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 Aug 30, 2023
IMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10122810, d) B242C11062810, e) B242C11122810, f)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medicrea International
10 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 30, 2023
The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.-Littleton
FDA (openFDA device enforcement)
Reported Aug 30, 2023
The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
FDA (openFDA device enforcement)
Reported Aug 30, 2023
Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in the quality control of Amylase, Calcium,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Randox Laboratories Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 30, 2023
ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151, in vitro diagnostic use in the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Aug 30, 2023
TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 23, 2023
FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Diabetes Care, Inc.
FDA (openFDA device enforcement)
Reported Aug 23, 2023
Constellation Procedure Pak
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alcon Research, Ltd.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 23, 2023
Snowden-Pencer MIS DIAMOND-TOUCH GRASPER MCKERNAN FUNDUS 5MM, 32CM, RATCHETED, REF SP90-7012; endoscopic surgical device
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Carefusion 2200 Inc.
14 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 23, 2023
CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Conformis, Inc.
FDA (openFDA device enforcement)
Reported Aug 23, 2023
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, IC Tray REF:8888101001HP
High riskUsing this product could cause serious injury, illness or death — stop using it now.Covidien LP
24 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 23, 2023
Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular Catheter,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neurosurgery
FDA (openFDA device enforcement)
Reported Aug 23, 2023
UroPass Ureteral Access Sheaths, 5 pieces/box
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 16, 2023
INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLE
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Canon Medical System, USA, Inc.
FDA (openFDA device enforcement)
Reported Aug 16, 2023
ellacor System with Micro-Coring Technology-Indicated for use by medical professionals for the treatment of moderate…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cytrellis Biosystems, Inc.
FDA (openFDA device enforcement)
Reported Aug 16, 2023
Total Hip Kit, REF DYNJ903275S; surgical convenience kit
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
FDA (openFDA device enforcement)
Reported Aug 16, 2023
Medtronic InterStim Ground Pad REF 041826
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
FDA (openFDA device enforcement)
Reported Aug 16, 2023
CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA, Inc.
FDA (openFDA device enforcement)
Reported Aug 16, 2023
VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V- For airway management which includes endoscopic observation to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
4 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 16, 2023
VITROS Immunodiagnostic Products Troponin I ES Reagent Pack
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 16, 2023
Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America
5 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 16, 2023
Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Randox Laboratories Ltd.
FDA (openFDA device enforcement)
Reported Aug 16, 2023
UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift¿ system. Instrument for insertion of a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Scholly Fiberoptic GmbH
FDA (openFDA device enforcement)
Reported Aug 16, 2023
ARTIS icono biplane -Angiography systems developed for single and biplane diagnostic imaging and interventional…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, 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.