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 5, 2023
Cirq Arm System 2.0
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Brainlab AG
FDA (openFDA device enforcement)
Reported Apr 5, 2023
COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0 mm I.D. The Shiley Lo-Pro Oral/Nasal Tracheal Tube…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien
FDA (openFDA device enforcement)
Reported Apr 5, 2023
DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Defibtech, LLC
FDA (openFDA device enforcement)
Reported Apr 5, 2023
Instructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical Instruments: (1) Part…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Elekta Instrument AB
FDA (openFDA device enforcement)
Reported Apr 5, 2023
PCRopsis BCSNano (1mL), REF 2276001; nucleic acid extraction from a variety of biological samples
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Entopsis , Inc.
6 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 5, 2023
Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fujifilm Irvine Scientific, Inc.
FDA (openFDA device enforcement)
Reported Apr 5, 2023
GaGa Pro Lighting Equipment Co. Ltd. manufactures Class IV Laser Light Show (LLS)projectors for the purposes of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Gaga Pro Lighting Equipment Co.,
FDA (openFDA device enforcement)
Reported Apr 5, 2023
ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Instrumentation Laboratory
3 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 5, 2023
da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
FDA (openFDA device enforcement)
Reported Apr 5, 2023
Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, REF 1057-50,
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Iradimed Corporation
FDA (openFDA device enforcement)
Reported Apr 5, 2023
SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Limacorporate S.p.A
FDA (openFDA device enforcement)
Reported Apr 5, 2023
Neodent GM X 6mm Engaging Titanium Base, REF: 9007162
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Preat Corp.
FDA (openFDA device enforcement)
Reported Apr 5, 2023
MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Quidel Corporation
FDA (openFDA device enforcement)
Reported Apr 5, 2023
CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Randox Laboratories
FDA (openFDA device enforcement)
Reported Apr 5, 2023
ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material #…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
FDA (openFDA device enforcement)
Reported Apr 5, 2023
Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-135; Color Cuff Dual Port, Single…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Sustainability Solutions
FDA (openFDA device enforcement)
Reported Apr 5, 2023
CoCr Femoral Head, XS, 38/-8, Taper 12/14-Intended to be used as a modular head component for articulation in total hip…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
FDA (openFDA device enforcement)
Reported Mar 29, 2023
G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Number 110024462
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
FDA (openFDA device enforcement)
Reported Mar 29, 2023
BD Pyxis Anesthesia ES System (PAS ES), REF: 327; BP Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
FDA (openFDA device enforcement)
Reported Mar 29, 2023
Clariti 1-day toric soft contact lenses, Power -1.00 -1.25/90
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CooperVision, Inc.
FDA (openFDA device enforcement)
Reported Mar 29, 2023
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Datascope Corp.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 29, 2023
Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 29, 2023
DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DeRoyal Industries Inc.
FDA (openFDA device enforcement)
Reported Mar 29, 2023
Raystation treatment planning system for radiation therapy, Model Numbers 9.0.0, 9.0.1, 9.1.0, 9.2.0, 10.0.0, 10.0.1,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
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.