FDA Device · 2019
FDA Device recalls in 2019
RecallRadar indexes 2,801 FDA Device recall notices published in 2019. By classification: 369 Class I, 2,343 Class II, 89 Class III.
- Ingenia Elition X, Model Number 781358
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - Ingenia 3.0T CX, Model Number 781271
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - Intera 1.5T Achieva CV Nova, Model Number 781174
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - Intera 1.5T CV, Model Number 781107
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - Ingenia 1.5T CX, Model Number 781261
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - Intera 0.5T Standard, Model Number 781101
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - Multiva 1.5T 16 R5, Model Number 781078
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - icumedical ChemoLock Vial Spike, 20mm, REF CL-80S The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental c…
FDA Device · Class I · 2019-03-06 · Icu Medical - AF 550 x 5ML/H FH DL 30hole SAT C,4"IN, Product code MC0050XLYK2 CP, Arrow AutoFuser Disposable Pain Control Pump
FDA Device · Class II · 2019-03-06 · Arrow International - Intera Achieva 1.5T IT Nova, Model Number 781175
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - Monaco Radiation Treatment Planning (RTP) System
FDA Device · Class II · 2019-03-06 · Elekta - Vanguard Knee System Series-A Standard Patella sizes 34mm Item Number: 184766
FDA Device · Class II · 2019-03-06 · Zimmer Biomet - Ingenia Ambition S, Model Number 781359
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - Prodiva CX, Model Number 781070
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - Achieva 3.0T X, Model Number 781344
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - AF w/AS 550 x 0.5-7 ml,w/Y site,DL CPNB, Product code MVAXL2Y CPNB, Arrow AutoFuser Disposable Pain Control Pump
FDA Device · Class II · 2019-03-06 · Arrow International - Ingenia 3.0T, Model Number 781342
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - Equinoxe Preserve Humeral Stem, 8mm Product Usage: The Equinoxe Preserve Stems are indicated for use in skeletally mature individuals with…
FDA Device · Class II · 2019-03-06 · Exactech - Intera 1.5T Explorer/Nova Dual, Model Number 781108
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - Intera Achieva 1.5T Nova, Model Number 781172
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - Intera 1.5T, Model Number 781195
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - Achieva 3.0T TX, Model Number 781345
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - The WinStation Retinal Imager, also known as Merge Eye Station
FDA Device · Class II · 2019-03-06 · Merge Healthcare - AF 550x8ML/H 2ML 15LO 8.7" DUAL CATHS, 4, Product code MT8015XLYK10 CP, Arrow AutoFuser Disposable Pain Control Pump
FDA Device · Class II · 2019-03-06 · Arrow International - MR-OR 1.5T, Model Number 781437
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - Intera 1.5T Power/Pulsar, Model Number 781105
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - Panorama 1.0T, Model Number 781250
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - Intera 1.0T Omni/Stellar, Model Number 781102
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - Achieva 1.5T, Model Number 781178
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - Achieva 3.0T for PET, Model Number 781477
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - Phoenix AST Indicator, Catalog Number 246004
FDA Device · Class II · 2019-03-06 · Becton Dickinson And - Phoenix AST-s Indicator, Catalog Number 246009
FDA Device · Class II · 2019-03-06 · Becton Dickinson And - Achieva 1.5T, Model Number 781343
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - Multiva 1.5T, Model Number 781076
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - Ingenia 1.5T, Model Number 781396
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - Vitality¿ Spinal Fixation System.Spinal Intervertebral Body, Appliance, Fixation (non-sterile)
FDA Device · Class II · 2019-03-06 · Zimmer Biomet Spine - Prodiva CS, Model Number 781069
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - Intera 3.0T Master/Quasar Dual, Model Number 781150
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - Ingenia 3.0T, Model Number 781377
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - Curity All Purpose Sponges, Non-woven, 4 Ply, 4" x 4" (10.2 cm x 10.2 cm) Product Code: 8044 - Product Usage: Ideal for applying ointments,…
FDA Device · Class II · 2019-03-06 · Cardinal Health 200 - Achieva 1.5T, Model Number 781296
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - AF550x5ML/H 2ML 60LO 6" CATH, 4.5" IN, Product code MT5060XLSK5 CP, Arrow AutoFuser Disposable Pain Control Pump
FDA Device · Class II · 2019-03-06 · Arrow International - Bag size #4 Custom Convenience Kits Usage: Surgical convenience kits labeled as the following: a. Tray Name: PACK BASIC SET UP LH - 2035102…
FDA Device · Class II · 2019-03-06 · American Contract Systems - Vitek 2 reagent cards: a) GN ID, REF 21341, b) GP ID, REF 21342, c) ANC ID, REF 21347, d) AST-GNOR, REF 22000, e) AST-GP67, REF 22226, f) A…
FDA Device · Class II · 2019-03-06 · Organon Teknika - Intera 1.5T Master/Nova, Model Number 781106
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - MR RT, Model Number 781439
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - LIFEPAK 15 Monitor/Defibrillator service kits Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15) is a complete acute cardiac car…
FDA Device · Class I · 2019-03-06 · Physio Control - Alcon or Endure Ophthalmic Microscope Product Usage: Used for low magnification visualization during ophthalmic surgical procedures for cat…
FDA Device · Class II · 2019-03-06 · Alcon Research Laboratories - Multiva 1.5T 16 R5 (ZBO), Model Number 781073
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - Intera 1.5T R11, Model Number 781170
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - Achieva 1.5T Conversion, Model Number 781283
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - Intera 1.5T High Performance, Model Number 781295
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - Intera Achieva 1.5T IT Nova Dual, Model Number 781176
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - LIFEPAK 15 Monitor/Defibrillator Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15) is a complete acute cardiac care response sy…
FDA Device · Class I · 2019-03-06 · Physio Control - Achieva 1.5T High Performance, Model Number 781196
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - Enterprise 1.5T, Model Number 781145
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - Achieva 1.5T Conversion, Model Number 781346
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - 0F 550 x 8ML/HR 2ML 60LO CPNB, Product code MT8060XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
FDA Device · Class II · 2019-03-06 · Arrow International - Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-2, Order Number G35569 The Entuit Secure Gastrointestinal Suture…
FDA Device · Class II · 2019-03-06 · Cook - NZM101 Ingenia 1.5T Linac, Model Number 781483
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - AF w/AS 550 x 1-14ML/HR 5ML-60LO CPNB, Product code MVBX60XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
FDA Device · Class II · 2019-03-06 · Arrow International - MR-OR 3.0T, Model Number 781438
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - AF w/AS 550x 0.5 7 ml/hr, 5ml 30 LO CPNB, Product code MVAX30XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
FDA Device · Class II · 2019-03-06 · Arrow International - Vanguard Knee System Series-A Standard Patella sizes 31mm Item Number: 184764
FDA Device · Class II · 2019-03-06 · Zimmer Biomet - Vitality¿ Spinal Fixation System
FDA Device · Class II · 2019-03-06 · Zimmer Biomet Spine - Phoenix AP AST Indicator Bag, Catalog Number 246006
FDA Device · Class II · 2019-03-06 · Becton Dickinson And - Intera IT, Model Number 781160
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - BRANSIST safire Product Usage: DIGITAL ANGIOGRAPHY SYSTEM This system is intended to be used for radiologic visualization of the heart, blo…
FDA Device · Class II · 2019-03-06 · Shimadzu Medical Systems Usa Com - Ingenia 1.5T, Model Number 781341
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - Draco Enzymatic Deep-Cleaning Pads, Product Number HY0305Z Product Usage: Multi-tiered enzymatic detergent contains lipase, carbohydrase, a…
FDA Device · Class II · 2019-03-06 · Madison Polymeric Engineering - Intera Achieva 1.5T Nova Dual, Model Number 781173
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - Achieva 3.0T, Model Number 781177
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-3, Order Number G35570 The Entuit Secure Gastrointestinal Suture…
FDA Device · Class II · 2019-03-06 · Cook - PLUS 30 PRIORITY PACK Accessory Kit Product Usage: Is recommended for use during vascular procedures in conjunction with interventional and…
FDA Device · Class II · 2019-03-06 · Abbott Vascular - MARLIN 1.5T, Model Number 781474
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - AF 550 x 5ML/H 6" CATH, 4.5" IN, Product code MC0050XLSK5 CP, Arrow AutoFuser Disposable Pain Control Pump
FDA Device · Class II · 2019-03-06 · Arrow International - Ingenia 1.5T S, Model Number 781347
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - AF550x5ML/H 2ML 60LO 6" DUAL CATHS, 4.5", Product MT5060XLYK5 CP, Arrow AutoFuser Disposable Pain Control Pump
FDA Device · Class II · 2019-03-06 · Arrow International - Ingenia 1.5T CX (ZBO), Model Number 781262
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - AF 550 x 5ML/HR 2ML 60LO CPNB, Product code MT5060XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
FDA Device · Class II · 2019-03-06 · Arrow International - AF w/AS 550 x 1-14ML/HR 2ML-30LO CPNB, Product code MVBT30XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
FDA Device · Class II · 2019-03-06 · Arrow International - Panorama 1.0T, Model Number 781350
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - AF 550 x 5ML/HR CPNB, Product code MC0050XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
FDA Device · Class II · 2019-03-06 · Arrow International - Intera 1.0T Power/Pulsar, Model Number 781103
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - Ingenia Elition S, Model Number 781357
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - AF w/AS 550 x 1-14 ml/hr, 5ml30 LOCPNB, Product code MVBX30XLCPNB, Arrow AutoFuser Disposable Pain Control Pump
FDA Device · Class II · 2019-03-06 · Arrow International - Multiva 1.5T 8 R5 (ZBO), Model Number 781072
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - Achieva 7.0T, Model Number 781240
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - Achieva 3.0T X-series, Model Number 781277
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - Vitality¿ Spinal Fixation System
FDA Device · Class II · 2019-03-06 · Zimmer Biomet Spine - Sensis Vibe System, Model Number 11007642, with software version VD10B
FDA Device · Class II · 2019-03-06 · Siemens Medical Solutions Usa - Intera Achieva 1.5T Pulsar, Model Number 781171
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - AF w/AS 550 x 1-14ML/HR CPNB, Product code MVBXL- CPNB, Arrow AutoFuser Disposable Pain Control Pump
FDA Device · Class II · 2019-03-06 · Arrow International - Achieva 3.0T TX for PET, Model Number 781479
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - Hermes NC PTA Balloon Dilatation Catheter The balloon dilatation catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral…
FDA Device · Class II · 2019-03-06 · Brosmed Medical - SmartPath to dStream for 1.5T, Model Number 781260
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - Achieva 3.0T TX-series, Model Number 781278
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - Intera 1.5T Omni/Stellar, Model Number 781104
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - daVinci Harmonic ACE Curved Shears
FDA Device · Class II · 2019-02-27 · Intuitive Surgical - PROVEO 8 Ophthalmic Microscope System optical instrument for improving the visibility of objects through magnification and illumination
FDA Device · Class II · 2019-02-27 · Leica Microsystems
Other years
2026 (2,088) · 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)