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 Feb 1, 2023
Baxter Electrocardiograph, ELI 380 -DCS21
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
FDA (openFDA device enforcement)
Reported Feb 1, 2023
biokitHSV-2 Rapid Test, REF: 300028001
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biokit, S.A.
FDA (openFDA device enforcement)
Reported Feb 1, 2023
Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a knee joint when used in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
FDA (openFDA device enforcement)
Reported Feb 1, 2023
MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Contact Lens (daily wear). Single Use.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CooperVision, Inc.
FDA (openFDA device enforcement)
Reported Feb 1, 2023
Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Future Diagnostics Solutions B.V.
FDA (openFDA device enforcement)
Reported Feb 1, 2023
Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part no. 6677400
High riskUsing this product could cause serious injury, illness or death — stop using it now.Getinge USA Sales Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 1, 2023
Veritas Advanced Infusion Packs, REF: VRT-AI
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Johnson & Johnson Surgical Vision, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 1, 2023
CENTURION MEDICAL PRODUCTS, SILVER ANTIMICROBIAL VAD DRIVE, REF DT18760
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
FDA (openFDA device enforcement)
Reported Feb 1, 2023
Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Meridian Bioscience Inc.
FDA (openFDA device enforcement)
Reported Feb 1, 2023
Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow license, or myNeedle Guide 3D license. Used…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
FDA (openFDA device enforcement)
Reported Feb 1, 2023
Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size REF Number 0.0 50005 0.5 50055 1.0 50105 1.5 50155 2.0…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.SunMed Holdings, LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 1, 2023
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal. Intended for patients requiring endotracheal intubation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 25, 2023
Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Abbott Laboratories
FDA (openFDA device enforcement)
Reported Jan 25, 2023
RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bolton Medical Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 25, 2023
SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFESPARC, CONTROLLER ONLY - 5900-0001.…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Cardiac Assist, Inc.
FDA (openFDA device enforcement)
Reported Jan 25, 2023
Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2186
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
27 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 25, 2023
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Datascope Corp.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 25, 2023
Hemopro 2 with Vasoshield, Model VH-4001
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiovascular, LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 25, 2023
MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mobius Imaging, LLC
FDA (openFDA device enforcement)
Reported Jan 25, 2023
R&D CBC-3D Hematology Control: (1) CBC-3D Normal Pack Hematology Control, REF 3D501, containing 10 x 2.0mL Control N;…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.R & D Systems, Inc.
FDA (openFDA device enforcement)
Reported Jan 25, 2023
ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 18, 2023
Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile Catalog number: INT CSS…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bayer Medical Care, Inc.
FDA (openFDA device enforcement)
Reported Jan 18, 2023
BD Pyxis MedBank System - Product Label/labeling pending
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
FDA (openFDA device enforcement)
Reported Jan 18, 2023
CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CoreLink LLC
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.