Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 71 of 548
FDA Devices Low Jul 10, 2024
VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrat…
Ortho-Clinical Diagnostics, Inc.
FDA Devices Moderate Jul 10, 2024
BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units
CareFusion 303, Inc.
FDA Devices Moderate Jul 10, 2024
Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY
Abbott Medical
FDA Devices Moderate Jul 10, 2024
IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100
Angiodynamics, Inc.
FDA Devices Moderate Jul 10, 2024
Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 35-55mm Model/Catalog Number: MR2102035 Product Description: Cranial Caudal Bl…
SEASPINE ORTHOPEDICS CORPORATION
FDA Devices Moderate Jul 10, 2024
Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22, spacing:2-6-2MM, Length 115 c…
Stryker Sustainability Solutions
FDA Devices Moderate Jul 10, 2024
Non-sterile convenience kits: a. Medline CC Drawer 4 IV Circulation, Pack #ACC010254B, containing a Pure Pouch component DYND04000, O.R. Scissors …
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Jul 10, 2024
Non-sterile convenience kits: Medline Open Heart CDS, Pack #CDS981759C, containing a Pure Pouch with component Reorder #DYNJ04048, Kelly Forceps/S…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Jul 10, 2024
Sterile surgical convenience kits: a. Medline Cath Lab Special Procedure, Pack #00-RDF0360, containing a Pure Pouch with component Medline Reord…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Jul 10, 2024
EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuite 4K- The EasySuite 4K system includes a touch panel user interface for …
Olympus Corporation of the Americas
FDA Devices Critical Jul 10, 2024
Brand Name: MEGADYNE" MEGA 2000" Patient Return Electrode Product Name: MEGADYNE" MEGA 2000" Patient Return Electrode Model/Catalog Number: 0800 S…
Megadyne Medical Products, Inc.
FDA Devices Moderate Jul 10, 2024
Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20, SZ. M; c) 100-22-21, SZ…
Exactech, Inc.
FDA Devices Moderate Jul 3, 2024
EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defibrillator
Medtronic Inc.
FDA Devices Moderate Jul 3, 2024
COBALT DR MRI SureScan, Model Number DDPB3D1, Implantable Cardioverter Defibrillator
Medtronic Inc.
FDA Devices Moderate Jul 3, 2024
COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator
Medtronic Inc.
FDA Devices Moderate Jul 3, 2024
NovaGuide 2 Traditional Ultrasound , REF: NSC-TCDNG2
NovaSignal Corp.
FDA Devices Moderate Jul 3, 2024
Cobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter Defibrillator
Medtronic Inc.
FDA Devices Moderate Jul 3, 2024
COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter Defibrillator
Medtronic Inc.
FDA Devices Moderate Jul 3, 2024
The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following: 1. VasoView Hemopro 2, Model Number: VH-4000. 2. VasoView Hem…
Maquet Cardiovascular, LLC
FDA Devices Moderate Jul 3, 2024
2nd Generation CentriMag Primary Console, REF: 201-90401, 201-90701, 201-90411, 201-90421, 201-30300, L201-90401, L201-90411, L201-90421, part of the…
Thoratec Switzerland GMBH
FDA Devices Moderate Jul 3, 2024
MIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter Defibrillator
Medtronic Inc.
FDA Devices Moderate Jul 3, 2024
CARESCAPE Canvas 1000, Model Numbers: a) 5865770; b) 5865770-01040169; c) 5865770-01054142; d) 5865770-01054696; e) 5865770-01054698; f) 58657…
GE Healthcare Finland Oy
FDA Devices Moderate Jul 3, 2024
CARESCAPE Canvas Smart Display, Model Numbers: a) 5514418, b) 5514418 / MAEP2, c) 5514418-01059642, d) 5514418-01080402, e) 5514418-01081317,…
GE Healthcare Finland Oy
FDA Devices Moderate Jul 3, 2024
AXIOM Vertix MD - The Vertix MD Trauma has been specially designed for examining emergency and accident patients as well as for use in outpatient de…
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Jul 3, 2024
Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint 500e Blood Gas System (China) 114…
Siemens Healthcare Diagnostics Inc
FDA Devices Moderate Jul 3, 2024
The D*Clot¿ HD Rotational Thrombectomy System is a percutaneous catheter-based system available in 6 French. The disposable system consists of an ou…
Mermaid Medical A/S
FDA Devices Moderate Jul 3, 2024
Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System.
Stryker GmbH
FDA Devices Moderate Jul 3, 2024
COBALT DR MRI SureScan, Model Number DDPB3D4, Implantable Cardioverter Defibrillator
Medtronic Inc.
FDA Devices Moderate Jul 3, 2024
CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibrillator
Medtronic Inc.
FDA Devices Moderate Jul 3, 2024
Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.
SIGHT DIAGNOSTICS LTD
FDA Devices Moderate Jul 3, 2024
CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and har…
Integra LifeSciences Corp.
FDA Devices Moderate Jul 3, 2024
CARESCAPE B850 Model Numbers: a) MBC303, Model Numbers: 1) 2078633-001, 2) 2078633-010, 3) 2078633-012, 4) 2078633-017, 5) 2078633-028, 6) …
GE Healthcare Finland Oy
FDA Devices Moderate Jul 3, 2024
MIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter Defibrillator
Medtronic Inc.
FDA Devices Critical Jul 3, 2024
Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life2000 Ventilator System, with Product Codes BT-20-0002, BT-20-0002A and B…
Baxter Healthcare Corporation
FDA Devices Moderate Jul 3, 2024
CARESCAPE B650: Model Numbers: a) MBB313, Model Numbers: 1) 2095801-001, 2) 2095801-001-01018416, 3) 2095801-001-01023150, 4) 2095801-001-010…
GE Healthcare Finland Oy
FDA Devices Critical Jul 3, 2024
SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567…
Philips North America Llc
FDA Devices Moderate Jul 3, 2024
MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP S…
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Jul 3, 2024
NovaGuide 2 Intelligent Ultrasound, REFs: NSC-NVGSYS2 & NSC-NVGSYS2-CA
NovaSignal Corp.
FDA Devices Moderate Jul 3, 2024
COBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter Defibrillator
Medtronic Inc.
FDA Devices Moderate Jul 3, 2024
Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Rev 20, 21, and 23
Draeger Medical Systems, Inc.
FDA Devices Moderate Jul 3, 2024
Titan Scaler Tip - Perio Model/Catalog Number: 261669 The scaler tip is used with an air drive scaler for subgingival scaling and fine access. …
Dental EZ Group Star Dental Division
FDA Devices Moderate Jul 3, 2024
CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11
Centers For Disease Control and Prevention
FDA Devices Moderate Jul 3, 2024
PRIMO MRI DR SureScan, Model Number DDMD3D1, Implantable Cardioverter Defibrillator
Medtronic Inc.
FDA Devices Moderate Jul 3, 2024
Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP -PG5F45R -PG5F45S -PG5F45S018 -PG5F90MP -PG5F90S -PG5F90S018 -PG6F45HS -PG6…
Merit Medical Systems, Inc.
FDA Devices Moderate Jul 3, 2024
MIRRO MRI VR SureScan, Model Number DVME3D1, Implantable Cardioverter Defibrillator
Medtronic Inc.
FDA Devices Moderate Jul 3, 2024
Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101
ASPEN SURGICAL
FDA Devices Moderate Jul 3, 2024
COBALT XT HF CRT-D MRI SureScan, Model Number: DTPA2D1, Implantable Cardioverter Defibrillator
Medtronic Inc.
FDA Devices Critical Jul 3, 2024
SENSE XL TORSO COIL 3.0T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 4535673…
Philips North America Llc
FDA Devices Moderate Jul 3, 2024
EVERA S VR, Model Number DVBC3D1, Implantable Cardioverter Defibrillator
Medtronic Inc.
FDA Devices Moderate Jul 3, 2024
AXIOM MULTIX MP - Inended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic d…
Siemens Medical Solutions USA, Inc