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 Nov 26, 2025
Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Greiner Bio-One North America, Inc.
FDA (openFDA device enforcement)
Reported Nov 26, 2025
MEDLINE STERILE BASIC EYE PACK 16: 1) REF: DYNJ37743D; 2) REF: DYNJ37743F.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medline Industries, LP
20 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 26, 2025
MC3 VitalFlow Console, REF 58100; Blood pump of ecmo
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 26, 2025
Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Meridian Bioscience Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 26, 2025
PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merit Medical Systems, Inc.
FDA (openFDA device enforcement)
Reported Nov 26, 2025
Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
FDA (openFDA device enforcement)
Reported Nov 26, 2025
OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor FOBT (Fecal Occult…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Polymedco, Inc. / Polymedco Cancer Diagnostic Products, LLC
FDA (openFDA device enforcement)
Reported Nov 26, 2025
Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant Assay Model/Catalog Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Quest International, Inc.
FDA (openFDA device enforcement)
Reported Nov 26, 2025
Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Product Name: CATHETER…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sterilmed, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 26, 2025
Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Thoratec LLC
3 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 26, 2025
TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
High riskUsing this product could cause serious injury, illness or death — stop using it now.TMJ Solutions Inc.
FDA (openFDA device enforcement)
Reported Nov 19, 2025
Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
FDA (openFDA device enforcement)
Reported Nov 19, 2025
Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Medical
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 19, 2025
VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole blood…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Accriva Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Nov 19, 2025
Applied Medical Technology, Inc., NutraGlide, 5 f - 6F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-05055-I
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Applied Medical Technology Inc.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 19, 2025
BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
FDA (openFDA device enforcement)
Reported Nov 19, 2025
CEREPAK Detachable Coil System - Name/REF: UNIFORM 2MM X 2.5 CM/FCX100202, UNIFORM 2.5MM X 3.3 CM/FCX100253, UNIFORM…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Cerenovus Inc.
FDA (openFDA device enforcement)
Reported Nov 19, 2025
Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien, LP
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 19, 2025
Carescape B450, Model no. 5805686 - shipped with potentially affected batteries or affected batteries installed as a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare Finland Oy
4 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 19, 2025
Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; Product description/Product numbers:…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medline Industries, LP
20 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 19, 2025
Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
FDA (openFDA device enforcement)
Reported Nov 19, 2025
BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Miach Orthopaedics
FDA (openFDA device enforcement)
Reported Nov 19, 2025
GM85 Digital Mobile X-ray imaging System; Model Number: GM85;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.NeuroLogica Corporation
FDA (openFDA device enforcement)
Reported Nov 19, 2025
Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number: SPL-T…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
2 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.