Medical device recalls
Device recalls are the largest single group in this archive, because the FDA logs corrections and removals as well as outright withdrawals. Many are handled entirely between the manufacturer and a hospital and need nothing from a patient. Each notice states who has to act.
13,634 stored notices, reported between Jun 20, 2012 and Sep 9, 2026. Newest first.
Reported Nov 3, 2021
Cliquid MD version 3.4 software used in conjunction with Analyst MD software on SCIEX Citrine & 4500MD series liquid…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ab Sciex
FDA (openFDA device enforcement)
Reported Nov 3, 2021
BD Syringe Tip Cap Bulk Sterile Convenience Pak-1000 units/shelf carton. Used to seal syringes and maintain container…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
FDA (openFDA device enforcement)
Reported Nov 3, 2021
Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Elekta, Inc.
FDA (openFDA device enforcement)
Reported Nov 3, 2021
ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtech Sas
FDA (openFDA device enforcement)
Reported Nov 3, 2021
C315-HIS Delivery Catheter
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
FDA (openFDA device enforcement)
Reported Nov 3, 2021
ASC PneumoLiner device, Part No. WA90500US (US market only) The Pneumoliner device is intended for use as a multiple…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
FDA (openFDA device enforcement)
Reported Nov 3, 2021
RAPTAR Laser Range Finders
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Potomac River Group, Corp.
FDA (openFDA device enforcement)
Reported Nov 3, 2021
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 3, 2021
Pneupac paraPac plus 300 ventilator kit, REF P300NGB
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Smiths Medical ASD Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 3, 2021
REF/Catalogue Number GSX0030A, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.W L Gore & Associates, Inc.
8 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 3, 2021
Concerto User Interface Software provided with the following systems: (1) Xstrahl 100 Electronic Brachytherapy - 100kV…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Xstrahl Limited
FDA (openFDA device enforcement)
Reported Oct 27, 2021
Herniatome, 17G x 15cm, Lumbar Type with with 20ga-30cm Introducer, Model Number 5091715
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Adria Srl
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 27, 2021
Catalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy and Aspiration Tray, 11 G X 4"Biopsy/Aspiration needle,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bard Peripheral Vascular Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 27, 2021
Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Canon Medical System, USA, Inc.
FDA (openFDA device enforcement)
Reported Oct 27, 2021
Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Cardiosave Hybrid Intra-Aortic Balloon Pump…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Datascope Corp.
FDA (openFDA device enforcement)
Reported Oct 27, 2021
SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DiaSorin Molecular LLC
FDA (openFDA device enforcement)
Reported Oct 27, 2021
P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fort Defiance Industries, LLC
FDA (openFDA device enforcement)
Reported Oct 27, 2021
SIGNA Premier nuclear magnetic resonance imaging system
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
9 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 27, 2021
MPR Slotted Mallet, labeling etched onto devices as follows: Medical Products Resource 800.524.5194 www.m-p-r.com…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Implant Resource Inc.
FDA (openFDA device enforcement)
Reported Oct 27, 2021
HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Instrumentation Laboratory
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 27, 2021
Easi-Care Gait Belt Metal Buckle (54", 60", and 72" lengths)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Kinsman Enterprises Inc.
FDA (openFDA device enforcement)
Reported Oct 27, 2021
REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE R, 2100099, UDI:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Limacorporate S.p.A
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 27, 2021
Kit: Central Line Dres Change 20/Cs
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medical Action Industries, Inc. 306
FDA (openFDA device enforcement)
Reported Oct 27, 2021
Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Xomed, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
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RecallNow is not a government agency. Every notice above was published by the FDA, USDA FSIS or CPSC and links back to its source. Browse the whole archive.