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.
- Terumo Needle, 30G x 1/2", Product Code NN3013R
FDA Device · Class II · 2019-07-31 · Terumo Medical - Artis zeego, Model Number 10280959
FDA Device · Class II · 2019-07-31 · Siemens Medical Solutions Usa - Artis zee multi, Model Number 10094139
FDA Device · Class II · 2019-07-31 · Siemens Medical Solutions Usa - IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator
FDA Device · Class II · 2019-07-31 · Medical Intelligence Medizintechnik - Terumo Sur-vet Needle, 22G x 3/4", Product Code 100279
FDA Device · Class II · 2019-07-31 · Terumo Medical - C3 is an in vitro diagnostic assay for the quantitative determination of C3 in human serum or plasma
FDA Device · Class II · 2019-07-31 · Abbott Laboratories - Terumo Sur-vet Needle, 25G x 5/8", Product Code 100220
FDA Device · Class II · 2019-07-31 · Terumo Medical - Terumo Sur-vet Needle, 25G x 5/8", Product Code 100280
FDA Device · Class II · 2019-07-31 · Terumo Medical - AXIOM Artis dBA, Model Number 7555357
FDA Device · Class II · 2019-07-31 · Siemens Medical Solutions Usa - AXIOM Artis BA, Model Number 5904656
FDA Device · Class II · 2019-07-31 · Siemens Medical Solutions Usa - The,K -ASSAY HP assay is intended for the quantitative determination of human haptoglobin by immunoturbidimetric assay
FDA Device · Class II · 2019-07-31 · Abbott Laboratories - Monoject Blunt Cannula, 15 G x 1-1/2" (1.829 mm x 3.8 cm) Item code: 8881202314
FDA Device · Class II · 2019-07-31 · Cardinal Health 200 - MAC VU360, Model Number 2030360-001, Electrocardiograph
FDA Device · Class II · 2019-07-31 · Ge Healthcare - AXIOM Artis dFC, Model Number 7412807
FDA Device · Class II · 2019-07-31 · Siemens Medical Solutions Usa - Zyno Medical Administration Set -105"ADMIN SET 20DP W/FILTER 2YSITES CLMP- For Use with Zyno Medical Infusion pumps or Gravity Feed Product…
FDA Device · Class II · 2019-07-31 · Zyno Medical - Artis zee floor, Model Number 10094135
FDA Device · Class II · 2019-07-31 · Siemens Medical Solutions Usa - Terumo Sur-vet Needle, 20G x 1", Product Code 100204
FDA Device · Class II · 2019-07-31 · Terumo Medical - GammaPod Stereotactic Radiotherapy System Model A, REF XMSGP030A00-0.02 Product Usage: GammaPod is a teletherapy device intended for use in…
FDA Device · Class II · 2019-07-31 · Xcision Medical Systems - AXIOM Artis dFC, Model Number 7727717
FDA Device · Class II · 2019-07-31 · Siemens Medical Solutions Usa - AXIOM Artis TA, Model Number 7007755
FDA Device · Class II · 2019-07-31 · Siemens Medical Solutions Usa - Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code: 8881200037
FDA Device · Class II · 2019-07-31 · Cardinal Health 200 - Artis zee biplane MN, Model Number 10094143
FDA Device · Class II · 2019-07-31 · Siemens Medical Solutions Usa - RX Imola, Model Nos
FDA Device · Class II · 2019-07-31 · Randox Laboratories - AXIOM Artis MP, Model Number 5904466
FDA Device · Class II · 2019-07-31 · Siemens Medical Solutions Usa - Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1
FDA Device · Class II · 2019-07-31 · Merge Healthcare - PulsioFlex Monitoring System, Part Number: 6882747, Model Number: PC400 3 R0. Usage: The PulsioFlex Monitoring System is indicated in patie…
FDA Device · Class II · 2019-07-31 · Getinge Us Sales - U3-3 Solar Blue, Laptop integrated power supply used with the Solar Blue Urodynamics for assessing lower urinary tract dysfunctions
FDA Device · Class II · 2019-07-31 · Laborie Medical Technologies - 3mL Safety-Lok Syringe, Catalog Number 309606, UDI 30382903096061
FDA Device · Class II · 2019-07-31 · Becton Dickinson And - Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code:8881200045
FDA Device · Class II · 2019-07-31 · Cardinal Health 200 - VITALE Silicon Foam Dressings 4"x4" Cat
FDA Device · Class II · 2019-07-31 · Cellera - Monoject Standard Hypodermic Needle Item code: 8881200029
FDA Device · Class II · 2019-07-31 · Cardinal Health 200 - Monoject 201 Vet Pak Hypodermic Needle, 20 ga x 1-1/2" Item code: 8881201498
FDA Device · Class II · 2019-07-31 · Cardinal Health 200 - ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT BNP Controls are for the estimation of test precision and the detection of systematic a…
FDA Device · Class III · 2019-07-31 · Abbott Laboratories - RX Daytona, Model Nos
FDA Device · Class II · 2019-07-31 · Randox Laboratories - AXIOM Artis FA, Model Number 5904441
FDA Device · Class II · 2019-07-31 · Siemens Medical Solutions Usa - POWERPORT CLEARVUE isp, 6F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit
FDA Device · Class II · 2019-07-31 · Bard Peripheral Vascular - AXIOM Artis dBC, Model Number 5917054
FDA Device · Class II · 2019-07-31 · Siemens Medical Solutions Usa - LEEP Precision Integrated System 120V & LEEP Precision Generator, Model Nos
FDA Device · Class II · 2019-07-31 · Coopersurgical - Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1
FDA Device · Class II · 2019-07-31 · Merge Healthcare - Terumo Sur-vet Needle, 22G x 1", Product Code 100211
FDA Device · Class II · 2019-07-31 · Terumo Medical - BrightView XCT , Model Number 882482
FDA Device · Class II · 2019-07-31 · Philips Medical Systems Cleveland - Monoject 201 Vet Pak Hypodermic Needle, 18 ga x 1-1/2 Item code: 8881201548
FDA Device · Class II · 2019-07-31 · Cardinal Health 200 - Terumo Needle, 18G x 1", Product Code NN1825R
FDA Device · Class II · 2019-07-31 · Terumo Medical - Monoject Standard Hypodermic Needle, 20 G x 1-1/2" bulk Item code: 8881200664
FDA Device · Class II · 2019-07-31 · Cardinal Health 200 - STANLEY Healthcare Arial 54315 Network Manager
FDA Device · Class II · 2019-07-31 · Stanley Security Solutions - Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile ED, REF 181-2112, RX, (01) 108187880213945, LOT 31…
FDA Device · Class II · 2019-07-31 · Epimed International - Immunoglobulin G is an in vitro diagnostic assay for the quantitative determination of immunoglobulin G in human serum or plasma
FDA Device · Class II · 2019-07-31 · Abbott Laboratories - Terumo Sur-vet Needle, 22G x 3/4", Product Code 100215
FDA Device · Class II · 2019-07-31 · Terumo Medical - Nimbus Administration Set, REF HS-004, UDI # 00817170020031 Product Usage: Administer fluids/medication from a container to a patient throu…
FDA Device · Class II · 2019-07-31 · Infutronix - Immunoglobulin A is an in vitro diagnostic assay for the quantitative determination of immunoglobulin A in human serum or plasma
FDA Device · Class II · 2019-07-31 · Abbott Laboratories - AXIOM Artis dFA, Model Number 7555373
FDA Device · Class II · 2019-07-31 · Siemens Medical Solutions Usa - Monoject Blunt Cannula, 22 G x 1-1/2" (0.711 mm x 3.8 cm) Item code: 8881202389
FDA Device · Class II · 2019-07-31 · Cardinal Health 200 - AXIOM Artis dMP, Model Number 7555365
FDA Device · Class II · 2019-07-31 · Siemens Medical Solutions Usa - Monoject 201 Vet Pak Hypodermic Needle, 19 ga x 1-1/2 Item code: 8881201522
FDA Device · Class II · 2019-07-31 · Cardinal Health 200 - C4 is an in vitro diagnostic assay for the quantitative determination of C4 in human serum or plasma
FDA Device · Class II · 2019-07-31 · Abbott Laboratories - Monoject Blunt Cannula, 19 G x 1-1/2" (1.067 mm x 3.8 cm) Item code: 8881202355
FDA Device · Class II · 2019-07-31 · Cardinal Health 200 - AXIOM Artis FC, Model Number 5904433
FDA Device · Class II · 2019-07-31 · Siemens Medical Solutions Usa - Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile ED, REF 181-2112, RX, (01) 108187880213945, LOT 31…
FDA Device · Class II · 2019-07-31 · Epimed International - Breast Milk Transfer Lid for use with Oral Syringe Connectors Model: 90003S-100
FDA Device · Class III · 2019-07-31 · Medela - Monoject 201 Vet Pak Hypodermic Needle, 22 ga x 1-1/2" Item code: 8881201456
FDA Device · Class II · 2019-07-31 · Cardinal Health 200 - AXIOM Artis TC, Model Number 7728350
FDA Device · Class II · 2019-07-31 · Siemens Medical Solutions Usa - BrightView SPECT, Model Number 882480
FDA Device · Class II · 2019-07-31 · Philips Medical Systems Cleveland - Monoject Blunt Cannula, 16 G x 1-1/2" (1.651 mm x 3.8 cm) Item code: 8881202322
FDA Device · Class II · 2019-07-31 · Cardinal Health 200 - ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibrators are for the calibration of the ARCHITECT iSystem when used for the q…
FDA Device · Class III · 2019-07-31 · Abbott Laboratories - AXIOM Artis BC, Model Number 5904649
FDA Device · Class II · 2019-07-31 · Siemens Medical Solutions Usa - Apolipoprotein A1 is an in vitro diagnostic assay for the quantitative determination of apolipoprotein A1 in human serum or plasma
FDA Device · Class II · 2019-07-31 · Abbott Laboratories - Artis zee ceiling, Model Number 10094137
FDA Device · Class II · 2019-07-31 · Siemens Medical Solutions Usa - AXIOM Artis dTA, Model Number 7008605
FDA Device · Class II · 2019-07-31 · Siemens Medical Solutions Usa - BrightView X , Model Number 882478
FDA Device · Class II · 2019-07-31 · Philips Medical Systems Cleveland - Monoject Blunt Cannula, 20 G x 1-1/2" (0.902 mm x 3.8 cm) Item code: 8881202363
FDA Device · Class II · 2019-07-31 · Cardinal Health 200 - Apolipoprotein B is an in vitro diagnostic assay for the quantitative determination of apolipoprotein B in human serum or plasma
FDA Device · Class II · 2019-07-31 · Abbott Laboratories - AXIOM Artis dTC, Model Number 7413078
FDA Device · Class II · 2019-07-31 · Siemens Medical Solutions Usa - Terumo Needle, 23G x 1", Product Code NN2325R
FDA Device · Class II · 2019-07-31 · Terumo Medical - Monoject Standard Hypodermic Needle, 14 G x 1-1/2" Item code: 8881200011
FDA Device · Class II · 2019-07-31 · Cardinal Health 200 - MOOG Curlin Infusion Administration Set, REF 340-4130, Non-DEHP Tubing with Non-Vented Bag Spike and Vented 0.2 Micron Filter, packaged 20…
FDA Device · Class II · 2019-07-31 · Zevex Dba Moog Medical Devices Group - Zyno Medical Administration Set -105"ADMIN SET 20DP, W/2 Y SITE, CVCLMPS- For Use with Zyno Medical Infusion pumps or Gravity Feed Product…
FDA Device · Class II · 2019-07-31 · Zyno Medical - Artis zee floor MN, Model Number 10094142
FDA Device · Class II · 2019-07-31 · Siemens Medical Solutions Usa - Artis zee biplane, Model Number 10094141
FDA Device · Class II · 2019-07-31 · Siemens Medical Solutions Usa - Erisma- LP posterior fixation system with the below specifically affected products: 1. Erisma-LP polyaxial screws - 4.5, 5.5, 6.5, 7.5, 8.5…
FDA Device · Class III · 2019-07-24 · Clariance - TAPSYSTEM Model 2A, REF 8002A
FDA Device · Class III · 2019-07-24 · Cardiocommand - Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish RIC-5-9-D REALTIME 4D
FDA Device · Class II · 2019-07-24 · Ge Healthcare - Advincula Delineator with Ultem Plastic Soft Cup size 2.5 cm
FDA Device · Class II · 2019-07-24 · Coopersurgical - Comprehensive Reverse Shoulder Instrument Case Outer (Outer Case Vault Only), Item Number 595509
FDA Device · Class II · 2019-07-24 · Zimmer Biomet - Ultra-Drive Hose/Drape Assembly, Reference Number 423833 - Product Usage: Item used with the UltraDrive System to provide proper irrigation…
FDA Device · Class II · 2019-07-24 · Zimmer Biomet - BD Microtainer Tube w/ BD Microgard Closure, K2EDTA additive, Model Numbers 365974 and 365975 Product Usage: The Microtainer¿ Brand Tube wi…
FDA Device · Class II · 2019-07-24 · Becton Dickinson And - CS100 Intra-Aortic Balloon Pump, English, 220V
FDA Device · Class I · 2019-07-24 · Datascope - Advincula Delineator with Ultem Plastic Soft Cup size 3.0 cm
FDA Device · Class II · 2019-07-24 · Coopersurgical - Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories, Part Number 0684-00-0568-01 Product Usage: The Sensation Plus 7.…
FDA Device · Class II · 2019-07-24 · Datascope - Alpha Conducting solution product codes:3310-15 ACS - Product Usage: Electrode conductivity spray solution
FDA Device · Class II · 2019-07-24 · Pharmaceutical Innovations - ElectroMist product codes: 36-3310-04 - Product Usage: Electrode Conductivity Spray Solution
FDA Device · Class II · 2019-07-24 · Pharmaceutical Innovations - Olympus WM-NP2 or WM-DP2 Mobile Workstations with Nurse Control Panel Arm, Model
FDA Device · Class II · 2019-07-24 · Olympus - ElectroMist product codes: 36-3310-60 - Product Usage: Electrode Conductivity Spray Solution
FDA Device · Class II · 2019-07-24 · Pharmaceutical Innovations - RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection device
FDA Device · Class III · 2019-07-24 · Teleflex Medical - Ultra-Drive Irrigation Tubing Assembly, Reference Number 423834 - Product Usage: Item used with the UltraDrive System to provide proper irr…
FDA Device · Class II · 2019-07-24 · Zimmer Biomet - Cardiosave Rescue IABP, 0998-00-0800-83 Intra-Aortic Balloon Pump For cardiovascular use
FDA Device · Class I · 2019-07-24 · Datascope - The Tina-quant lgA Gen.2 is an immunoturbidimetric assay
FDA Device · Class II · 2019-07-24 · Roche Diagnostics - ElectroMist product codes: 36-3310-25 - Product Usage: Electrode conductivity spray solution
FDA Device · Class II · 2019-07-24 · Pharmaceutical Innovations - CS300 Intra-Aortic Balloon Pump, English, 220V
FDA Device · Class I · 2019-07-24 · Datascope - Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc. for the following software devices: (A) Kaluza C Perpetual L…
FDA Device · Class II · 2019-07-24 · Beckman Coulter - Comprehensive Reverse Shoulder Instrument Case Total (Outer Case Vault Only), Item Number 595510
FDA Device · Class II · 2019-07-24 · Zimmer Biomet
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)