Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 190 of 548
FDA Devices Moderate Feb 3, 2021
Philips Respironics V60 Ventilator Part Number 1053613 - Product Usage: intended to be used only with various combinations of Respironics-recommended…
Respironics California, LLC
FDA Devices Moderate Feb 3, 2021
ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system
PHILIPS HOME HEALTHCARE SOLUTION
FDA Devices Moderate Feb 3, 2021
Philips Respironics V60 Ventilator Part Number 1053614 - Product Usage: intended to be used only with various combinations of Respironics-recommended…
Respironics California, LLC
FDA Devices Moderate Feb 3, 2021
Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with SureScan technology and Bluetooth w…
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
FDA Devices Moderate Feb 3, 2021
EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
Boston Scientific Corporation
FDA Devices Moderate Feb 3, 2021
Philips Respironics V60 Ventilator Part Number 1053615 - Product Usage: intended to be used only with various combinations of Respironics-recommended…
Respironics California, LLC
FDA Devices Moderate Feb 3, 2021
Philips Respironics V60 Ventilator Part Number 1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended…
Respironics California, LLC
FDA Devices Moderate Feb 3, 2021
Philips Respironics V60 Ventilator Part Number 1076716 - Product Usage: intended to be used only with various combinations of Respironics-recommended…
Respironics California, LLC
FDA Devices Moderate Feb 3, 2021
Philips Respironics V60 Ventilator Part Number 1053618 - Product Usage: intended to be used only with various combinations of Respironics-recommended…
Respironics California, LLC
FDA Devices Moderate Feb 3, 2021
therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRA…
Qiagen Sciences LLC
FDA Devices Moderate Feb 3, 2021
DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis Guidance System (NGS)
Neocis, Inc.
FDA Devices Moderate Feb 3, 2021
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
Boston Scientific Corporation
FDA Devices Moderate Feb 3, 2021
Philips Respironics V60 Ventilator Part Number 1137292 - Product Usage: intended to be used only with various combinations of Respironics-recommended…
Respironics California, LLC
FDA Devices Moderate Feb 3, 2021
Philips Respironics V60 Ventilator Part Number 1076717 - Product Usage: intended to be used only with various combinations of Respironics-recommended…
Respironics California, LLC
FDA Devices Moderate Feb 3, 2021
Philips Respironics V60 Ventilator Part Number R1053618 - Product Usage: intended to be used only with various combinations of Respironics-recommende…
Respironics California, LLC
FDA Devices Moderate Feb 3, 2021
Philips Respironics V60 Plus Ventilator Part Number 1137276 - Product Usage: intended to be used only with various combinations of Respironics-recomm…
Respironics California, LLC
FDA Devices Moderate Feb 3, 2021
Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System
K2M, Inc
FDA Devices Moderate Feb 3, 2021
Philips Respironics V60 Ventilator Part Number DU1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommend…
Respironics California, LLC
FDA Devices Moderate Feb 3, 2021
B. Braun Introcan IV Safety Catheters, sterile - Product Usage: It is a single-use device to generate intravascular and tissue access to sample blood…
Braxton Medical Corporation
FDA Devices Moderate Feb 3, 2021
Philips Respironics V680 Ventilator Part Number 850011 - Product Usage: intended to be used only with various combinations of Respironics-recommended…
Respironics California, LLC
FDA Devices Moderate Feb 3, 2021
SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement proced…
OMNIlife science Inc.
FDA Devices Moderate Feb 3, 2021
Philips Respironics V60 Ventilator Part Number 1053613 - Product Usage: intended to be used only with various combinations of Respironics-recommended…
Respironics California, LLC
FDA Devices Moderate Feb 3, 2021
Medtronic Cobalt HF CRT-D MRI SureScan DTPB2D1, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureSca…
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
FDA Devices Moderate Feb 3, 2021
SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement proce…
OMNIlife science Inc.
FDA Devices Moderate Feb 3, 2021
Philips Respironics V60 Ventilator Part Number R1053618 - Product Usage: intended to be used only with various combinations of Respironics-recommende…
Respironics California, LLC
FDA Devices Moderate Feb 3, 2021
PSG-1100 Sleep Diagnostic System. Sample product label: JB-110A SERIAL No. 01454 RoHS Compliant; PSG-100 Head Box; UDI (01) 04931921108383; Made i…
Nihon Kohden America Inc
FDA Devices Moderate Feb 3, 2021
BD Regional Block Needles 22G x 1.50in (50 units/cs.). Indicated for administration of medications to affect anesthesia or analgesia to a specific an…
Becton Dickinson & Company
FDA Devices Moderate Feb 3, 2021
Philips Respironics V60 Plus Ventilator Part Number 1138747 - Product Usage: intended to be used only with various combinations of Respironics-recomm…
Respironics California, LLC
FDA Devices Moderate Feb 3, 2021
Philips Respironics V60 Ventilator Part Number 1137292 - Product Usage: intended to be used only with various combinations of Respironics-recommended…
Respironics California, LLC
FDA Devices Moderate Feb 3, 2021
Philips Respironics V680 Ventilator Part Number 850011 - Product Usage: intended to be used only with various combinations of Respironics-recommended…
Respironics California, LLC
FDA Devices Moderate Feb 3, 2021
TRx4841A 1.4 GHz IntelliVue Tele TRX, Model Number 862439; Includes System Codes 453564007261, 453564007271, 453564007281, 989803196951
Philips North America, LLC
FDA Devices Moderate Feb 3, 2021
Philips Respironics V60 Ventilator Part Number R1076709 - Product Usage: intended to be used only with various combinations of Respironics-recommende…
Respironics California, LLC
FDA Devices Moderate Feb 3, 2021
Philips Respironics V60 Ventilator Part Number 1076709 - Product Usage: intended to be used only with various combinations of Respironics-recommended…
Respironics California, LLC
FDA Devices Critical Jan 27, 2021
EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD)
Boston Scientific Corporation
FDA Devices Moderate Jan 27, 2021
Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sodium, potassium, ionized calcium, glucose, pH, pCO2, pO2 and hematocri…
Abbott Point Of Care Inc.
FDA Devices Moderate Jan 27, 2021
Laerdal Compact Suction Unit (LCSU 4), Catalog Numbers 880051, 880061, 881151, 880052, 880062, 881152 - Product Usage: It is intended for intermitt…
Laerdal Medical (Suzhou) Co., Ltd.
FDA Devices Moderate Jan 27, 2021
REF 27219-2 X1, Medtronic, Delta Valve, Neonatal, Performance Level 2.0, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies a…
Medtronic Neurosurgery
FDA Devices Critical Jan 27, 2021
Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7KIT The Penumbra JET 7 Reperfusion Catheter with Xtra Flex…
Penumbra Inc.
FDA Devices Moderate Jan 27, 2021
A.L.P.S. Clavicle Plating System, Plate, Fixation, Bone, Item Number 233500004 - Product Usage: indicated for fixation of fractures, osteotomies and …
Biomet, Inc.
FDA Devices Critical Jan 27, 2021
Penumbra JET 7 Reperfusion Catheter REF 5MAXJET7 The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a componen…
Penumbra Inc.
FDA Devices Moderate Jan 27, 2021
REF 27219-5 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.5, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies a…
Medtronic Neurosurgery
FDA Devices Moderate Jan 27, 2021
OsteoVation, Inject Bone Filler Kits, 5cc (part number 390-2005, manufacturing lot number 1129957) - Product Usage: The product provides a bone void …
Skeletal Kinetics, Llc
FDA Devices Moderate Jan 27, 2021
uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001
Roche Molecular Systems, Inc.
FDA Devices Moderate Jan 27, 2021
Equinoxe Humeral Stem, Primary, Press Fit, 11mm
Exactech, Inc.
FDA Devices Moderate Jan 27, 2021
Neurosign 100, Product Number 9883-01. Intraoperative Nerve Monitor - Product Usage: indicated for use in stimulating and monitoring cranial motor ne…
The Magstim Company Limited
FDA Drug Low Jan 20, 2021
Succinylcholine Chloride PF Inj. 200 mg/10 mL, 10 mL single use syringes, Rx only, US Compounding, 1270 Don's Lane, Conway, AR 72032
US Compounding Inc
FDA Devices Moderate Jan 20, 2021
Naturalyte Liquid Acid concentrate bottles, Product Code 08-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…
Fresenius Medical Care Holdings, Inc.
FDA Devices Moderate Jan 20, 2021
SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus
Siemens Medical Solutions USA, Inc
FDA Devices Critical Jan 20, 2021
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF H749LVSUS230, GTIN 08714729960904
Boston Scientific Corporation
FDA Devices Moderate Jan 20, 2021
Naturalyte Liquid Acid concentrate bottles, Product Code 08-2351-8 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…
Fresenius Medical Care Holdings, Inc.