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 31, 2024
Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 31, 2024
Bard Nasogastric Sump Tube with ENFit, 10Fr., 36in Long, REF EN0042100
Moderate riskThis product could cause temporary or reversible health problems — stop using it.C.R. Bard Inc.
16 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 31, 2024
DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Diasorin Inc.
FDA (openFDA device enforcement)
Reported Jan 31, 2024
PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic acid testing system which fully…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hologic, Inc.
FDA (openFDA device enforcement)
Reported Jan 31, 2024
Snapshot NIR, REF: KD204
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Kent Imaging, Inc.
FDA (openFDA device enforcement)
Reported Jan 31, 2024
Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
FDA (openFDA device enforcement)
Reported Jan 31, 2024
Model A710 Intellis Clinician Programmer Application, version 2.0.97
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
FDA (openFDA device enforcement)
Reported Jan 31, 2024
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Jan 31, 2024
Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ossur H / F
FDA (openFDA device enforcement)
Reported Jan 31, 2024
EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Phadia Ab
FDA (openFDA device enforcement)
Reported Jan 31, 2024
Achieva 1.5T, Model No. 781178, 781196, 781296
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Philips North America
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 31, 2024
Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal swivel arm. It…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sedecal Sa
FDA (openFDA device enforcement)
Reported Jan 31, 2024
TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.St. Jude Medical, Atrial Fibrillation Division, Inc.
FDA (openFDA device enforcement)
Reported Jan 31, 2024
Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ001, L: 7mm, Cementless Sterile.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Tornier, Inc.
FDA (openFDA device enforcement)
Reported Jan 31, 2024
REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S.
FDA (openFDA device enforcement)
Reported Jan 24, 2024
FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Diabetes Care, Inc.
FDA (openFDA device enforcement)
Reported Jan 24, 2024
PosiFlush Prefilled Saline Syringe with General Pump Compatibility (10mL Syringe with 10mL Saline Fill), Catalog Number…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
FDA (openFDA device enforcement)
Reported Jan 24, 2024
CardinalHealth Suction Canister Liner, MEDI-VAC CRD, REF 65651-510
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 24, 2024
MINC+ Benchtop Incubator, Reference Part Number (RPN) K-MINC-2000, Order Number (GPN) G44429
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Medical LLC
FDA (openFDA device enforcement)
Reported Jan 24, 2024
Maquet PowerLEDII OR Light System, Model Names and Catalog Numbers PWDII77SF - ARDPWT629100A, PWDII555DF -…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Getinge USA Sales Inc.
14 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 24, 2024
ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100
High riskUsing this product could cause serious injury, illness or death — stop using it now.Globus Medical, Inc.
FDA (openFDA device enforcement)
Reported Jan 24, 2024
VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Greiner Bio-One North America, Inc.
FDA (openFDA device enforcement)
Reported Jan 24, 2024
TECNIS Toric II OptiBlue IOL Models ZCW
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Johnson & Johnson Surgical Vision, Inc.
FDA (openFDA device enforcement)
Reported Jan 24, 2024
PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code: BASEPLATE D.25MM…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Limacorporate S.p.A
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.