, 2024
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
Moderate Oct 16, 2024
3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
3M Company - Health Care Business
Moderate Oct 16, 2024
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.
Moderate Oct 16, 2024
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
MEDLINE INDUSTRIES, LP - Northfield
Moderate Oct 16, 2024
Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB
AURIS HEALTH INC