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 Apr 7, 2021
EPIX Therapeutics DiamondTemp Unidirectional Small Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Epix Therapeutics, Inc.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 7, 2021
Vertical Drain Tube Attachment Device (VTAD) (Gastrointestinal tube and accessories) - Product Usage: designed to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hollister Incorporated
FDA (openFDA device enforcement)
Reported Apr 7, 2021
Coronavirus antigen detection test system - Product Usage: intended for the qualitative detection of the nucleocapsid…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.LumiraDx
FDA (openFDA device enforcement)
Reported Apr 7, 2021
Implantable cardioverter defibrillators (ICD): 1) Evera family: Evera XT DR, Evera S DR, Evera MRI XT DR, Evera MRI S…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 7, 2021
Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Perfusion Systems
FDA (openFDA device enforcement)
Reported Apr 7, 2021
PRECICE STRYDE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nuvasive Specialized Orthopedics Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 7, 2021
AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Oscor, Inc.
FDA (openFDA device enforcement)
Reported Apr 7, 2021
Philips SureSigns VM4, VM6 and VM8 - Product Usage: patient monitors-for monitoring, recording and alarming of multiple…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America, LLC
FDA (openFDA device enforcement)
Reported Apr 7, 2021
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
FDA (openFDA device enforcement)
Reported Apr 7, 2021
ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Smisson-Cartledge Biomedical, LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 7, 2021
Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmonic ACE +7, Shears with Advanced Hemostasis…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Sustainability Solutions
FDA (openFDA device enforcement)
Reported Mar 31, 2021
BARD MARQUEE Disposable Core Biopsy Instruments XX.Xcm, XX.Xcm, XXg x XXcm REF XXXXXXX Note - for definition of the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bard Peripheral Vascular Inc.
FDA (openFDA device enforcement)
Reported Mar 31, 2021
Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
3 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 31, 2021
VITEK 2 (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomerieux Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 31, 2021
Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (SMALL) C3, REF: D138501, Rx Only, CE 2797, STERILE…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biosense Webster, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 31, 2021
CAIRE DIAGNOSTICS FenomPro REF 900-0001 SN ***** - Product Usage: a portable, non-invasive device to measure fractional…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Caire Diagnostics Inc.
FDA (openFDA device enforcement)
Reported Mar 31, 2021
In-View Clear Leggings Sterile
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
4 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 31, 2021
Corin BIOLOX DELTA MOD HEAD 32mm EX LONG +7mm 12/14 TAPER. Corin Trinity Acetabular System with Extra Long…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Corin Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 31, 2021
Operating Table System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Getinge Group Logistics America, LLC
FDA (openFDA device enforcement)
Reported Mar 31, 2021
Ultrasonic pulsed doppler imaging system - Product Usage: intended for use by trained personnel (doctor, Sonographer,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hitachi Medical Systems America Inc.
FDA (openFDA device enforcement)
Reported Mar 31, 2021
In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.In2Bones, SAS
FDA (openFDA device enforcement)
Reported Mar 31, 2021
The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in serum - Product Usage: intended to aid in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Meridian Bioscience Inc.
FDA (openFDA device enforcement)
Reported Mar 31, 2021
Mizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA, REF 18-140-20 containing hand control Unit - Product Usage:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mizuho OSI
FDA (openFDA device enforcement)
Reported Mar 31, 2021
Duodenoscope and accessories, flexible/rigid - Product Usage: used with an Olympus video system center, light source,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
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.