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 Feb 25, 2026
Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the abdominal cavity, and automatic…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Olympus Corporation of the Americas
14 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 25, 2026
MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN):…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
FDA (openFDA device enforcement)
Reported Feb 25, 2026
Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 REF:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wilson-Cook Medical Inc.
FDA (openFDA device enforcement)
Reported Feb 18, 2026
ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N UDI-DI code: 00190376476179;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alphatec Spine, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 18, 2026
Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.AVID Medical, Inc.
FDA (openFDA device enforcement)
Reported Feb 18, 2026
Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11.1 Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Elekta, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 18, 2026
Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hologic, Inc.
FDA (openFDA device enforcement)
Reported Feb 18, 2026
da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
FDA (openFDA device enforcement)
Reported Feb 18, 2026
Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4, 800 ml, RTCA; Catalog Number: 880052; 2) LCSU 4,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Laerdal Medical Corporation
FDA (openFDA device enforcement)
Reported Feb 18, 2026
Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medline Industries, LP
19 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 18, 2026
Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
7 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 18, 2026
Brilliance iCT; Product Code (REF): 728306;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
3 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 18, 2026
Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
FDA (openFDA device enforcement)
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)
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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.