FDA Device · 2018
FDA Device recalls in 2018
RecallRadar indexes 3,757 FDA Device recall notices published in 2018. By classification: 136 Class I, 3,529 Class II, 92 Class III.
- 3.2MM X 510MM COCR THD TIP
FDA Device · Class II · 2018-06-27 · Zimmer Biomet - The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood collection tube that provides a means of collecting, tra…
FDA Device · Class II · 2018-06-27 · Becton Dickinson And - The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood collection tube that provides a means of collecting, tra…
FDA Device · Class II · 2018-06-27 · Becton Dickinson And - G-PIN 2.8BL 3.2PL 98CM 2PK
FDA Device · Class II · 2018-06-27 · Zimmer Biomet - Cryopatch SG Pulmonary Human Cardiac Branch, Catalog Number SGP020
FDA Device · Class II · 2018-06-27 · Cryolife - GUIDE WIRE w/ BALL TIP 2.0MMX98CM
FDA Device · Class II · 2018-06-27 · Zimmer Biomet - P28 JAWS Nitinol Staple System kits are designed for use in an osteotomy, arthrodesis and fragment fixation of bones and joints of the foot…
FDA Device · Class II · 2018-06-27 · Paragon 28 - Fabius GS Premium Anesthesia Machine
FDA Device · Class II · 2018-06-27 · Draeger Medical - C2 CryoBalloon Focal Catheter, REF FG-1009
FDA Device · Class II · 2018-06-27 · Pentax - Fabius GS MRI Anesthesia Machine
FDA Device · Class II · 2018-06-27 · Draeger Medical - CritiCore Automated Urine Output and Temperature Monitor
FDA Device · Class II · 2018-06-27 · C R Bard - The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood collection tube that provides a means of collecting, tra…
FDA Device · Class II · 2018-06-27 · Becton Dickinson And - Olympus JF-140F duodenoscopes (Model NumberJF-140F)
FDA Device · Class II · 2018-06-27 · Olympus - Apollo Anesthesia Machine
FDA Device · Class II · 2018-06-27 · Draeger Medical - Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO
FDA Device · Class II · 2018-06-27 · Cryolife - Olympus JF-160F duodenoscopes (Model NumberJF-160F)
FDA Device · Class II · 2018-06-27 · Olympus - Nitinol Staple, Elastic Staple Large-Symmetrical, Sterile R, Model #: a) ES-18x14
FDA Device · Class II · 2018-06-27 · Trimed - Biograph mCT Systems: (a) Biograph mCT S(64)-3R, Material Number 10248669 Product Usage: The Siemens Biograph mCT and Biograph mCT Flow sys…
FDA Device · Class II · 2018-06-27 · Siemens Medical Solutions Usa - Part no. 690.379, Graphic Case F/6.5mm Cannulated Screw Set
FDA Device · Class II · 2018-06-27 · Synthes Usa Products - Part no. 690.375, Graphic Case F/6.5mm & 7.3mm Combined Cannulated Screw Set
FDA Device · Class II · 2018-06-27 · Synthes Usa Products - Nitinol Staple, Elastic Staple Small-Symmetrical, Sterile R, Model #: a) ES-08x08
FDA Device · Class II · 2018-06-27 · Trimed - BEAD TIP GD WIRE 3.0MM X 60CM
FDA Device · Class II · 2018-06-27 · Zimmer Biomet - Farabeuf Clamp for 3.5mm Screws PRO, Catalog # 705463
FDA Device · Class II · 2018-06-27 · Stryker - Perseus A500 Anesthesia Machine
FDA Device · Class II · 2018-06-27 · Draeger Medical - BALL TIP GUIDE WIRE 2.0MMX60CM
FDA Device · Class II · 2018-06-27 · Zimmer Biomet - Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, REF 74121158 (b) Size 56 mm, REF 74123156
FDA Device · Class II · 2018-06-27 · Smith And Nephew - BALL TIP GUIDE WIRE 3.2MMX55CM
FDA Device · Class II · 2018-06-27 · Zimmer Biomet - Fabius GS Tiro Anesthesia Machine
FDA Device · Class II · 2018-06-27 · Draeger Medical - VNS Therapy Programmer, Model 3000, v1.0 System
FDA Device · Class II · 2018-06-27 · Cyberonics - G-PIN 2.8BL 3.2PL 98CM 2PK
FDA Device · Class II · 2018-06-27 · Zimmer Biomet - Part no. 690.380, Graphic Case F/7.3mm Cannulated Screw Set
FDA Device · Class II · 2018-06-27 · Synthes Usa Products - DRILL PT GUIDE WIRE 3.2MMX98CM, 469360 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullar…
FDA Device · Class II · 2018-06-27 · Zimmer Biomet - BALL TIP GUIDE WIRE 3.2MMX98CM
FDA Device · Class II · 2018-06-27 · Zimmer Biomet - G-PIN 2.8BL 3.2PL 60CM 2PK
FDA Device · Class II · 2018-06-27 · Zimmer Biomet - BioFlo Midline 5F DL-20cm MST-45 Kit w/ Two Nitinol Guidewires PG, Catalog Number 46-810
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical - MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, FILTER, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1116FC
FDA Device · Class II · 2018-06-20 · Sun Med - RS 5F DL BIOFLO PICC, Catalog Number 60M071831
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical - RS 5F DL XPP KIT, Catalog Number 60M183104
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical - Vanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for use in knee joint replacement procedures
FDA Device · Class II · 2018-06-20 · Zimmer Biomet - Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035R01 Product Usage: The Maquet Cardiopulmonary…
FDA Device · Class II · 2018-06-20 · Datascope - cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software controlled analyzer system for in vit…
FDA Device · Class II · 2018-06-20 · Roche Diagnostics - Dimension Vista Gentamicin Flex reagent cartridge, DV GENT, gentamicin enzyme immunoassay
FDA Device · Class II · 2018-06-20 · Siemens Healthcare Diagnostics - BioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit w/70cm Nitinol Wire PG, Catalog Number 75-038
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical - RS 5F DL XPP, Catalog Number 60M030393
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical - Xcela 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-003
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical - IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865351
FDA Device · Class II · 2018-06-20 · Philips Electronics North America - Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-887
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical - Accu-Chek Performa Test Strip, Blood glucose monitoring system, Catalog no. 07299702001 Product Usage: The Accu-Chek Performa test strips a…
FDA Device · Class II · 2018-06-20 · Roche Diabetes Care - RS 5F DL BIOFLO PASV, Catalog Number 60M150373
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical - CAN 5F SINGLE XCELA PICC, Catalog Number 60M701531
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical - Bio-Stable 5F SL-55CM IR-145 Kit Valved with Nitinol GW PG, Catalog Number 45-882
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical - RS 5F DL BIOFLO PASV, Catalog Number 60M183481
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical - Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 4906 PEDIARIC CPB PACK, Part Number 701056041 Product Usage: The Maquet Cardiopulmona…
FDA Device · Class II · 2018-06-20 · Datascope - VIDAS TOXO IgG Avidity is an automated qualitative test for use on the VIDAS family instruments, for the determination of anti-toxoplasma I…
FDA Device · Class II · 2018-06-20 · Biomerieux - RS TANDEM 5F DL BIOFLO PASV, Catalog Number 60M232242
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical - RS 5F DL BIOFLO PASV, Catalog Number 60M132324
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical - smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)
FDA Device · Class II · 2018-06-20 · Smith And Nephew - 5F DL BIOFLO PICC, Catalog Number 60M180592
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical - DermaPro Waterproof Silicone Tape, SNS57232
FDA Device · Class II · 2018-06-20 · Safe N Simple - MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, FILTER AND 7 FT. OXYGEN TUBING, REF CPRM1116F
FDA Device · Class II · 2018-06-20 · Sun Med - BioFlo PICC (NV) 5FDL-55cm Maximal Barrier Nursing Kit w/70cm Nitinol Wire PG, Catalog Number 75-033
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical - MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FILTER, PEEP VALVE, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1126FPC
FDA Device · Class II · 2018-06-20 · Sun Med - MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1126P
FDA Device · Class II · 2018-06-20 · Sun Med - Brilliance 16 with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728240
FDA Device · Class II · 2018-06-20 · Philips Medical Systems Cleveland - The VITEK 2 Neisseria-Haemophilus identification card (NH) is intended for use with the VITEK 2 Systems for the automated identification of…
FDA Device · Class II · 2018-06-20 · Biomerieux - Cell Observer SD, DirectFRAP, Laser TIRF 1, Laser TIRF 2, Laser TIRF3, LightSheet, Elyra, and multiple Laser Scanning Microscopes
FDA Device · Class II · 2018-06-20 · Zeiss Carl - RS - TANDEM 5F DL BIOFLO MIDLINE, Catalog Number 60M035472
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical - CAN 5F DUAL XCELA PICC, Catalog Number 60M701532
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical - Accu-Chek Inform II Test Strip, Whole blood glucose test system, Catalog no. 05942861001 Product Usage: The Accu-Chek Inform II test strips…
FDA Device · Class II · 2018-06-20 · Roche Diabetes Care - Aortic Arterial Cannula 20 Fr (O.D.)
FDA Device · Class II · 2018-06-20 · Maquet Cardiopulmonary Ag - Proteus 235 The PTS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors a…
FDA Device · Class II · 2018-06-20 · Ion Beam Applications - IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865350
FDA Device · Class II · 2018-06-20 · Philips Electronics North America - The VITEK 2 Gram-Positive identification card (GP) is intended for use with the VITEK 2 Systems for the automated identification of most si…
FDA Device · Class II · 2018-06-20 · Biomerieux - Accu-Chek Aviva Plus Test Strip, Blood glucose monitoring system, Catalog nos. 06908217001, 06908268001, 06908349001,06908217001 Product Us…
FDA Device · Class II · 2018-06-20 · Roche Diabetes Care - Part #: SAM XT-C, Model: Hi-Viz Orange or Civilian
FDA Device · Class II · 2018-06-20 · The Seaberg - MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FILTER AND 7 FT. OXYGEN TUBING, REF CPRM1126F
FDA Device · Class II · 2018-06-20 · Sun Med - Color Gram 2 (COLOR GRAM 2 - F), these stains are used to stain bacterial and fungal microorganisms for direct examination, according to th…
FDA Device · Class II · 2018-06-20 · Biomerieux - Part #: SAM XT-M, Model: Tactical Black or Military
FDA Device · Class II · 2018-06-20 · The Seaberg - 12C
FDA Device · Class II · 2018-06-20 · Ion Beam Applications - MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1126C
FDA Device · Class II · 2018-06-20 · Sun Med - Bio-Stable 5F SL-55CM IR-145 Kit Valved PG, Catalog Number 45-818
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical - BioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-019
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical - CAN 5F DL BIOFLO PASV PICC NURSING TRAY, Catalog Number 60M700936
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical - Aortic Arterial Cannula 24 Fr (O.D.)
FDA Device · Class II · 2018-06-20 · Maquet Cardiopulmonary Ag - Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic x-ray system device intended to be used for the radiography in…
FDA Device · Class II · 2018-06-20 · Shimadzu Medical Systems - The PREVI¿ Color Gram dyes are used with the PREVI¿ Color Gram instrument to stain bacterial and fungal microorganisms for direct examinati…
FDA Device · Class II · 2018-06-20 · Biomerieux - XCELA PASV 5F SL 55CM IR-145 Nitinol Wire KIT PG, Catalog Number 25-124
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical - Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved with Nitinol Guidewire PG, Catalog Number 45-895
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical - The VITEK¿ 2 Anaerobic and Corynebacteria identification card (ANC) is intended for use with the VITEK¿ 2 Systems for the automated identif…
FDA Device · Class II · 2018-06-20 · Biomerieux - CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: CellaVision DM96, DM1200, DM9600 and DI-60 Product Usa…
FDA Device · Class II · 2018-06-20 · Cellavision Ab - remel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH W/OXACILLIN Product Usage: Recommended for the use in qualitat…
FDA Device · Class II · 2018-06-20 · Thermo Fisher - MEDLINE ADULT MANUAL RESUSCITATOR WITH LARGE ADULT MASK, TUBE RESERVOIR, FILTER AND 7 FT. OXYGEN TUBING, REF CPRM1126FL
FDA Device · Class II · 2018-06-20 · Sun Med - MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1116P
FDA Device · Class II · 2018-06-20 · Sun Med - Bio-Stable 5F SL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-886
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical - Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, Catalog Number 45-871
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical - MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, PEEP VALVE, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1116PC
FDA Device · Class II · 2018-06-20 · Sun Med - Biomet Modular Primary Tibial Tray Implants
FDA Device · Class II · 2018-06-20 · Zimmer Biomet - The VITEK¿ 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to…
FDA Device · Class II · 2018-06-20 · Biomerieux - Oxidase Reagent (ref: 55635): This test is used to detect the production of the enzyme cytochrome oxidase by bacteria
FDA Device · Class II · 2018-06-20 · Biomerieux - IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 867146
FDA Device · Class II · 2018-06-20 · Philips Electronics North America
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)