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.
- LEEP Precision Integrated System 120V, Model LP-10-120 Product Usage: The LEEP PRECISION INTEGRATED SYSTEM l 20V combines three components…
FDA Device · Class II · 2019-06-26 · Coopersurgical - EGIA45 CT AR MD THK REL, EGIA45CTAMT
FDA Device · Class II · 2019-06-26 · Covidien - Endotrac EPF/EGR Hook/Triangle Blade Kit, Catalogue Number 3056-1
FDA Device · Class II · 2019-06-26 · Stryker - Prestige II, Prestige SI, Prestige VH Prestige system is a new multi-purpose conventional and digital R/F remote controlled system
FDA Device · Class II · 2019-06-19 · Ge Healthcare - GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10, Model Numbers: a) 2052831-00x b) 2050578-0xx c) 2090228…
FDA Device · Class II · 2019-06-19 · Ge Healthcare - IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.4" (100 cm), Rx Only, Sterile EO The IntraClude intra-aortic o…
FDA Device · Class I · 2019-06-19 · Edwards Lifesciences - Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86682003 Product Usage: The Getinge 86 Series Medical Washer-Disinfector is des…
FDA Device · Class II · 2019-06-19 · Maquet Cardiovascular Us Sales - Precision 500D The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and flu…
FDA Device · Class II · 2019-06-19 · Ge Healthcare - Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Electronic Gas Blender, Catalog #: 801188, UDI 00886799000588
FDA Device · Class II · 2019-06-19 · Terumo Cardiovascular Systems - CardioCommand, Inc
FDA Device · Class III · 2019-06-19 · Cardiocommand - Philips IntelliBridge System configured with a regional setting which uses a comma for a decimal separator: 866417 IntelliBridge System C.0…
FDA Device · Class III · 2019-06-19 · Philips North America - Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86662003 Product Usage: Usage: The Getinge 86 Series Medical Washer-Disinfector…
FDA Device · Class II · 2019-06-19 · Maquet Cardiovascular Us Sales - Prestilix 1600X Prestilix system is a fully integrated remote controlled digital radiology system
FDA Device · Class II · 2019-06-19 · Ge Healthcare - xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitative detection and identification of multiple viral, bacterial an…
FDA Device · Class II · 2019-06-19 · Luminex Molecular Diagnostics - Philips Patient Information Center iX configured with a regional setting which uses a comma for a decimal separator: 866389 Patient Informa…
FDA Device · Class III · 2019-06-19 · Philips North America - Proteus XR/a The Proteus XR/a radiographic system offers the flexibility to choose a configuration based upon your specific requirements
FDA Device · Class II · 2019-06-19 · Ge Healthcare - InterStim(TM) System, Model Numbers: a) TH90G01 b) TH90GFA c) TH90G02 d) TH90G03 Product Usage: The Medtronic Model A510 Clinician applicat…
FDA Device · Class II · 2019-06-19 · Medtronic Neuromodulation - Neff Percutaneous Access Set, Catalog Number NPAS-100-RH-NT
FDA Device · Class II · 2019-06-19 · Cook - Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT)
FDA Device · Class II · 2019-06-19 · Conformis - Silhouette VR This fully integrated system offers intuitive controls with advanced applications for maximum performance all in a space-savi…
FDA Device · Class II · 2019-06-19 · Ge Healthcare - Skytron Integrity 270 Steam Sterilizer and Skytron Integrity 270VP Steam Product Usage: The SKYTRON Integrity 270 Steam Sterilizer for use…
FDA Device · Class II · 2019-06-19 · Skytron Div The Kmw Group - Conformis iTotal Hip Replacement System: HBS-033-00xx-020101, (HIP-PATIENT SPECIFIC STEM RIGHT)
FDA Device · Class II · 2019-06-19 · Conformis - Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420321 Phase 3 Femoral Drill Guide Small
FDA Device · Class II · 2019-06-12 · Zimmer Biomet - Thoracentesis Set, RPN C-THS-850, Order # G03286
FDA Device · Class II · 2019-06-12 · Cook - CyberKnife M6, Part Numbers: a) 0660000: CyberKnife Treatment Delivery System b) 053101-010: CyberKnife M6 FI Treatment Delivery System c)…
FDA Device · Class II · 2019-06-12 · Accuray - Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-421060 Phase 3 Femoral Drill Guide Extra Small
FDA Device · Class II · 2019-06-12 · Zimmer Biomet - ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV19F
FDA Device · Class I · 2019-06-12 · Origen Biomedical - Sterile Nail Clipper Concave Edge (67710)
FDA Device · Class II · 2019-06-12 · Centurion Medical Products - Alinity c Cuvette Segments, List Number 04S47-01 Product Usage: The Alinity c Cuvettes are used on the Alinity c system processing module
FDA Device · Class II · 2019-06-12 · Abbott And Kg - AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generator PG (1) Catalog Number:12740000 UPN: H78712740000 (2) Solero G…
FDA Device · Class II · 2019-06-12 · Angiodynamics Navilyst Medical - NxStage PureFlow B Solution, REF RFP-400, M535RFP4000 Product NxStage PureFlow B Solution is indicated for use with renal replacement thera…
FDA Device · Class II · 2019-06-12 · Nxstage Medical - Sterile Nail Nipper, Barrel Spring (I68400), Sterile
FDA Device · Class II · 2019-06-12 · Centurion Medical Products - Cepheid Xpert SA Nasal Complete Control Panel (Catalog #8196) UDI: 70845357041233 Product Usage: On April 9, 2019, Microbiologics sent ACTI…
FDA Device · Class II · 2019-06-12 · Microbiologics - AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 19cm PG Catalog Number: 700106002 UPN: H7877001060020 (2)…
FDA Device · Class II · 2019-06-12 · Angiodynamics Navilyst Medical - Stryker Heated Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-690, an accessory to the PNEUMO SURE High Flow Insufflator, Dis…
FDA Device · Class II · 2019-06-12 · Stryker - ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV28F
FDA Device · Class I · 2019-06-12 · Origen Biomedical - Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420324Phase 3 Femoral Drill Guide Extra Large
FDA Device · Class II · 2019-06-12 · Zimmer Biomet - ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV32F
FDA Device · Class I · 2019-06-12 · Origen Biomedical - Pericardiocentesis Catheter Set, RPN C-PCS-850, Order # G03282
FDA Device · Class II · 2019-06-12 · Cook - Stryker High Flow II Tube Set, REF 0620-040-660, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile
FDA Device · Class II · 2019-06-12 · Stryker - ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV13F
FDA Device · Class I · 2019-06-12 · Origen Biomedical - Rim Plate, 10-Hole, Left, PRS RX System
FDA Device · Class II · 2019-06-12 · I T S - OMNIBotics iBlock Cutting Guide, 4146-1000 - Product Usage: The OMNIBotics iBlock Cutting Guide is a stainless-steel surgical instrument us…
FDA Device · Class II · 2019-06-12 · Omnilife Science - NxStage PureFlow B Solution, REF RFP-401, M535RPF4010 NxStage PureFlow B Solution is indicated for use with renal replacement therapy syste…
FDA Device · Class II · 2019-06-12 · Nxstage Medical - IntelliVue MX40 Patient Monitor, Product number 865352, Service Numbers All: 453564262571, 453564262591, 453564615311, 453564615331, 453564…
FDA Device · Class II · 2019-06-12 · Philips North America - MRSASelect II, IVD, REF 63758 (20 plates per package)
FDA Device · Class II · 2019-06-12 · Bio Rad Laboratories - AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Generator Refurbished PG Catalog Number: 12740000D UPN: H7871274000…
FDA Device · Class II · 2019-06-12 · Angiodynamics Navilyst Medical - GETINGE MEERA MOBILE OPERATING TABLE: (1) Part 720001B2 (2) Part 720001B0 (3) Part 720001F2 (4) Part 720001F0 (5) Part 710001B2 (6) Part 71…
FDA Device · Class II · 2019-06-12 · Maquet Cardiovascular Us Sales - Stryker High Flow Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-680, an accessory to the PNEUMO SURE High Flow Insufflator,…
FDA Device · Class II · 2019-06-12 · Stryker - IntelliVue MX40 Patient Monitor, Product number 865351, Service Numbers All other countries: 453564451791, 453564451811, 453564467721, 4535…
FDA Device · Class II · 2019-06-12 · Philips North America - Prometra II Programmable Pump (Clinical), Cat
FDA Device · Class II · 2019-06-12 · Flowonix Medical - Stryker Neurovascular, AXS Infinity LS Plus Long Sheath, Rx Only, Sterile EO, USA Customer Service 855-91 NEURO (916-3876): a) REF: INC-111…
FDA Device · Class II · 2019-06-12 · Stryker Neurovascular - ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV23F
FDA Device · Class I · 2019-06-12 · Origen Biomedical - IntelliVue MX40 Patient Monitor, Product number 857146, Service Numbers All: 453564711531 and 453564711541 - Product Usage: Used primarily…
FDA Device · Class II · 2019-06-12 · Philips North America - Prometra Programmer (Grand Prime) Software version 2.00.29, Cat
FDA Device · Class II · 2019-06-12 · Flowonix Medical - Pericardiocentesis Catheter Tray, RPN C-PCYS-850, Order # G03284
FDA Device · Class II · 2019-06-12 · Cook - Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-421930 System Domed Lateral Femoral Drill Guide Sma…
FDA Device · Class II · 2019-06-12 · Zimmer Biomet - Pericardiocentesis Catheter Tray, RPN C-PCSY-850-LHSC-061096, Order # G10030
FDA Device · Class II · 2019-06-12 · Cook - 2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: The 2008T hemodialysis machine is indicat…
FDA Device · Class III · 2019-06-12 · Fresenius Medical Care Renal Therapies Group - MRSASelect, IVD, REF 63747, containing 20 plates per package
FDA Device · Class II · 2019-06-12 · Bio Rad Laboratories - Cepheid Xpert MRSA/MRSA NxG Control Panel (Catalog #8195) UDI: 70845357041226 Product Usage: On April 9, 2019, Microbiologics sent ACTION R…
FDA Device · Class II · 2019-06-12 · Microbiologics - BD Nexiva Dual Port 20GA 1.00IN -Closed IV Catheter System intended for use in the peripheral vascular system Catalog Number: 383536
FDA Device · Class II · 2019-06-12 · Becton Dickinson And - TLS2 Thermal Ligating Shears, Catalog Number 132-131D
FDA Device · Class II · 2019-06-12 · Microline Surgical - AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Applicator 14cm PG Catalog Number: 700106001 UPN:H7877001060010
FDA Device · Class II · 2019-06-12 · Angiodynamics Navilyst Medical - Prometra II Programmable Pump, Cat
FDA Device · Class II · 2019-06-12 · Flowonix Medical - AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 29cm PG Catalog Number:700106003 UPN: H7877001060030 (2)S…
FDA Device · Class II · 2019-06-12 · Angiodynamics Navilyst Medical - Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution
FDA Device · Class II · 2019-06-12 · Kerr Pentron - ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV16F
FDA Device · Class I · 2019-06-12 · Origen Biomedical - CyberKnife VSI, Part Numbers: a) 032500-010: CyberKnife VSI 9.6.x Robotic Radiosurgery System for Japan b) 033000-010: CyberKnife VSI Robot…
FDA Device · Class II · 2019-06-12 · Accuray - Portex Blue Line Ultra Tracheostomy Tube Inner Cannula
FDA Device · Class II · 2019-06-12 · Smiths Medical Asd - Prometra Programmable Pump, Cat
FDA Device · Class II · 2019-06-12 · Flowonix Medical - Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420322 Phase 3 Femoral Drill Guide Medium
FDA Device · Class II · 2019-06-12 · Zimmer Biomet - IntelliVue MX40 Patient Monitor, Product number 865350, Service # USA: 453564262491 and 453564262511 - Product Usage: Used primarily as a t…
FDA Device · Class II · 2019-06-12 · Philips North America - Prometra Clinician Programmer (Touchscreen) Software version 2.00.29, Cat
FDA Device · Class II · 2019-06-12 · Flowonix Medical - Lineum 4.35mm x 28mm Translation Screw, Model No. 14-524728 The Lineum OCT Spine System is intended to provide immobilization and stabiliza…
FDA Device · Class II · 2019-06-12 · Zimmer Biomet - Leica Cryostats, used to produce frozen sample sections for biological, medical and industrial applications, including in-vitro diagnostic…
FDA Device · Class II · 2019-06-12 · Leica Microsystems - Smith Medical JELCO Hypodermic Needle-Pro EDGE Safety Device Safety Device Rx Only Sterile Product Usage: Is a disposable, single use devic…
FDA Device · Class II · 2019-06-12 · Smiths Medical Asd - Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420323 Phase 3 Femoral Drill Guide Large
FDA Device · Class II · 2019-06-12 · Zimmer Biomet - Maquet Getinge-BEQ-TOP 21503 ECC 1/4" AV LOOP Material:701054776
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BO-T 41301 BUMC ECC PACK Material: 701065209
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-T 16405 LIVER TX INFUSION Material:701066097
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Opteform Allograft Disc, 45mm x 5mm, 8cc, Catalog Number 600-03-45
FDA Device · Class II · 2019-06-05 · Exactech - RUSCH LASERTUBE (Rubber), Order No. : 102004-000080, REF 102004, SIZE I.D. mm 8,0
FDA Device · Class II · 2019-06-05 · Teleflex Medical - Maquet Getinge-BO-TOP 35503 SGD PACK Material: 701067668
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge- BEQ-TOP 37200 E-Circuit Bioline Heparin Material: 701055388R01
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-TOP 5103 CPS Tubing Pack Material:701048690R01
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-T 27602 709000417 Adult Custom Pack Material: 709000417
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-T 30914 ECC Pump Pack 1/4" Material: 709000011
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-TOP 31604 CHKD 1/4" ECC Material: 709000518
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-T 30601 CMC ACCESSORY KIT Material: 701064701
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-T 3502 LVAD 1/4" Material: 701068168R01
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Zimmer Biomet Alvarado Knee Holder Base Plate Assembly and Foot Piece, & Alvarado II Base Plate and Foot Piece: Alvarado Foot Piece: Item N…
FDA Device · Class II · 2019-06-05 · Zimmer Surgical - Maquet Getinge-BEQ-TOP 30907 ECC PUMP PACK Material: 701065770
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-TOP 9004 1/4 Custom Pk w/RF32 & HMOD Material: 701054451R01
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BEQ-TOP 21502 ECC Quadrox iD w/RF 3/8" Material:701050060R01
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-T 5220 UAB Hospital Accessory Material: 709000426
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - Maquet Getinge-BO-T 2302 Pediatric Cardiac Surgery Pack Material: 709000006
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular - TactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400 Part Numbers: 600043767 (China), 100154367 (Global), 100154368 (SWA…
FDA Device · Class II · 2019-06-05 · Abbott Laboratories St Jude Medical - SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925, SR-1935, SR-2025, SR-2035, SR-2225, SR-2235, SR-2425, SR-2435
FDA Device · Class I · 2019-06-05 · Terumo Medical - Maquet Getinge-BEQ-T 5211 LARGE ECC SET Material:701064560
FDA Device · Class II · 2019-06-05 · Maquet Cardiovascular
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)