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 31, 2021
VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only). Used to calibrate VITROS 250/350/5,1…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Mar 31, 2021
RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information system that supports healthcare…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
FDA (openFDA device enforcement)
Reported Mar 31, 2021
Interventional Fluoroscopic X-Ray System - Product Usage: developed for single and biplane diagnostic imaging and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
FDA (openFDA device enforcement)
Reported Mar 31, 2021
S-Series Equipment Management System; Model Number(s):0682400550; UDI: 07613327400502 Components that are affected…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Communications
FDA (openFDA device enforcement)
Reported Mar 31, 2021
RUSCH¿ POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 24, 2021
CyberKnife Treatment Delivery System - Product Usage: indicated for image-guided stereotactic radiosurgery and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Accuray Incorporated
FDA (openFDA device enforcement)
Reported Mar 24, 2021
Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V Catheterization Table CAT-880B Canon CATHETERIZATION TABLE,…
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 24, 2021
Magellan Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm). A single lumen needle intended to inject fluids…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
3 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 24, 2021
Carestream Dental CS 3600 Single Use Normal Tips, Catalog Number 5941216 - Product Usage: used to record the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Carestream Dental, LLC
FDA (openFDA device enforcement)
Reported Mar 24, 2021
PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC, PC0630RXC,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Cordis Corporation
FDA (openFDA device enforcement)
Reported Mar 24, 2021
Feth-R-Kath Catheter, 19g x 24". Intended Use:Radlo Opaque Epidural Catheter Catalog #: 157-1924 Intended for epidural…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Epimed International, Inc.
FDA (openFDA device enforcement)
Reported Mar 24, 2021
Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Imactis
FDA (openFDA device enforcement)
Reported Mar 24, 2021
RNA MEDICAL, QCHGB HEMOGLOBIN CONTROL, MULTI, REF QC HGB - Product Usage: monitoring the performance of Hemocue…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medline Industries Inc.
FDA (openFDA device enforcement)
Reported Mar 24, 2021
Medtronic Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENATOR…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Perfusion Systems
9 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 24, 2021
HeartSpan Transseptal Needles Catalog No. FND-019-01, Lot No. E1913644 consisting of an outer needle cannula and an…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merit Medical Systems, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 24, 2021
Mindray BeneVision Distributed Monitoring System( DMS) 1. p/n 115-051209-00 2. p/n 115-034414-00 and 115-034413-00 when…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mindray DS USA, Inc. dba Mindray North America
FDA (openFDA device enforcement)
Reported Mar 24, 2021
VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent- In Vitro Diagnostic. The VITROS Immunodiagnostic Products…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 24, 2021
Philips CT systems are advanced continuous-rotation computed tomography systems suitable for a wide range of computed…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Healthcare (Suzhou) Co., Ltd.
FDA (openFDA device enforcement)
Reported Mar 24, 2021
Incisive CT Computed Tomography X-ray System Model: 728143
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
FDA (openFDA device enforcement)
Reported Mar 24, 2021
Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit (sTfR immunological test system)). An enzyme linked…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.R & D Systems, Inc.
FDA (openFDA device enforcement)
Reported Mar 24, 2021
Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Mar 24, 2021
Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a in the Computed tomography systems as follows: SOMATOM…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
FDA (openFDA device enforcement)
Reported Mar 24, 2021
SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sirtex Medical Limited
FDA (openFDA device enforcement)
Reported Mar 17, 2021
ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Brainlab AG
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.