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.
13,791 stored notices, reported between Jun 20, 2012 and Oct 28, 2026. Newest first.
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)
Reported Jan 24, 2024
Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection
High riskUsing this product could cause serious injury, illness or death — stop using it now.Maquet Cardiovascular, LLC
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 24, 2024
Ultrasound EA (Ergonomic Advantage) table versions; G2 (GENERAL 2) -An Ultrasound examination table
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Oakworks Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 24, 2024
Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 24, 2024
High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123
High riskUsing this product could cause serious injury, illness or death — stop using it now.Percussionaire Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 24, 2024
INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Phase Scientific International Limited
FDA (openFDA device enforcement)
Reported Jan 24, 2024
Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
FDA (openFDA device enforcement)
Reported Jan 24, 2024
Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System PIM cable part number 459801179871
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 24, 2024
Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Randox Laboratories Ltd.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 24, 2024
regard Operative LAP, Item Number 800943001; surgical convenience kit
High riskUsing this product could cause serious injury, illness or death — stop using it now.ROi CPS LLC
FDA (openFDA device enforcement)
Reported Jan 24, 2024
Curaplex Field Cric Kit with ET Tube, Item Number 36611. The kit provides healthcare professionals with an assortment…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sarnova HC, LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 24, 2024
Medex LOGICAL CATH LAB KIT, List Number M20754
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical Asd Inc.
8 more products in this recall
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.