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 Jan 29, 2025
DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 29, 2025
Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Microvention Inc.
FDA (openFDA device enforcement)
Reported Jan 29, 2025
Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.O&m Halyard, Inc.
FDA (openFDA device enforcement)
Reported Jan 29, 2025
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm, 35 cm,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
10 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 29, 2025
Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 29, 2025
VDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK, Phasitron Kit, VDR, Single…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Percussionaire Corporation
FDA (openFDA device enforcement)
Reported Jan 29, 2025
Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Randox Laboratories, Limited
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 29, 2025
Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interfaces with CardioMEMS"…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.St. Jude Medical
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 29, 2025
The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used to cut bone and bone cement during…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 29, 2025
Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD Model/Catalog Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Trinity Sterile, Inc.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 22, 2025
McKesson Cardiology Hemo software
Moderate riskThis product could cause temporary or reversible health problems — stop using it.A L I Technologies Ltd.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 22, 2025
Impella RP with SmartAssist; Product Number: 0046-0035;
High riskUsing this product could cause serious injury, illness or death — stop using it now.Abiomed, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 22, 2025
VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Accriva Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Jan 22, 2025
Brand Name: Alcon Product Name: Monarch¿ III D Delivery Cartridge Model/Catalog Number: 8065977763 Product Description:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alcon Research LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 22, 2025
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model #…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Augustine Temperature Management, LLC
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 22, 2025
Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 22, 2025
Idylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic acid targets in various types of human…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biocartis Nv
FDA (openFDA device enforcement)
Reported Jan 22, 2025
ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Boston Scientific Corporation
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 22, 2025
Cardinal Health Presource Kits: 1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951; 2) KIT,ORP PLASTIC FLAP,Catalog Number…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
9 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 22, 2025
BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Med ES Main Tower), REF: 352
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
FDA (openFDA device enforcement)
Reported Jan 22, 2025
Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Coloplast Manufacturing US, LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 22, 2025
Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy system consisting of an…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ConvaTec, Inc.
FDA (openFDA device enforcement)
Reported Jan 22, 2025
Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Biotech, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 22, 2025
DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DRG International, Inc.
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.