Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Waismed Ltd.
Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000603 Software Version: N/A Product Descripti...
Medical Devices·7,056 affected·Jun 5, 2025
High RiskFDA
Merit Medical Systems, Inc.
Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-13342AP, K09-13391BP,...
Medical Devices·6,327 affected·Jun 5, 2025
High RiskFDA
Merit Medical Systems, Inc.
Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029
Medical Devices·2,779 affected·Jun 5, 2025
RecallFDA
Diversatek Healthcare
Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10
Medical Devices·8 affected·Jun 4, 2025
CriticalFDA
Siemens Medical Solutions Usa, Inc
UROSKOP Omnia Max. Model Number: 10762473
Medical Devices·25 affected·Jun 4, 2025
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)
Medical Devices·3,266 affected·Jun 4, 2025
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)
Medical Devices·3,435 affected·Jun 4, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Azurion 7 M20. Fluoroscopic X-Ray System.
Medical Devices·78 affected·Jun 4, 2025
High RiskFDA
Becton, Dickinson And Company, Bd Bio Sciences
REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cytometry for fluorescence compensation.
Medical Devices·278 affected·Jun 3, 2025
High RiskFDA
Icu Medical, Inc.
SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-2000
Medical Devices·1,445,600 affected·Jun 3, 2025
High RiskFDA
C.r. Bard Inc
REF: 123400,Bard Urologist's Tray, For the Obstructed Urethra
Medical Devices·63 affected·Jun 3, 2025
CriticalFDA
Given Imaging Ltd.
Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric gu...
Medical Devices·128,202 affected·Jun 3, 2025
High RiskFDA
C.r. Bard Inc
BD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110, 12Fr - REF:21112, 14Fr - REF: 21114, 20Fr - REF: 21120
Medical Devices·0 affected·Jun 3, 2025
High RiskFDA
Encore Medical, Lp
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE Model/Catalog Number: 341-12-711 So...
Medical Devices·20 affected·Jun 2, 2025
High RiskFDA
Medshape, Inc.
Medshape Universal Joints, REF: DNE-9000-UJ
Medical Devices·849 affected·Jun 2, 2025
High RiskFDA
Encore Medical, Lp
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 10MM, VE Model/Catalog Number: 341-10-711 So...
Medical Devices·20 affected·Jun 2, 2025
High RiskFDA
Philips North America Llc
Spectral CT. Computed tomography X-ray system.
Medical Devices·370 affected·May 29, 2025
CriticalFDA
Philips North America
Intera 1.5T Achieva Nova-Dual Product Number: 781173;
Medical Devices·3 affected·May 29, 2025
CriticalFDA
Philips North America
Intera 1.5T Explorer/Nova Dual Product Number: 781108;
Medical Devices·1 affected·May 29, 2025
CriticalFDA
Philips North America
SmartPath to dStream for 1.5T¿; Product Number: 782146;
Medical Devices·1 affected·May 29, 2025
CriticalFDA
Philips North America
Intera 1.5T Achieva IT Nova Product Number: 781175
Medical Devices·1 affected·May 29, 2025
High RiskFDA
Philips Ultrasound, Inc
Philips eL18-4 EMT Transducer.
Medical Devices·5,230 affected·May 28, 2025
High RiskFDA
Encore Medical, Lp
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm Model/Catalog Number: 506-04-126 Software Vers...
Medical Devices·400 affected·May 28, 2025
High RiskFDA
Philips Ultrasound, Inc
Philips C9-5EC Transducer.
Medical Devices·5,230 affected·May 28, 2025
High RiskFDA
Encore Medical, Lp
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm Model/Catalog Number: 506-04-130 Software Vers...
Medical Devices·200 affected·May 28, 2025
High RiskFDA
Philips Ultrasound, Inc
Philips eL18-4 Transducer.
Medical Devices·5,230 affected·May 28, 2025
High RiskFDA
Philips Ultrasound, Inc
Philips C5-2 Transducer.
Medical Devices·5,230 affected·May 28, 2025
High RiskFDA
Philips Ultrasound, Inc
Philips L12-3 Transducer.
Medical Devices·5,230 affected·May 28, 2025
High RiskFDA
Philips Ultrasound, Inc
Philips X6-1 Transducer.
Medical Devices·5,230 affected·May 28, 2025
High RiskFDA
Philips Ultrasound, Inc
Philips X8-2t Transducer.
Medical Devices·5,230 affected·May 28, 2025
High RiskFDA
Terumo Cardiovascular Systems Corporation
CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial Kit
Medical Devices·28 affected·May 28, 2025
High RiskFDA
Philips Ultrasound, Inc
Philips V6-2 Transducer.
Medical Devices·5,230 affected·May 28, 2025
High RiskFDA
Philips Ultrasound, Inc
Philips S5-1 Transducer.
Medical Devices·5,230 affected·May 28, 2025
High RiskFDA
Encore Medical, Lp
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm Model/Catalog Number: 506-04-118 Software Vers...
Medical Devices·36 affected·May 28, 2025
High RiskFDA
Philips Ultrasound, Inc
Philips S7-2 Transducer.
Medical Devices·5,230 affected·May 28, 2025
High RiskFDA
Philips Ultrasound, Inc
Philips 3D9-3v Transducer.
Medical Devices·5,230 affected·May 28, 2025
High RiskFDA
Philips Ultrasound, Inc
Philips X7-2t Transducer.
Medical Devices·5,230 affected·May 28, 2025
High RiskFDA
Philips Ultrasound, Inc
Philips X5-1 Transducer.
Medical Devices·5,230 affected·May 28, 2025
High RiskFDA
Philips Ultrasound, Inc
Philips S8-3t Transducer.
Medical Devices·5,230 affected·May 28, 2025
High RiskFDA
Philips Ultrasound, Inc
Philips XL14-3 Transducer.
Medical Devices·5,230 affected·May 28, 2025
High RiskFDA
Philips Ultrasound, Inc
Philips C5-1 Transducer.
Medical Devices·5,230 affected·May 28, 2025
High RiskFDA
Philips Ultrasound, Inc
Philips L12-4 Transducer.
Medical Devices·5,230 affected·May 28, 2025
High RiskFDA
Encore Medical, Lp
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm Model/Catalog Number: 506-04-122 Software Vers...
Medical Devices·200 affected·May 28, 2025
High RiskFDA
Stryker Gmbh
Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.
Medical Devices·0 affected·May 28, 2025
High RiskFDA
Microbiologics Inc
KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC¿ 17960; 0621K, St...
Medical Devices·3 affected·May 27, 2025
High RiskFDA
Corin Medical, Ltd.
Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-5...
Medical Devices·341 affected·May 23, 2025
High RiskFDA
Ge Medical Systems, Llc
SIGNA Architect
Medical Devices·0 affected·May 23, 2025
High RiskFDA
Quantum Surgical Sas
EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a user controlled, stereotactic accessory intended to assist i...
Medical Devices·4 affected·May 23, 2025