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 18, 2026
WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Straumann USA LLC
FDA (openFDA device enforcement)
Reported Feb 18, 2026
Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Surepulse Medical Ltd.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 11, 2026
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 11, 2026
VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomerieux Inc.
FDA (openFDA device enforcement)
Reported Feb 11, 2026
AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number (UPN): M00553660;
High riskUsing this product could cause serious injury, illness or death — stop using it now.Boston Scientific Corporation
5 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 11, 2026
LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER REAGENT STRIPS; Vaunn Medical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Changchun Wancheng Bio-Electron Co., Ltd.
10 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 11, 2026
EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Encore Medical, LP
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 11, 2026
Brand Name: Molift Product Name: Molift Mover 205 Model/Catalog Number: (1) M14000, (2) M1401, (3) M1402, (4) M14050,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Etac A/s
3 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 11, 2026
Focalyx Fusion
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Focalyx Technologies, LLC.
FDA (openFDA device enforcement)
Reported Feb 11, 2026
FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.FUJIFILM Healthcare Americas Corporation
FDA (openFDA device enforcement)
Reported Feb 11, 2026
Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number: CL0073 Software Version: Not…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fujirebio Diagnostics, Inc.
6 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 11, 2026
Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
FDA (openFDA device enforcement)
Reported Feb 11, 2026
Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiopulmonary GmbH
FDA (openFDA device enforcement)
Reported Feb 11, 2026
MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The MiniMed 780G insulin pump…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed, Inc.
FDA (openFDA device enforcement)
Reported Feb 11, 2026
Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
31 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 11, 2026
SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
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 Feb 11, 2026
TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Tornier, Inc.
FDA (openFDA device enforcement)
Reported Feb 11, 2026
PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Vantive US Healthcare LLC
7 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 11, 2026
Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying Lens, Catalog VMD
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Vortex Surgical Inc.
12 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 11, 2026
Product Name: Nasal Jejunal Feeding Tube REF: NJFT-10
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wilson-Cook Medical Inc.
FDA (openFDA device enforcement)
Reported Feb 4, 2026
Fixone Hybrid Anchor
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aju Pharm Co., Ltd.
7 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 4, 2026
Alphenix INFX-8000C, interventional fluoroscopic x-ray system
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Canon Medical System, USA, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 4, 2026
Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
FDA (openFDA device enforcement)
Reported Feb 4, 2026
BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardrails" Suite MX is a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
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.