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 Mar 17, 2021
System INFX-8000V
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Canon Medical System, USA, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 17, 2021
VentStar Anesthesia (N) 180 - Drager Breathing Circuits/Anesthesia Sets Order Number: MP00333 - Product Usage:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Draeger Medical, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 17, 2021
Anesthesia gas-machine - Product Usage: intended for use in administering anesthesia while controlling the entire…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Getinge Group Logistics America, LLC
FDA (openFDA device enforcement)
Reported Mar 17, 2021
Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
FDA (openFDA device enforcement)
Reported Mar 17, 2021
Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalog Number: PT 000002 XXX XXX XX PT 000318 PT…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Insulet Corporation
FDA (openFDA device enforcement)
Reported Mar 17, 2021
Power Injectable CT Port insertion kits - Product Usage: is an implantable access device designed to provide repeated…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medical Components, Inc. dba MedComp
FDA (openFDA device enforcement)
Reported Mar 17, 2021
Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesions in the descending thoracic aorta (DTA).
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Vascular, Inc.
FDA (openFDA device enforcement)
Reported Mar 17, 2021
Medtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Model Number: LA6JL35
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Vascular
3 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 17, 2021
Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.OraSure Technologies, Inc.
FDA (openFDA device enforcement)
Reported Mar 17, 2021
PHYSIO CONTROL LIFEPAK CR2 Defibrillator 3321605-xxx The LIFEPAK CR2 defibrillator is designed for indoor and outdoor…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Physio-Control, Inc.
FDA (openFDA device enforcement)
Reported Mar 17, 2021
CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 10mm Material Number: 66-110 - Product Usage: intended for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
40 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 17, 2021
Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: used as an aid in the diagnosis of lipid…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Mar 17, 2021
Thread-like wire marker
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Somatex Medical Technologies GmbH
FDA (openFDA device enforcement)
Reported Mar 17, 2021
SUNSTAR G.U.M. HYDRAL DRY MOUTH RELIEF On-the-go Oral Spray, 2 FL.OZ. UPC0 70942 30713 0 - Product Usage: The device is…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sunstar Americas, Inc.
FDA (openFDA device enforcement)
Reported Mar 17, 2021
Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Thermo Fisher Scientific
FDA (openFDA device enforcement)
Reported Mar 17, 2021
Thyroglobulin Antibody (TgAB) Calibrator - Product Usage: intended for IN VITRO DIAGNOSTIC USE ONLY for the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Tosoh Bioscience Inc.
FDA (openFDA device enforcement)
Reported Mar 10, 2021
ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular Ultrasound Catheter is a component of the ACIST…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Acist Medical Systems
FDA (openFDA device enforcement)
Reported Mar 10, 2021
Barco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGY
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Barco N.V.
FDA (openFDA device enforcement)
Reported Mar 10, 2021
The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
FDA (openFDA device enforcement)
Reported Mar 10, 2021
Gram-Negative Bacteria And Associated Resistance Markers; Film Array Blood Culture Identification (BCID); Film Array…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.BioFire Diagnostics, LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 10, 2021
Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares. Outer box UPN, Inner Pouch UPN:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
2 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 10, 2021
Velocity Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bovie Medical Corporation
2 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 10, 2021
Milex Gellhorn Flexible under the following labels: 1) Gellhorn Flexible w/Short Stem Pessary, REF MXKPGSS2-1/4, 2-1/4"…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CooperSurgical, Inc.
FDA (openFDA device enforcement)
Reported Mar 10, 2021
Band, Elastic, Orthodontic - Product Usage: Orthodontic elastics, also referred to as rubber bands, are small stretchy…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.G & H Wire Company
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.