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 1, 2023
Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiovascular, LLC
FDA (openFDA device enforcement)
Reported Nov 1, 2023
Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone Matrix
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
6 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 1, 2023
Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Omega Medical Imaging, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 1, 2023
Preat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Preat Corp.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 1, 2023
Astral 100 and Astral 150 ventilators
High riskUsing this product could cause serious injury, illness or death — stop using it now.ResMed Ltd.
FDA (openFDA device enforcement)
Reported Nov 1, 2023
JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis
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 Nov 1, 2023
Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
FDA (openFDA device enforcement)
Reported Nov 1, 2023
SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
Moderate riskThis product could cause temporary or reversible health problems — stop using it.SynCardia Systems LLC
FDA (openFDA device enforcement)
Reported Nov 1, 2023
One Step Pregnancy Test REF 100-01
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Universal Meditech Inc.
26 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 25, 2023
HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Access Vascular, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 25, 2023
Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
FDA (openFDA device enforcement)
Reported Oct 25, 2023
DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DeRoyal Industries Inc.
FDA (openFDA device enforcement)
Reported Oct 25, 2023
Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Eitan Medical Ltd.
FDA (openFDA device enforcement)
Reported Oct 25, 2023
MEDLINE ReNewal Ligasure Blunt Tip Sealer/Divider Nano-Coated Compatible with FT10 Generator, REF LF1844CR.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
3 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 25, 2023
SenSight Connector Plug, Model Number B31061.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
FDA (openFDA device enforcement)
Reported Oct 25, 2023
Gladiator, Wrist & Thumb Orthosis, Part Numbers: NC86650 (Small/Left), NC86651 (Small/Right), NC86652 (Medium/Left),…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.North Coast Medical Inc.
FDA (openFDA device enforcement)
Reported Oct 25, 2023
Functional MR V1.0
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olea Medical
FDA (openFDA device enforcement)
Reported Oct 25, 2023
Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.
High riskUsing this product could cause serious injury, illness or death — stop using it now.Olympus Corporation of the Americas
FDA (openFDA device enforcement)
Reported Oct 25, 2023
stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Tornier, Inc.
FDA (openFDA device enforcement)
Reported Oct 18, 2023
MED-810A Zemits NDPrime Laser products
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Advance-Esthetic LLC
FDA (openFDA device enforcement)
Reported Oct 18, 2023
Constellation Vision System, REF: 8065751150
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alcon Research, LLC
FDA (openFDA device enforcement)
Reported Oct 18, 2023
GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ansell Healthcare Products LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 18, 2023
Access Thyroglobulin Calibrators
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 18, 2023
BD BACTEC Plus Aerobic/F Culture Vials, Catalog Number 442023
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
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.