Medical Device Recalls
FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.
4,100 total recalls
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. C V
MEDLINE INDUSTRIES, LP - Northfield
Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single an
Siemens Medical Solutions USA, Inc
RayStation 11.0.0.951, 11.0.1.29, 11.0.3.116 & 11.0.4.15. Radiation Therapy Treatment Planning System.
RAYSEARCH LABORATORIES AB
REF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 mL/min, STERILEEO, RxOnly
Becton Dickinson Infusion Therapy Systems, Inc.
Ingenia 1.5T, 1.5T CX, and 1.5T S; Model number (REF): 1. 781315 (1.5T), 2. 781341 (1.5T), 3. 781396 (1.5T), 4. 782115
Philips North America
Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Broch
Baxter Healthcare Corporation
Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x
Philips Healthcare
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE YANKAUER SUCTION TUBE 8.5" C10, Model Number 96-417
Sklar Instruments
VIDAS SARS-COV-2 IgM, Ref 423833-01
bioMerieux, Inc.
Baxter Equipo de transferencia para DP MiniCap de vida util prolongada con pinza de torsion, 5C4482S
Baxter Healthcare Corporation
Constellation Vision System, REF: 8065751150
Alcon Research, LLC
ABBOTT DIAGNOSTICS ARCHITECT FREE T4ABBDIA CALIBRATOR.
Mckesson Medical-Surgical Inc. Corporate Office
BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD
Becton, Dickinson and Company, BD Bio Sciences
smiths medical medex CBSS-5ML Zweifach set, Model Number DPSHC0090
Smiths Medical ASD Inc.
GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5, Part Number 5867474-03; M
Wipro GE Healthcare Private Ltd.
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, PASS Tray REF: 8888104
Covidien LP
Lumbar Tray Catalog 1091
Busse Hospital Disposables, Inc.
Ingenia Elition S, Magnetic Resonance System.
Philips North America Llc
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180050
TELEFLEX LLC
Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.2MM ANGCE Model/Catalog Number: 8065983265 Software Version: N/A P
Alcon Research LLC
PE Centrifuge Temperature Controlled, REF: B36366, a component of the Power Express.
Beckman Coulter Biomedical GmbH
VITROS 5600 Integrated System - Refurbished . For use in the in vitro quantitative, semi-quantitative, and qualitative
Ortho-Clinical Diagnostics, Inc.
Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.
Percussionaire Corporation
MEDLINE Medical Procedure Kits labeled as CLOVIS HYSTEROSCOPY, CSC-N PELVISCOPY, D AND C PACK, D&C HYSTER PACK, FLWR GYN
Medline Industries, LP
Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive d
Trinity Biotech USA
Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part Numbers C-PTIS-100-HC-G-EU-FLEX7.5 (G57695)
Cook Incorporated
Hillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio); Diagnostic spirometer
Baxter Healthcare Corporation
IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software
Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0¿ LNR G 28MM 140-32-27 AM EHXL 0¿ LNR G 32MM 140-
Exactech, Inc.
ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing Kit, 14Fr Introducer, 13cm&25cm
Abiomed, Inc.
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