FDA Device · 2015
FDA Device recalls in 2015
RecallRadar indexes 2,495 FDA Device recall notices published in 2015. By classification: 77 Class I, 2,300 Class II, 118 Class III.
- Neuro Combo Set Case The cases hold surgical instrumentation in place during handling and storage
FDA Device · Class II · 2015-10-28 · Biomet Microfixation - Perifix Continous Epidural Anesthesia Pain Control Trays
FDA Device · Class II · 2015-10-28 · B Braun Medical - TELETOM EQUIPMENT MANAGEMENT SYSTEM 4 and 6 series TELETOM is designed for use in operating rooms, medical treatment rooms, intensive care…
FDA Device · Class II · 2015-10-28 · Berchtold - ConFormis iTotal CR Knee Replacement System- ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - LEFT ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED -…
FDA Device · Class II · 2015-10-28 · Conformis - Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 6.5 mm, Sterile Part Number: 7209236 Intended Use: For arthroscopic (knee and…
FDA Device · Class II · 2015-10-28 · Smith And Nephew Endoscopy Div - ConForMIS iDuo Bicompartmental Knee Replacement System iDUO G2, Left Lateral Catalog Number: M57230600230
FDA Device · Class II · 2015-10-28 · Conformis - OneTray Sealed Sterilization Containers Product Usage: A rigid sterilization container used to steam sterilize medical devices
FDA Device · Class II · 2015-10-28 · Innovative Sterlization Technologies - 5.0mm Unit Rod 270mm, 5.0mm Unit Rod 290mm, 5.0mm Unit Rod 310mm, 5.0mm Unit Rod 330mm, 5.0mm Unit Rod 350mm, 5.0mm Unit Rod 370mm, 5.0mm U…
FDA Device · Class II · 2015-10-28 · Synthes Usa Products - ConFormis iTotal CR Knee Replacement System- iTOTAL CR, Right Knee Catalog Number: M57250600020 (US) M5725INT0600020 (OUS)
FDA Device · Class II · 2015-10-28 · Conformis - XiO Radiation Treatment Planning System
FDA Device · Class II · 2015-10-28 · Elekta - ConForMIS iTotal CR (Cruciate Retaining) Knee Replacement System-iTOTAL CR, Left Knee Catalog Number: M57250600010 (US) M5725INT0600010 (OU…
FDA Device · Class II · 2015-10-28 · Conformis - Natus neoBLUE 3 Phototherapy system or Neonatal Phototherapy, Catalogue Part Number: 010066
FDA Device · Class II · 2015-10-28 · Natus Medical - ConForMIS iUni Unicondylar Knee Replacement System: iUNI G2, Left Lateral Catalog Number: M57220600230 (US) M5722INT0600230 (OUS)
FDA Device · Class II · 2015-10-28 · Conformis - ConFormis iTotal Posterior Stabilized Knee Replacement System- ITOTAL PS-IPOLY- IMPLANT KIT-LEFT and ITOTAL PS-IPOLY-IMPLANT KIT-RIGHT Cata…
FDA Device · Class II · 2015-10-28 · Conformis - Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 4.5 mm, Sterile Part Number: 7209235 Intended Use: For arthroscopic (knee and…
FDA Device · Class II · 2015-10-28 · Smith And Nephew Endoscopy Div - ConForMIS iUNI Unicondylar Knee Replacement System iUNI G2, Right Lateral Catalog Number: M57220600240 (US) M5722INT0600240 (OUS)
FDA Device · Class II · 2015-10-28 · Conformis - AltiVate Humeral Socket Shell Trial, Part Number 804-06-052 The glenoid baseplate is intended for cementless application with addition of s…
FDA Device · Class II · 2015-10-28 · Encore Medical - ConForMIS iDuo Knee Bicompartmental Knee Replacement System , iDUO G2, Right Medial Catalog Number: M57230600220 (US) M5723INT0600220 (OUS)
FDA Device · Class II · 2015-10-28 · Conformis - ConFormis iDUO G2, Right Lateral Catalog Number: M5723INT0600240 (US) M5723INT0600240 (OUS)
FDA Device · Class II · 2015-10-28 · Conformis - Ambitex NMD400 Nitrile Exam Gloves size medium
FDA Device · Class II · 2015-10-28 · Cardinal Health - PORT-A-CATH Plastic Hub Needles, 0.9mm (20G) x 19mm (3/4 in.) 90-degree
FDA Device · Class II · 2015-10-28 · Smiths Medical Asd - ConForMIS iUni Unicondylar Knee Replacement System- iUNI G2, Right Medial Catalog Number:M57220600220 (US) M5722INT0600220 (OUS)
FDA Device · Class II · 2015-10-28 · Conformis - ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLACEMENT
FDA Device · Class II · 2015-10-28 · Baxter Healthcare - Toshiba Aquilion CT System TSX-301B
FDA Device · Class II · 2015-10-21 · Toshiba American Medical Systems - Toshiba Aquilion CT System TSX-301A
FDA Device · Class II · 2015-10-21 · Toshiba American Medical Systems - Toshiba Aquilion CT System TSX-303A
FDA Device · Class II · 2015-10-21 · Toshiba American Medical Systems - Synthes Screw Inserter
FDA Device · Class II · 2015-10-21 · Synthes Usa Products - Alere Cholestech LDX Multianalyte Controls, PN 88769 and 88773
FDA Device · Class III · 2015-10-21 · Alere San Diego - Toshiba Aquilion CT System TSX-101A
FDA Device · Class II · 2015-10-21 · Toshiba American Medical Systems - Toshiba Aquilion CT System TSX-301C
FDA Device · Class II · 2015-10-21 · Toshiba American Medical Systems - MRIdian¿ ViewRay¿ Radiation Therapy System, ViewRay¿ Is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tum…
FDA Device · Class II · 2015-10-21 · Viewray - Synthes 2.7MM/3.5MM VA-LCP Medial Distal Humerus Plates 10H/RT/186mm- Sterile and Synthes 2.7MM/3.5MM VA-LCP Extended Medial Distal Humerus…
FDA Device · Class II · 2015-10-21 · Synthes Usa Products - NicoletOne Software v5.94, Catalog/Part Number: 482-649600
FDA Device · Class II · 2015-10-21 · Natus Neurology - Zimmer Natural Nail CM Long
FDA Device · Class II · 2015-10-21 · Zimmer - Monode, Shortwave Accessory Model #: 02200002 Used in conjunction with the Intelect Shortwave Diathermy 100 and Intelect Shortwave Diatherm…
FDA Device · Class II · 2015-10-21 · Djo - Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF 90960
FDA Device · Class II · 2015-10-21 · Concentric Medical - Toshiba Aquilion CT System TSX-302A
FDA Device · Class II · 2015-10-21 · Toshiba American Medical Systems - 4FR Single Lumen Pressure Injectable PICC
FDA Device · Class II · 2015-10-21 · Arrow International - Inserter for Titanium Elastic Nails (TEN), orthopedic device
FDA Device · Class II · 2015-10-21 · Synthes Usa Products - -Pipeline Embolization Device -Pipeline Flex Embolization Device The Pipeline and Pipeline Flex Embolization Devices consist of a permanent…
FDA Device · Class II · 2015-10-21 · Micro Therapeutics - The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartu…
FDA Device · Class II · 2015-10-21 · Clinical Innovations - Universal Compact Head Ring Adapter Plate (UCHRAP), a component of the Universal Compact Head Ring Adapter, UCHRA. The UCHRA is a component…
FDA Device · Class II · 2015-10-14 · Integra Lifesciences - regard Item Number: 800411001, Sterile, NU0480A - Neuro Pk - surgical kit containing cover light handle soft, RX. The responsible firm on t…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800410001, Sterile, CV0479A - Open Heart Pk - surgical kit containing cover light handle soft, RX. The responsible firm…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800419, Sterile, GY0488 - D&C Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the lab…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800559, Sterile, ET0648 - Head & Neck - surgical kit containing cover light handle soft, RX. The responsible firm on th…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800526, Sterile, ET0610 - Head and Neck - surgical kit containing cover light handle soft, RX. The responsible firm on…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800567, Sterile, GY0656 - Robotic Hysterectomy - surgical kit containing cover light handle soft, RX. The responsible f…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 880323, Sterile, LD0754 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800568, Sterile, OR0658 - Titanium Rib - surgical kit containing cover light handle soft, RX. The responsible firm on t…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - Access Free T3 Reagent Kit, P/N A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitati…
FDA Device · Class II · 2015-10-14 · Beckman Coulter - MICroSTREP plus 2 Panel, Part No. B1027-202 Product Usage: MicroScan MICroSTREP plus panels are designed for use in determining quantitativ…
FDA Device · Class II · 2015-10-14 · Beckman Coulter - regard Item Number: 800411002, Sterile, NU0480B - Neuro Pk - surgical kit containing cover light handle soft, RX. The responsible firm on t…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - Medtronic Medical Device Identification Card for SureScan pacemaker patients
FDA Device · Class II · 2015-10-14 · Medtronic Cardiac Rhythm Disease Management - SOMATOM Force
FDA Device · Class II · 2015-10-14 · Siemens Medical Solutions Usa - regard Item Number: 800528001, Sterile, GS0612A - Lap Chole Pk - surgical kit containing cover light handle soft, RX. The responsible firm…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - SOMATOM Definition AS, intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from ei…
FDA Device · Class II · 2015-10-14 · Siemens Medical Solutions Usa - regard Item Number: 800407, Sterile, OR0476 - Ortho Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the l…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800555, Sterile, HT0644 - Pediatric Card Cath - surgical kit containing cover light handle soft, RX. The responsible fi…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 880327, Sterile, CV0758 - Open Heart A&B - surgical kit containing cover light handle soft, RX. The responsible firm on…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800560001, Sterile, GS0649A - Lap Chole - surgical kit containing cover light handle soft, RX. The responsible firm on…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800413, Sterile, CV0482 - Vascular Pk - surgical kit containing cover light handle soft, RX. The responsible firm on th…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800401, Sterile, GS0470 - Lap Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the lab…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number 800567001, Sterile, GY0656A - Robotic Hysterectomy - surgical kit containing cover light handle soft, RX. The responsibl…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - MICroSTREP plus 1 Panel, Part No. B1027-201 Product Usage: MicroScan MICroSTREP plus panels are designed for use in determining quantitativ…
FDA Device · Class II · 2015-10-14 · Beckman Coulter - MAJ-1606 Instrument Channel Adaptor
FDA Device · Class II · 2015-10-14 · Olympus - regard Item Number: 800533, Sterile, GS0606 - Abdominal Pk - surgical kit containing cover light handle soft, RX. The responsible firm on t…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 880327002, sterile, CV0758B - Open Heart A&B - surgical kit containing cover light handle soft, RX. The responsible fir…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800599, Sterile, GS0694 - Robotic Lap - surgical kit containing cover light handle soft, RX. The responsible firm on th…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from…
FDA Device · Class II · 2015-10-14 · Ge Healthcare - regard Item Number: 800623, Sterile, NU0787 - Neuro - surgical kit containing light handle soft, RX. The responsible firm on the label is R…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - Celesteion PCA-9000A/2 PET/CT System
FDA Device · Class II · 2015-10-14 · Toshiba American Medical Systems - regard Item Number: 800550, Sterile, OR0639 - Hip Shoulder - surgical kit containing cover light handle soft, RX. The responsible firm on t…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800091, Sterile, LD0692 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800036002, Sterile, LD0274B - C Section Pack - surgical kit containing cover light handle soft, RX. The responsible fir…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800554002, Sterile, GS0643B - Pediatric Basic - surgical kit containing cover light handle soft, RX. The responsible fi…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800560, Sterile, GS0649 - Lap Chole - surgical kit containing cover light handle soft, RX. The responsible firm on the…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800408001, Sterile, LD0477A - C-Section Pk - surgical kit containing cover light handle soft, RX. The responsible firm…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800514, Sterile, LD0592 - C Section Pack - surgical kit containing cover light handle soft, RX. The responsible firm on…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800566, Sterile, NU0655 - VP Shunt - surgical kit containing cover light handle soft, RX. The responsible firm on the l…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 880330, Sterile, OR0761 - Total Hip - surgical kit containing cover light handle soft, RX. The responsible firm on the…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800548, Sterile, OR0637 - Extremity - surgical kit containing cover light handle soft, RX. The responsible firm on the…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800554, Sterile, GS0643 - Pediatric Basic - surgical kit containing cover light handle soft, RX. The responsible firm o…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 880326, Sterile, GS0757 - Major Basin - surgical kit containing cover light handle soft, RX. The responsible firm on th…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800524001, Sterile, LD0608A - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800553, Sterile, OR0642 - Total Knee - surgical kit containing cover light handle soft, RX. The responsible firm on the…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800569, Sterile, CV0659 - Open Heart A & B - surgical kit containing cover light handle soft, RX. The responsible firm…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800525, Sterile, OR0609 - Extremity Pack - surgical kit containing cover light handle soft, RX. The responsible firm on…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800558, Sterile, OR0647 - Extremity - surgical kit containing cover light handle soft, RX. The responsible firm on the…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - Specialist 2 Intramedullary (SP2 IM) Rod 400mm Instrument (PN 96-6120) The SP2 IM Rod 400mm Instrument (PN 96-6120) is used in both primary…
FDA Device · Class II · 2015-10-14 · Depuy Orthopaedics - regard Item Number: 800528, Sterile, GS0612 - Lap Chole Pk - surgical kit containing cover light handle soft, RX. The responsible firm on t…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800527, Sterile, OR0611 - Hip Shoulder Pk - surgical kit containing cover light handle soft, RX. The responsible firm o…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800416, Sterile, GY0485 - Robotic Hysterectomy Pkg - surgical kit containing cover light handle soft, RX. The responsib…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800615, Sterile, CV0741 - Peripheral Vascular - surgical kit containing cover light handle soft, RX. The responsible fi…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - Disposable Paper Filter for Sterilization Containers Paper, Medical Accessory, 100 DISP, Paper F, Steri.Cases, New Shape, Manufactured and…
FDA Device · Class II · 2015-10-14 · Stryker Craniomaxillofacial Division - Monaco Radiation Treatment Planning System
FDA Device · Class II · 2015-10-14 · Elekta - regard Item Number: 800551, Sterile, GS0640 - Lap Chole - surgical kit containing cover light handle soft, RX. The responsible firm on the…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800410, Sterile, CV0479 - Open Heart Pk - surgical kit containing cover light handle soft, RX. The responsible firm on…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800524, Sterile, LD0608 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number 800568001, Sterile, OR0658A - Titanium Rib - surgical kit containing cover light handle soft, RX. The responsible firm o…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation
Other years
2026 (2,024) · 2025 (2,908) · 2024 (3,393) · 2023 (2,477) · 2022 (2,191) · 2021 (2,303) · 2020 (3,055) · 2019 (2,801) · 2018 (3,757) · 2017 (2,615) · 2016 (3,246) · 2015 (2,495) · 2014 (3,059) · 2013 (2,249) · 2012 (1,310)