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.
- XLTEK EMU40EX EEG Headbox
FDA Device · Class II · 2018-08-08 · Natus Neurology - Final Pack, Esteem II, Sound Processor Model 2001, containing 2 Sterile Wipes 002866-001 (which expired in April 2018)
FDA Device · Class II · 2018-08-08 · Envoy Medical - VIDAS LH, Reference Numbers 30406 and 30406-01
FDA Device · Class II · 2018-08-08 · Biomerieux - Zimmer Dermatone AN, Model No. 88710100
FDA Device · Class II · 2018-08-08 · Zimmer Surgical - VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2
FDA Device · Class II · 2018-08-08 · Livanova Usa - Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-540
FDA Device · Class III · 2018-08-08 · Diamedix - SOMATOM Perspective (Model 10495568)
FDA Device · Class II · 2018-08-08 · Siemens Medical Solutions Usa - Discovery RT labeled as: a. MID BJG
FDA Device · Class II · 2018-08-08 · Ge Healthcare - EZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use
FDA Device · Class II · 2018-08-08 · Qiagen - CT Goldseal BrightSpeed 16 PWR TIO 2 YR
FDA Device · Class II · 2018-08-08 · Ge Healthcare - Nicolet¿ Ambulatory EEG
FDA Device · Class II · 2018-08-08 · Natus Neurology - SOMATOM Emotion 16 (10165977)
FDA Device · Class II · 2018-08-08 · Siemens Medical Solutions Usa - power cord for: (a) AMIA Automated PD Cycler, Product Code: 5C9320
FDA Device · Class II · 2018-08-08 · Baxter Healthcare - Percutaneous Sheath Introducer Kit for use with 7 - 7.5 Fr. Catheters (8 Fr. 10 cm sheath length .035 inch dia. spring-wire guide), REF ES-…
FDA Device · Class II · 2018-08-08 · Arrow International - Optima CT 540
FDA Device · Class II · 2018-08-08 · Ge Healthcare - OMNI Hip System, ApeX-LNK Acetabular Inserts 0 degree, 4+mm offset, Product Codes: H6-14436, H6-13928 & H6-14836 Product Usage: The Apex Hi…
FDA Device · Class II · 2018-08-01 · Omnilife Science - PDS Plus Antibacterial (Polydioxanone) Suture-PDS PLUS Undyed Suture 45cm (18") 4-0 Single Armed PS-4 Prime Needle Product Code: PDP507G (G…
FDA Device · Class II · 2018-08-01 · Ethicon - BLAST Bandage, sterile
FDA Device · Class II · 2018-08-01 · Tactical Medical Solutions - Gibco RPMI 1640 Medium, Model Number 61870150
FDA Device · Class II · 2018-08-01 · Life Technologies - UNIQ Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invas…
FDA Device · Class II · 2018-08-01 · Philips Healthcare - 2M insert 15degree for MUTARS RS cup and LUMiC TiN orthopedic hip implant acetabular component
FDA Device · Class II · 2018-08-01 · Implantcast - RayStation Radiation Therapy Treatment Planning System, Model nos. 2.5, 3.5, 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 7.0 Product Usage…
FDA Device · Class II · 2018-08-01 · Raysearch Laboratories Ab - Uretero-reno videoscope URF-V2 Uretero-reno videoscope URF-V2R
FDA Device · Class II · 2018-08-01 · Olympus - Leica Microsystems products labeled as the following: Leica M320 Microscope Systems with Article Numbers 10448419, 10448420, 10448485, 1044…
FDA Device · Class II · 2018-08-01 · Leica Microsystems - Tubing Pack Convenience Kit, Product Code 65217 Product Usage: Intended for use only in the extracorporeal circuit of the cardiopulmonary b…
FDA Device · Class II · 2018-08-01 · Terumo Cardiovascular Systems - Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, Model Number 11965175
FDA Device · Class II · 2018-08-01 · Life Technologies - Artis zee systems with Laird Cooling Unit for SSFD: Material # 7555118
FDA Device · Class II · 2018-08-01 · Siemens Medical Solutions Usa - Gibco CTS OpTmizer T Cell Expansion Serum Free Medium, bag format, Model Numbers A1048503 and A1022103
FDA Device · Class II · 2018-08-01 · Life Technologies - Vivo 65, Continuous Ventilator, Home Use, Cat
FDA Device · Class III · 2018-08-01 · Human Design Medical - PDS Plus Antibacterial Suture-PDS PLUS Undyed Suture 45cm (18") 5-0 Single Armed P-3 Prime Needle Product Code: PDP493G (GTIN 1070503120394…
FDA Device · Class II · 2018-08-01 · Ethicon - BioGlue Spreader Tip, 12mm, Sterile, RX Only
FDA Device · Class II · 2018-08-01 · Cryolife - PR4100 Microplate Reader US, Catalog Number 45591587 Product Usage: The PR4100 Microplate Reader is a 96 well absorbance reader for the mea…
FDA Device · Class II · 2018-08-01 · Bio Rad Laboratories - CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511
FDA Device · Class II · 2018-08-01 · Depuy Orthopaedics - Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model Number 11995123
FDA Device · Class II · 2018-08-01 · Life Technologies - GIBCO CTS AIM V Serum-Free Media (SFM), Model Number 0870112BK. Tissue and cell culture medium
FDA Device · Class II · 2018-08-01 · Life Technologies - Prevent G Safety Winged Blood Collection Set Glide - Sterile/EO
FDA Device · Class II · 2018-08-01 · Guangzhou Improve Medical Instruments - AperFix Femoral Implant Coring Removal Drill, labeled as the following: a. Femoral Removal Coring Reamer 9mm, Model Number CM-7109
FDA Device · Class II · 2018-08-01 · Cayenne Medical - Brivo XR385, model 5215463, Digital Diagnostic Radiographic System
FDA Device · Class II · 2018-08-01 · Ge Healthcare - Arctic Sun Temperature Management System, Model 5000
FDA Device · Class II · 2018-08-01 · Bard Medical Division - PDS II (Polydioxanoe) Suture Dyed & Undyed-PDSII Undyed 45cm (18") 5-0 Single Armed PS-6 Prime Needle Product Code: Z511G (GTIN 10705031061…
FDA Device · Class II · 2018-08-01 · Ethicon - HexaPOD evo RT Couch Top (also known as HexaPOD evo Module), a component of the HexaPOD evo RT system
FDA Device · Class II · 2018-08-01 · Elekta - MR Surgical Suite Option Product The MR Surgical Option when integrated with the GE Signa¿ 3.0T or 1.5T magnetic resonance scanner (previou…
FDA Device · Class II · 2018-08-01 · Ge Medical Systems - ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-uni…
FDA Device · Class II · 2018-08-01 · Implant Direct Sybron Manufacturing - Centron Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally in…
FDA Device · Class II · 2018-08-01 · Philips Healthcare - Uretero-reno fiberscope URF-P6
FDA Device · Class II · 2018-08-01 · Olympus - Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model Number 11995115
FDA Device · Class II · 2018-08-01 · Life Technologies - CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital Electronics System,…
FDA Device · Class II · 2018-08-01 · Abbott Laboratories - ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000
FDA Device · Class II · 2018-08-01 · Siemens Medical Solutions Usa - Allura Xper Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimall…
FDA Device · Class II · 2018-08-01 · Philips Healthcare - AXIOM Artis with Laird Cooling Unit for SSFD: Material # 7555118
FDA Device · Class II · 2018-08-01 · Siemens Medical Solutions Usa - Patient Positioning System with KRC2 controller using software versions 2.3.1 2.3.10 Product Usage: The patient positioning system is a SCA…
FDA Device · Class II · 2018-08-01 · Forte Automation Systems - cobas m 511 integrated hematology analyzer, Model Number 07261691190 Product Usage: The cobas m 511 integrated hematology analyzer is a qua…
FDA Device · Class II · 2018-08-01 · Roche Diagnostics Hematology - Uretero-reno fiberscope URF-P6RP6
FDA Device · Class II · 2018-08-01 · Olympus - Access Hi-Low Exam Tables, Model 6501-XX
FDA Device · Class II · 2018-08-01 · Brewer - Nobel Biocare 17¿ Multi-Unit Abutment, Conical Connection NP, 2.5mm, REF 36614
FDA Device · Class II · 2018-08-01 · Nobel Biocare Usa - AD-TECH Medical Instrument Corporation Drill Sleeve Guides DSG-6-3-090-2.4N utilizing raw material (RM0677) from the following lots from ve…
FDA Device · Class II · 2018-08-01 · Ad Tech Medical Instrument - Invia Motion Negative Pressure Wound Therapy System
FDA Device · Class II · 2018-08-01 · Medela - Hydroline Trumpet Valve, Trumpet Valve, 5mm x 28cm Probe, Double Spike, Ref ASU1211, packaged 1/box, 12 boxes/case, single use, RX, Sterile
FDA Device · Class II · 2018-07-25 · Cardinal Health 200 - Vectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation, Models: (a) 977D160 (b) 977D260 Product Usage: The Medtronic Vectris lead…
FDA Device · Class II · 2018-07-25 · Medtronic Neuromodulation - PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
FDA Device · Class II · 2018-07-25 · Ethicon - Dimension Vista¿ MULTI 1 SDIL, KD693, SMN# 10469971
FDA Device · Class II · 2018-07-25 · Siemens Healthcare Diagnostics - MX-10 surveillance laser system Product Usage: The expected usage of the product is to facilitate observation and surveillance missions fro…
FDA Device · Class II · 2018-07-25 · Wescam - PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
FDA Device · Class II · 2018-07-25 · Ethicon - Presource PBDS, Kit, Common
FDA Device · Class II · 2018-07-25 · Cardinal Health 200 - Ingenuity Digital PET/CT System, Model 882446 with the following UDI's: (01)00884838059559(21)900004 (01)00884838059559(21)900005 (01)00884…
FDA Device · Class II · 2018-07-25 · Philips Medical Systems Cleveland - Health Harmony Mobile application software Product Usage: Care Innovations Health Harmony Mobile is intended as a communication tool to dis…
FDA Device · Class II · 2018-07-25 · Intel Ge Care Innovations - RayStation stand-alone software treatment planning system, RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), RayStation 5, RaySta…
FDA Device · Class II · 2018-07-25 · Raysearch Laboratories Ab - Hydroline Trumpet Valve, Trumpet Valve, 5mm x 33cm Probe, Single Spike, Ref ASU1200, packaged 1/box, 12 boxes/case, single use, RX, Sterile
FDA Device · Class II · 2018-07-25 · Cardinal Health 200 - Dimension Vista¿ CTNI Sample Diluent, KD692, SMN# 10445205
FDA Device · Class II · 2018-07-25 · Siemens Healthcare Diagnostics - Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling system 45 mm Vascular/Medium, Item Code SIG45ACTAVM
FDA Device · Class II · 2018-07-25 · Covidien Medtronic - Tri-Staple 2.0 Intelligent Reload for use with Signia stapling system 30 mm Medium/Thick, Item Code SIG30AMT
FDA Device · Class II · 2018-07-25 · Covidien Medtronic - Hydroline Trumpet Valve, Trumpet Valve, No Probe, Single Spike, Ref ASU1220, packaged 1/box, 12 boxes/case, single use, RX, Sterile
FDA Device · Class II · 2018-07-25 · Cardinal Health 200 - PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
FDA Device · Class II · 2018-07-25 · Ethicon - PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
FDA Device · Class II · 2018-07-25 · Ethicon - Presource PBDS, Kit, Common Diabetes
FDA Device · Class II · 2018-07-25 · Cardinal Health 200 - Fx SOLUTIONS CENTERED HEAD CoCr 50x19, REF 106-5019 Product Usage: Device is designed to produce and deliver proton beam for the treatment…
FDA Device · Class II · 2018-07-25 · Fx Solutions - Presource PBDS, Kit, No Spiro Diabetes
FDA Device · Class II · 2018-07-25 · Cardinal Health 200 - Presource PBDS, Kit, No Spiro
FDA Device · Class II · 2018-07-25 · Cardinal Health 200 - Tri-Staple 2.0 Black Intelligent Reload for use with Signia stapling system 60 mm Extra Thick, Item Code SIG60AXT
FDA Device · Class II · 2018-07-25 · Covidien Medtronic - Apollo XT Suture Anchor, 5.5 x 15 Product Usage: Apollo XT Suture Anchors are intended for: Shoulder - Rotator Cuff Repair - Bankart Repair…
FDA Device · Class II · 2018-07-25 · Valeris Medical - TIBIAXYS, Model Numbers: 150010S, 150020S, 150030S, 150040S, 150120S, 150110S, 150130S, 150200S, 150240S, 150242S, 150246S, 150250S, 150255…
FDA Device · Class II · 2018-07-25 · Newdeal - PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
FDA Device · Class II · 2018-07-25 · Ethicon - Reprocessed HARMONIC Ace¿ +7, 5mm Diameter Shears with Advanced Hemostasis (HARH), Item Number HARH36 Product Usage: The Reprocessed HARMON…
FDA Device · Class II · 2018-07-25 · Stryker Sustainability Solutions - ADVANSYS MLP/DLP, Model Numbers: 181051S, 181052S, 181041S, 181042S, 181031S, 181032S, 181033S, 181021S, 181022S & 181023S
FDA Device · Class II · 2018-07-25 · Newdeal - PRONOVA SUTURE BLUE 122CM M1.5, D10189
FDA Device · Class II · 2018-07-25 · Ethicon - Hydroline Trumpet Valve, Trumpet Valve, 5mm x 33cm Probe, Double Spike, Ref ASU1201, packaged 1/box, 12 boxes/case, single use, RX, Sterile
FDA Device · Class II · 2018-07-25 · Cardinal Health 200 - Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Cassette, 5mm x 33cm Composite Probe, Double Spike, Ref ASC1201, packa…
FDA Device · Class II · 2018-07-25 · Cardinal Health 200 - UNI-CP, Model Numbers: 330021S, 330023S, 330025S, 330030S, 330025S, 30030S, 330217S, 330220S, 330225S, 330230S, 330420S, 330425S, & 330430S
FDA Device · Class II · 2018-07-25 · Newdeal - Endo GIA 45 mm Articulating Vascular/Medium Loading Unit with Tri-Staple Technology, Item Code EGIA454AVM
FDA Device · Class II · 2018-07-25 · Covidien Medtronic - PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
FDA Device · Class II · 2018-07-25 · Ethicon - Vectris(TM) Sure Scan(R) MRI Lead Kit for Spinal Cord Stimulation, Models: (a) 977A160 (b) 977A175 (c) 977A190 (d) 977A260 (e) 977A275 (f)…
FDA Device · Class II · 2018-07-25 · Medtronic Neuromodulation - Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Cassette, 5mm x 33cm Composite Probe, Single Spike, Ref ASC1200, packa…
FDA Device · Class II · 2018-07-25 · Cardinal Health 200 - PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
FDA Device · Class II · 2018-07-25 · Ethicon - Disinfection unit UV (432332-9020-000) for the Celldiscoverer 7 microscope
FDA Device · Class II · 2018-07-25 · Zeiss Carl - PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
FDA Device · Class II · 2018-07-25 · Ethicon - Endo GIA 45 mm Articulating Medium/Thick Reload with Tri-Staple Technology, Item Code EGIA45AMT
FDA Device · Class II · 2018-07-25 · Covidien Medtronic - Endo GIA 60 mm Articulating Vascular/Medium Loading Unit with Tri-Staple Technology, Item Code EGIA60AVM
FDA Device · Class II · 2018-07-25 · Covidien Medtronic - AesDex, LLC Cardica C-Port xA PLUS Anastomosis System
FDA Device · Class II · 2018-07-25 · Aesdex - Dimension Vista¿ MULTI 2 SDIL, KD694, SMN# 10483586
FDA Device · Class II · 2018-07-25 · Siemens Healthcare Diagnostics - PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
FDA Device · Class II · 2018-07-25 · Ethicon
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)