Category

Medical Devices Recalls

15,654 medical devices recalls on record from CPSC, FDA, and USDA.

15,654 recalls
High RiskFDA
Ge Medical Systems, Llc
SIGNA Architect AIR
Medical Devices·0 affected·May 23, 2025
High RiskFDA
Jewel Precision Sheet Metal & Machining Co, Inc.
Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.
Medical Devices·1 affected·May 23, 2025
High RiskFDA
Change Healthcare Canada Company
Change Healthcare Cardiology Hemodynamics Software
Medical Devices·4 affected·May 22, 2025
CriticalFDA
Integra Lifesciences Corp. (neurosciences)
Extended Tip Applicator, 15 CM, Box of 5.
Medical Devices·2,524 affected·May 22, 2025
High RiskFDA
Stryker Gmbh
Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S.
Medical Devices·1 affected·May 22, 2025
CriticalFDA
Integra Lifesciences Corp. (neurosciences)
Extended Tip Applicator, 8CM, Box of 5.
Medical Devices·6,216 affected·May 22, 2025
High RiskFDA
Change Healthcare Canada Company
Change Healthcare Cardiology Hemo Software
Medical Devices·29 affected·May 22, 2025
High RiskFDA
Becton Dickinson & Co.
BD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinam...
Medical Devices·12,256 affected·May 20, 2025
High RiskFDA
Onkos Surgical, Inc.
My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplast...
Medical Devices·1 affected·May 20, 2025
High RiskFDA
Limacorporate S.p.a
PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile
Medical Devices·9 affected·May 19, 2025
High RiskFDA
Drs Vascular, Inc
Brand Name: Q-Stop Product Name: Suture Retention Device Model/Catalog Number: QS Software Version: N/A Product Description: The DRS Vasc...
Medical Devices·264 affected·May 16, 2025
High RiskFDA
Therakos Development Limited
Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Number: CLXUSA Software Version: Not Appl...
Medical Devices·5,826 affected·May 16, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250
Medical Devices·174 affected·May 15, 2025
High RiskFDA
Contamac Solutions, Inc.
Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution
Medical Devices·17,273 affected·May 15, 2025
High RiskFDA
Siemens Medical Solutions Usa, Inc
interventional fluoroscopic x-ray system
Medical Devices·0 affected·May 15, 2025
High RiskFDA
Siemens Medical Solutions Usa, Inc
interventional fluoroscopic x-ray system
Medical Devices·0 affected·May 15, 2025
CriticalFDA
Sunmed Holdings, Llc
Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife brand, 2025 Edition, and 36-23446 Rev 2 Prin...
Medical Devices·9,900 affected·May 15, 2025
High RiskFDA
Siemens Medical Solutions Usa, Inc
interventional fluoroscopic x-ray system
Medical Devices·0 affected·May 15, 2025
CriticalFDA
Edwards Lifesciences, Llc
Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software Version: N/A Product Descrip...
Medical Devices·847 affected·May 14, 2025
CriticalFDA
Edwards Lifesciences, Llc
Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A Software Version: N/A Product Descript...
Medical Devices·13,240 affected·May 14, 2025
High RiskFDA
Philips North America Llc
Product Name: Evolution Upgrade 3.0T; Model Numbers: (1) 782117, (2) 782143;
Medical Devices·28 affected·May 13, 2025
High RiskFDA
Philips North America Llc
Product Name: Ingenia 3.0T CX; Model Number: 781271;
Medical Devices·37 affected·May 13, 2025
High RiskFDA
Philips North America Llc
Product Name: Ingenia 1.5T CX; Model Number: 781262;
Medical Devices·9 affected·May 13, 2025
High RiskFDA
Philips North America Llc
Product Name: MR 7700; Model Numbers: (1) 782120, (2) 782153;
Medical Devices·72 affected·May 13, 2025
High RiskFDA
Spectral Instruments Inc
Ami HTX.
Medical Devices·34 affected·May 13, 2025
High RiskFDA
Cardinal Health 200, Llc
SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
Medical Devices·6,517 affected·May 13, 2025
High RiskFDA
Philips North America Llc
Product Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) 782136;
Medical Devices·198 affected·May 13, 2025
High RiskFDA
Philips North America Llc
Product Name: Ingenia 3.0T; Model Numbers: (1) 781342, (2) 781377, (3) 782103;
Medical Devices·193 affected·May 13, 2025
High RiskFDA
Philips North America Llc
Product Name: Ingenia 1.5T S; Model Number: 781347;
Medical Devices·2 affected·May 13, 2025
High RiskFDA
Philips North America Llc
Product Name: SmartPath to dStream for 3.0T; Model Number: 782145
Medical Devices·12 affected·May 13, 2025
High RiskFDA
Philips North America Llc
Product Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3) 782138;
Medical Devices·300 affected·May 13, 2025
High RiskFDA
Philips North America Llc
Product Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) 782137;
Medical Devices·65 affected·May 13, 2025
High RiskFDA
Spectral Instruments Inc
Lago X
Medical Devices·39 affected·May 13, 2025
High RiskFDA
Philips North America Llc
Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2) 782144;
Medical Devices·16 affected·May 13, 2025
High RiskFDA
Cardinal Health 200, Llc
Kendall SCD Blended Comfort Sleeves Knee Length Small - For use with Kendall SCD SmartFlow SKU 84021B Kendall SCD Small Comfort ...
Medical Devices·6,517 affected·May 13, 2025
High RiskFDA
Philips North America Llc
Product Name: Ingenia Ambition S; Model Numbers: (1) 781359, (2) 782108, (3) 782139;
Medical Devices·152 affected·May 13, 2025
CriticalFDA
Fresenius Kabi Usa, Llc
IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administ...
Medical Devices·14,280 affected·May 12, 2025
High RiskFDA
Bd Switzerland Sarl
BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500
Medical Devices·1,655,300 affected·May 12, 2025
High RiskFDA
Bd Switzerland Sarl
BD Texium Needle-Free Syringe: 3 mL, REF: MY8003; 5 mL, REF: MY8005; 10 mL, REF: MY8010; 20 mL, REF: MY8020; 30 mL, REF: MY8030; 60 mL, R...
Medical Devices·1,265,400 affected·May 12, 2025
High RiskFDA
Baxter Healthcare Corporation
Baxter Novum IQ Syringe Pump, product code 40800BAXUS,
Medical Devices·8,027 affected·May 12, 2025
High RiskFDA
Bd Switzerland Sarl
BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241; BD TEXIUM (China), REF: 10012241 CHINA
Medical Devices·1,006,512 affected·May 12, 2025
High RiskFDA
Bd Switzerland Sarl
Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back Check Valve 2 SmartSite Y-Sites, REF: 1001...
Medical Devices·2,024,780 affected·May 12, 2025
CriticalFDA
Baxter Healthcare Corporation
2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope handles, Product Code 72600
Medical Devices·277 affected·May 9, 2025
High RiskFDA
Carefusion 303, Inc.
Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD Pyxis Logistics [806], BD Pyxis MedStation 4000 Main 10885403...
Medical Devices·6,332 affected·May 8, 2025
High RiskFDA
Medtronic Minimed, Inc.
Medtronic, Simplera Sensor, REF: MMT-5100JD1
Medical Devices·1,440 affected·May 7, 2025
High RiskFDA
Natus Neurology Dba Excel Tech., Ltd. (xltek)
Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition Box) Model/Catalog Number: O...
Medical Devices·3,069 affected·May 7, 2025
CriticalFDA
Zyno Medical Llc
Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Medical Devices·613 affected·May 7, 2025
High RiskFDA
Microaire Surgical Instruments, Llc
Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alternate name: ECTR (Endoscopic Carpal...
Medical Devices·1,451 affected·May 7, 2025