Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 164 of 548
FDA Devices Moderate Nov 3, 2021
REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx …
W L Gore & Associates, Inc.
FDA Devices Moderate Nov 3, 2021
ASC PneumoLiner device, Part No. WA90500US (US market only) The Pneumoliner device is intended for use as a multiple instrument port and tissue co…
Olympus Corporation of the Americas
FDA Devices Low Nov 3, 2021
Pneupac paraPac plus 300 ventilator kit, REF P300NGB
Smiths Medical ASD Inc.
FDA Devices Moderate Nov 3, 2021
Bivona Aire-Cuf Endotracheal Tube
Smiths Medical ASD Inc.
FDA Devices Moderate Nov 3, 2021
REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx …
W L Gore & Associates, Inc.
FDA Devices Moderate Nov 3, 2021
BD Syringe Tip Cap Bulk Sterile Convenience Pak-1000 units/shelf carton. Used to seal syringes and maintain container closure integrity throughout th…
Becton Dickinson & Company
FDA Devices Moderate Nov 3, 2021
RAPTAR Laser Range Finders
Potomac River Group, Corp.
FDA Devices Moderate Nov 3, 2021
C315-HIS Delivery Catheter
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
FDA Devices Moderate Nov 3, 2021
REF/Catalogue Number GSXE0030, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx …
W L Gore & Associates, Inc.
FDA Devices Moderate Nov 3, 2021
Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Nov 3, 2021
REF/Catalogue Number GSX0020A, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx …
W L Gore & Associates, Inc.
FDA Devices Moderate Nov 3, 2021
REF/Catalogue Number GSXE0025B, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx…
W L Gore & Associates, Inc.
FDA Devices Moderate Nov 3, 2021
Cliquid MD version 3.4 software used in conjunction with Analyst MD software on SCIEX Citrine & 4500MD series liquid chromatography-tandem mass spect…
AB SCIEX
FDA Devices Critical Nov 3, 2021
ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used…
MEDTECH SAS
FDA Devices Moderate Nov 3, 2021
Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00
Elekta, Inc.
FDA Devices Moderate Nov 3, 2021
REF/Catalogue Number GSXE0030B, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx…
W L Gore & Associates, Inc.
CPSC Moderate Nov 3, 2021
Power Handles Recalled Due to Fire and Burn Hazards; Manufactured by Elektron Music Machines
Elektron Music Machines MAV AB, of Sweden
FDA Devices Moderate Oct 27, 2021
SIGNA Pioneer nuclear magnetic resonance imaging system
GE Healthcare, LLC
FDA Devices Moderate Oct 27, 2021
MPR Slotted Mallet, labeling etched onto devices as follows: Medical Products Resource 800.524.5194 www.m-p-r.com MPR-1120-1000 (01)008400014…
Implant Resource Inc
FDA Devices Moderate Oct 27, 2021
Foundation Kit
Stradis Medical, LLC dba Stradis Healthcare
FDA Devices Moderate Oct 27, 2021
REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE R, 2100099, UDI: (01)08033390018852
Limacorporate S.p.A
FDA Devices Moderate Oct 27, 2021
Optima MR450w 1.5T nuclear magnetic resonance imaging system
GE Healthcare, LLC
FDA Devices Moderate Oct 27, 2021
1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system
GE Healthcare, LLC
FDA Devices Moderate Oct 27, 2021
Herniatome, 17G x 15cm, Lumbar Type, Model Number 5091745
ADRIA SRL
FDA Devices Moderate Oct 27, 2021
Catalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy and Aspiration Tray, 11 G X 4"Biopsy/Aspiration needle, 15 G Aspiration Needle (Adjus…
Bard Peripheral Vascular Inc
FDA Devices Moderate Oct 27, 2021
smiths medical portex Loss of Resistance Device, REF 100/398/000
Smiths Medical ASD Inc.
FDA Devices Moderate Oct 27, 2021
IUD Insertion Pack
Stradis Medical, LLC dba Stradis Healthcare
FDA Devices Moderate Oct 27, 2021
6.5MMX165MM CANNULATED SCREW
Smith & Nephew, Inc.
FDA Devices Moderate Oct 27, 2021
Catalog # BEK3411, Ecomomy Jamshidi Bone Marrow Biopsy Tray, 11 G X 4"Biopsy/Aspiration needle, sterile, Qty: 10, Single Use Only, RX only. Exp. Dat…
Bard Peripheral Vascular Inc
FDA Devices Moderate Oct 27, 2021
SIGNA Architect nuclear magnetic resonance imaging system
GE Healthcare, LLC
FDA Devices Moderate Oct 27, 2021
IUD Insertion Kit
Stradis Medical, LLC dba Stradis Healthcare
FDA Devices Moderate Oct 27, 2021
Easi-Care Gait Belt Metal Buckle (54", 60", and 72" lengths)
Kinsman Enterprises Inc
FDA Devices Critical Oct 27, 2021
Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) with the below Model Numb…
Datascope Corp.
FDA Devices Moderate Oct 27, 2021
Atellica IM 1600 Analyzer, SMN 11066000
Siemens Healthcare Diagnostics, Inc
FDA Devices Moderate Oct 27, 2021
SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system
GE Healthcare, LLC
FDA Devices Moderate Oct 27, 2021
Herniatome, 17G x 9cm, Cervical Type, Model Number 5091749
ADRIA SRL
FDA Devices Moderate Oct 27, 2021
Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
Canon Medical System, USA, INC.
FDA Devices Moderate Oct 27, 2021
Discovery MR750w 3.0T nuclear magnetic resonance imaging system
GE Healthcare, LLC
FDA Devices Moderate Oct 27, 2021
EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232
Philips Ultrasound Inc
FDA Devices Moderate Oct 27, 2021
SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051
DiaSorin Molecular LLC
FDA Devices Moderate Oct 27, 2021
medfusion Stopcock, 1-way and 4-way, Model Numbers (REF): a. 081-101BE b. 081-101GE c. 081-101GEE d. 081-101NE e. 081-102NE f. 081-102RE g. 08…
Smiths Medical ASD Inc.
FDA Devices Moderate Oct 27, 2021
SIGNA Voyager nuclear magnetic resonance imaging system
GE Healthcare, LLC
FDA Devices Moderate Oct 27, 2021
Kit: Central Line Dres Change 20/Cs
Medical Action Industries, Inc. 306
FDA Devices Moderate Oct 27, 2021
SIGNA Artist nuclear magnetic resonance imaging system
GE Healthcare, LLC
FDA Devices Moderate Oct 27, 2021
Discovery MR750 3.0T nuclear magnetic resonance imaging system
GE Healthcare, LLC
FDA Devices Moderate Oct 27, 2021
Tenaculum, Plastic
Stradis Medical, LLC dba Stradis Healthcare
FDA Devices Moderate Oct 27, 2021
Atellica IM 1300 Analyzer, SMN 11066001
Siemens Healthcare Diagnostics, Inc
CPSC Moderate Oct 22, 2021
Walmart Recalls Better Homes and Gardens Essential Oil Infused Aromatherapy Room Spray with Gemstones Due to Rare and Dangerous Bacteria; Two Deaths …
FDA Devices Moderate Oct 20, 2021
Flower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and can be used with any plate that has been cleared as part of the Flower …
Flower Orthopedics Corporation
FDA Devices Critical Oct 20, 2021
ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser Btl
National Distribution & Contracting Inc