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 Mar 26, 2025
Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional accessory for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Remel, Inc.
FDA (openFDA device enforcement)
Reported Mar 26, 2025
smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24
High riskUsing this product could cause serious injury, illness or death — stop using it now.Smiths Medical ASD, Inc.
13 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 26, 2025
Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Waldemar Link GmbH & Co. KG (Mfg Site)
2 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 26, 2025
Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Orthopedics Manfacturing Limited-Galway
FDA (openFDA device enforcement)
Reported Mar 19, 2025
Numerous models of nonsterile hemostatic forceps: (1) REF BJ500R, Phaneuf Hysterectomy Forceps STR 210MM; (2) REF…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aesculap Inc.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 19, 2025
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
FDA (openFDA device enforcement)
Reported Mar 19, 2025
CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation. It is introduced percutaneously in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CardioFocus, Inc.
FDA (openFDA device enforcement)
Reported Mar 19, 2025
BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software
High riskUsing this product could cause serious injury, illness or death — stop using it now.CareFusion 303, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 19, 2025
Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cordis US Corp.
FDA (openFDA device enforcement)
Reported Mar 19, 2025
COR Disposable Kit, 8 mm. Cartilage Transplant System.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Mitek, Inc., a Johnson & Johnson Co.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 19, 2025
GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
6 more products in this recall
FDA (openFDA device enforcement)
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)
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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.