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 Mar 19, 2025
Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number: 380730 Software…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
FDA (openFDA device enforcement)
Reported Mar 19, 2025
Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014 AR…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Perfusion Systems
FDA (openFDA device enforcement)
Reported Mar 19, 2025
Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.V.
FDA (openFDA device enforcement)
Reported Mar 19, 2025
Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Smiths Medical ASD, Inc.
FDA (openFDA device enforcement)
Reported Mar 19, 2025
Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors Product Name: Pump, Blood,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Spectrum Medical Inc.
FDA (openFDA device enforcement)
Reported Mar 19, 2025
Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE 0197
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
FDA (openFDA device enforcement)
Reported Mar 19, 2025
Brand Name: TruScan Body, REF CN38-SB Product Name: TruScan Body compatible with CONELOG 3.8 Model/Catalog Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.TruAbutment Inc.
FDA (openFDA device enforcement)
Reported Mar 19, 2025
Z1 Femoral Hip System, Product Number 611777612
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
FDA (openFDA device enforcement)
Reported Mar 19, 2025
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-00A, (2) G5A-01A, (3) G5A-02A, (4)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ZOLL Medical Corporation
7 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 12, 2025
Alcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17, 12698-09, 15632-10, 3141-45, 12630-07,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alcon Research LLC
FDA (openFDA device enforcement)
Reported Mar 12, 2025
Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF:…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Bard Peripheral Vascular Inc.
FDA (openFDA device enforcement)
Reported Mar 12, 2025
Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 12, 2025
Access Erythropoietin (EPO), Catalog Number - A16364 a glycoprotein (~30,400 Daltons) produced primarily by the kidney,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
FDA (openFDA device enforcement)
Reported Mar 12, 2025
BD BBL TB Stain Kit K, Catalog (REF): 212522
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
FDA (openFDA device enforcement)
Reported Mar 12, 2025
VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is indicated for use in catheter based…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Biosense Webster, Inc.
FDA (openFDA device enforcement)
Reported Mar 12, 2025
DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suction, Connector; DeRoyal REF…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DeRoyal Industries Inc.
FDA (openFDA device enforcement)
Reported Mar 12, 2025
ET Rigid Abutment (Mini) Size 4.5D 1.0G/H 5.0H - Intended for use with a dental implant to provide support for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hiossen Inc.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 12, 2025
human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Human Med Ag
FDA (openFDA device enforcement)
Reported Mar 12, 2025
AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
FDA (openFDA device enforcement)
Reported Mar 12, 2025
CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Kung Shin Plastics Co. Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 12, 2025
(1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pulse 120H, Moses 2.0 (DOM), REF GA0006802,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Lumenis, Ltd.
FDA (openFDA device enforcement)
Reported Mar 12, 2025
Brand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number: TBS iNsight v3.x / pn: OS-TBSi Software Version:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medimaps Group
FDA (openFDA device enforcement)
Reported Mar 12, 2025
Paradigm REF: MMT-712 and MMT-715
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed, Inc.
11 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 12, 2025
Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Micro Therapeutics, Inc.
1 more product 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.