Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 184 of 548
FDA Devices Critical Apr 14, 2021
Medtronic HVAD Battery, Product Number: 1650, 1650CA-CLIN, 1650DE
Heartware, Inc.
FDA Devices Moderate Apr 14, 2021
Amicus Exchange Kit - Product Usage: intended for use in the collection of blood components and mononuclear cells.
Fenwal Inc
FDA Devices Moderate Apr 14, 2021
Premium At Home Pro Series Insemination Kit (SKU 644042787927)
Tenderneeds Fertility LLC
FDA Devices Moderate Apr 14, 2021
Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy, Product Code: 9464-VC-006 (US) Product Code: 9464-EU-001 (sold…
Arrow International Inc
FDA Devices Moderate Apr 14, 2021
Enteral Infusion Pump
Cardinal Health 200, LLC
FDA Devices Critical Apr 14, 2021
Medtronic HVAD Monitor Data Cable, Product Number: 1575
Heartware, Inc.
FDA Devices Moderate Apr 14, 2021
At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894, 636391205900, 636391205924, 636391205863, 636391205931, 63639120584…
Tenderneeds Fertility LLC
FDA Devices Moderate Apr 14, 2021
Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick Connect), an articulating arm with links, a…
Terumo Cardiovascular Systems Corporation
FDA Devices Moderate Apr 14, 2021
Professional Clinical Artificial Intrauterine Insemination Kit (SKU 636391205962, 636391206013)
Tenderneeds Fertility LLC
FDA Devices Moderate Apr 14, 2021
EXTREME H2O 59% (hioxifilcon A) spherical soft contact lens for daily wear - Product Usage: indicated for the correction of visual acuity in aphakic …
Clerio Vision
FDA Devices Moderate Apr 14, 2021
NUVASIVE PRECICE UNYTE System (Humerus and Tibia): PRECICE Trauma Nail System/PRECICE Unyte-Humerus Orthopedic trauma intramedullary rod, humerus…
Nuvasive Specialized Orthopedics Inc
FDA Devices Moderate Apr 14, 2021
BD BBL Martin-Lewis Agar, 100 Ea - Product Usage: used for the isolation of pathogenic Neisseria from specimens containing mixed flora of bacteria a…
Becton Dickinson & Co.
FDA Devices Moderate Apr 14, 2021
Trial Cutting Guide for Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System, prosthesis, knee, patellofemorotibial, semi-cons…
Howmedica Osteonics Corp.
FDA Devices Critical Apr 14, 2021
Power Supply: 1. Medtronic HVAD Controller AC Adapter, Product Numbers: 1425AU, 1425CA, 1425DE, 1425GB, 1425IL, 1425IT, 1425US, 1430AR, 1430AU, 143…
Heartware, Inc.
FDA Devices Moderate Apr 14, 2021
BD BBL Martin-Lewis Agar 20 Ea - Product Usage: use for the isolation of pathogenic Neisseria from specimens containing mixed flora of bacteria and f…
Becton Dickinson & Co.
FDA Devices Critical Apr 14, 2021
Medtronic HVAD Alarm Adapter, Product Number: 1450
Heartware, Inc.
FDA Devices Moderate Apr 14, 2021
Amicus MNC Apheresis Kit - Double Needle - Product Usage: intended for use in the collection of blood components and mononuclear cells.
Fenwal Inc
FDA Devices Moderate Apr 14, 2021
At Home Artificial Intrauterine Insemination Flex Set (SKU 636391205870)
Tenderneeds Fertility LLC
FDA Devices Critical Apr 14, 2021
Medtronic HVAD Packaged Monitor, Model Numbers: 1500, 1500AU, 1500DE, 1510US, 1511AR, 1511AU, 1511BR, 1511CA, 1511CH, 1511DE, 1511GB, 1511IL, 1511IN…
Heartware, Inc.
FDA Devices Critical Apr 14, 2021
Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410
Tenacore LLC
FDA Devices Moderate Apr 14, 2021
NUVASIVE FREEDOM: End Cap for PRECICE Intramedullary Limb Lengthening System Implant; Packaged End Cap 8.5/10.7mm,¿ +0mm; Packaged End Cap 8.5/1…
Nuvasive Specialized Orthopedics Inc
FDA Devices Moderate Apr 14, 2021
Ysio X.pree, Model Number: 11107464 - Product Usage: A Digital X-Ray System generate Xray images from the whole body including the skull, chest, abd…
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Apr 14, 2021
MicroScan WalkAway-96 plus Reconditioned Instrument
Beckman Coulter Inc.
FDA Devices Moderate Apr 14, 2021
MicroScan WalkAway-96 plus Instrument
Beckman Coulter Inc.
CPSC Moderate Apr 12, 2021
Black Diamond Recalls PIEPS DSP Avalanche Transceivers Due to Risk of Loss of Emergency Communications; One Death Reported
Pieps GMBH, of Austria
CPSC Moderate Apr 8, 2021
Verizon Recalls 2.5 Million Ellipsis Jetpack Mobile Hotspots Imported by Franklin Wireless Due to Fire and Burn Hazards
Cellco Partnership, d/b/a Verizon Wireless, of Basking Ridge, New Jersey
FDA Devices Moderate Apr 7, 2021
PRECICE PLATE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone t…
Nuvasive Specialized Orthopedics Inc
FDA Devices Moderate Apr 7, 2021
EPIX Therapeutics DiamondTemp Bidrectional Large Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDTB400L, Steri…
EPIX THERAPEUTICS, INC
FDA Devices Critical Apr 7, 2021
Implantable cardioverter defibrillators (ICD) with cardiac resynchronization therapy (CRT-D): 1) Viva family: Viva XT CRT-D, Viva XT Quad CRT-D, Viv…
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
FDA Devices Moderate Apr 7, 2021
ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar components designed to replace the natura…
DePuy Orthopaedics, Inc.
FDA Devices Moderate Apr 7, 2021
EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Small Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:DT100S,Steri…
EPIX THERAPEUTICS, INC
FDA Devices Moderate Apr 7, 2021
Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmonic ACE +7, Shears with Advanced Hemostasis 5mm Diameter x 36cm - Product…
Stryker Sustainability Solutions
FDA Devices Critical Apr 7, 2021
BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit with Pump Module Keypad, Parts: 49000239;…
CareFusion 303, Inc.
FDA Devices Moderate Apr 7, 2021
PRECICE STRYDE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone …
Nuvasive Specialized Orthopedics Inc
FDA Devices Moderate Apr 7, 2021
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnost…
Siemens Medical Solutions USA, Inc.
FDA Devices Moderate Apr 7, 2021
The ATTUNE¿ Rotating Platform (RP) Total Knee System - Product Usage: consists of multiple components intended to replace the femoral, tibial, and pa…
DePuy Orthopaedics, Inc.
FDA Devices Moderate Apr 7, 2021
EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Large Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:DT200L, Steri…
EPIX THERAPEUTICS, INC
FDA Devices Moderate Apr 7, 2021
The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Product Usage: consists of three components intended to replace the femoral, t…
DePuy Orthopaedics, Inc.
FDA Devices Critical Apr 7, 2021
ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: …
Smisson-Cartledge Biomedical, LLC
FDA Devices Critical Apr 7, 2021
ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: …
Smisson-Cartledge Biomedical, LLC
FDA Devices Moderate Apr 7, 2021
CF Delivery Dev Caps Bravo x5, FGS-0635/FGS 0636 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring of gastric r…
Covidien Llc
FDA Devices Moderate Apr 7, 2021
EPIX Therapeutics DiamondTemp Bidrectional Small Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDTB300S, Steri…
EPIX THERAPEUTICS, INC
FDA Devices Critical Apr 7, 2021
Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1, R560BCS1. Used in cardiopulmonary by…
Medtronic Perfusion Systems
FDA Devices Moderate Apr 7, 2021
EPIX Therapeutics DiamondTemp Unidirectional Small Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF CEDT100S, Ster…
EPIX THERAPEUTICS, INC
FDA Devices Moderate Apr 7, 2021
BRAVO PH CAPS DELIVERY DEV5-PK, FGS-0312/FGS-0313 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring of gastric …
Covidien Llc
FDA Devices Moderate Apr 7, 2021
Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures.
Arthrex, Inc.
FDA Devices Moderate Apr 7, 2021
Alcon Custom Ophthalmic Surgical Procedure Packs
Alcon Research, LLC
FDA Devices Moderate Apr 7, 2021
Vertical Drain Tube Attachment Device (VTAD) (Gastrointestinal tube and accessories) - Product Usage: designed to stabilize and secure a variety of c…
Hollister Incorporated
FDA Devices Moderate Apr 7, 2021
Precice Bone Transport - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, …
Nuvasive Specialized Orthopedics Inc
FDA Devices Moderate Apr 7, 2021
Philips SureSigns VM4, VM6 and VM8 - Product Usage: patient monitors-for monitoring, recording and alarming of multiple physiological parameters of a…
Philips North America, LLC