FDA Device · 2020
FDA Device recalls in 2020
RecallRadar indexes 3,055 FDA Device recall notices published in 2020. By classification: 182 Class I, 2,804 Class II, 69 Class III.
- EPIDURAL CATHETERIZATION KIT, Product Code IT-05400-DC
FDA Device · Class II · 2020-02-19 · Arrow International - Terumo Advanced Perfusion Assembly Pump Guts, 6 Inch, Catalog Number 801798 - is indicated for use for up to 6 hours in the extracorporeal…
FDA Device · Class II · 2020-02-19 · Terumo Cardiovascular Systems - EPIDURAL CATHETERIZATION KIT, Product Code AT-05501-LEO
FDA Device · Class II · 2020-02-19 · Arrow International - Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthroplasty Catalog Refer…
FDA Device · Class II · 2020-02-19 · Blue Ortho - Terumo AZUR Peripheral Coil System, Detachable 35, Framing Coil, REF numbers 45-651026 and 45-652050, Sterile, Rx. The firm name on the lab…
FDA Device · Class II · 2020-02-19 · Microvention - SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708
FDA Device · Class II · 2020-02-19 · Implant Direct Sybron Manufacturing - Epidural Catheterization Kit with FlexTip Plus Catheter, Product Code TI-05520-EPI
FDA Device · Class II · 2020-02-19 · Arrow International - Loop-Style Tocotransducer (Nautilus) 2264LAX, that may have been serviced with the following: Pacific Medical GE Corometrics Nautilus Toco…
FDA Device · Class II · 2020-02-19 · Pacific Medical Group - Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467
FDA Device · Class II · 2020-02-19 · Nextremity Solutions - Terumo Advanced Perfusion System 1 Roller Pump, 6 Inch, Catalog Number 816571 - Product Usage: is indicated for use for up to 6 hours in th…
FDA Device · Class II · 2020-02-19 · Terumo Cardiovascular Systems - Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog: Number A24200010
FDA Device · Class II · 2020-02-19 · Medicrea International - FlexTip Plus Epidural Catheterization Kit, Product Code JC-05400-E
FDA Device · Class II · 2020-02-19 · Arrow International - FlexTip Plus Epidural Catheterization Set, Product Code MP-17019-TIP
FDA Device · Class II · 2020-02-19 · Arrow International - FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05400-CA1
FDA Device · Class II · 2020-02-19 · Arrow International - EPIDURAL CATHETERIZATION KIT, Product Code BJC-05400-BEN
FDA Device · Class II · 2020-02-19 · Arrow International - Prometra Programmable 20mL Pump
FDA Device · Class II · 2020-02-19 · Flowonix Medical - Niti-S Esophageal Stent, REF ES1806F, ES1808F, ES1810F, ES1815F, ES2006B, ES2010B, ES1612B, ES1615B, ES1810B, ES1812B, ES1815B, ES1610F, ES…
FDA Device · Class II · 2020-02-19 · Taewoong Medical - FlexTip Plus Epidural Catheterization Kit, Product Code MP-17019-TKP
FDA Device · Class II · 2020-02-19 · Arrow International - Terumo Advanced Perfusion System 1 Roller Pump, 4 Inch, Catalog Number 816570 - Product Usage: is indicated for use for up to 6 hours in th…
FDA Device · Class II · 2020-02-19 · Terumo Cardiovascular Systems - Terumo Advanced Perfusion Assembly Pump Guts, 4 Inch, Catalog Number 801805 - Product Usage: is indicated for use for up to 6 hours in the…
FDA Device · Class II · 2020-02-19 · Terumo Cardiovascular Systems - Medtronic MiniMed 630G System with SmartGuard, Ref/Model # MMT-1515, MMT-1715, MMT-1714, MMT-1754, and MMT-1755 *US and Canada Version Only
FDA Device · Class I · 2020-02-19 · Medtronic - ROSA One 3.1 Brain Application
FDA Device · Class II · 2020-02-19 · Medtech Sas - VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and Philips Allura Xper R9, upgraded to Az…
FDA Device · Class II · 2020-02-19 · Philips North America - Revanesse Versa, PN40081
FDA Device · Class II · 2020-02-19 · Prollenium Medical Technologies - EPIDURAL CATHETERIZATION KIT, Product Code MTO-09903-KU
FDA Device · Class II · 2020-02-19 · Arrow International - Terumo AZUR CX Peripheral Coil System, Detachable 35, CX Coil, REF numbers 45-751019, 45-751324, 45-751632, 45-752039, 45-750407, 45-750511…
FDA Device · Class II · 2020-02-19 · Microvention - FlexTip Plus Epidural Catheterization Set, Product Code JC-05400-B
FDA Device · Class II · 2020-02-19 · Arrow International - HUDSON RCI COMFORT FLO Corrugated Humidification System with Remote Temperature Port, REF 2416, humidifier nebulizer kit
FDA Device · Class I · 2020-02-19 · Teleflex Medical - Medtronic MiniMed 640G Insulin Infusion Pump, Ref#s/Model(s) - MMT-1511, MMT-1711, MMT-1512, MMT-1712, MMT-1751, and MMT-1752 *Not for US D…
FDA Device · Class I · 2020-02-19 · Medtronic - Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System
FDA Device · Class II · 2020-02-19 · Teleflex Medical - Epidural Catheterization Kit with FlexTip Plus, Open Tip, Single- Port Catheter, Product Code ASK-05502-NY
FDA Device · Class II · 2020-02-19 · Arrow International - EPIDURAL CATHETERIZATION KIT, Product Code UR-05501-FR1
FDA Device · Class II · 2020-02-19 · Arrow International - Respironics RP-UI Assy, V60 Ventilators User Interface RP-Kits, REF/P/N: 453561528931, 453561528941, 453561536451, 453561536461
FDA Device · Class II · 2020-02-19 · Respironics California - FlexTip Plus Epidural Catheterization Kit, Product Code CA-02220
FDA Device · Class II · 2020-02-19 · Arrow International - Loop-Style Ultrasound Transducer (Nautilus), 8-foot Cord 5700LAX, that may have been serviced with the following: Pacific Medical GE Corome…
FDA Device · Class II · 2020-02-19 · Pacific Medical Group - FlexTip Plus Epidural Catheterization Set for Pediatric Lumbar Placement, Product Code EC-05520-P
FDA Device · Class II · 2020-02-19 · Arrow International - TheraCath Epidural Catheterization Kit, Product Code ASK-05001-SLR1
FDA Device · Class II · 2020-02-19 · Arrow International - FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code NYU-05500-1
FDA Device · Class II · 2020-02-19 · Arrow International - EPIDURAL CATHETERIZATION KIT, Product Code JC-05400-LB
FDA Device · Class II · 2020-02-19 · Arrow International - ROSA Brain 3.0 Application-Brain
FDA Device · Class II · 2020-02-19 · Medtech Sas - EPIDURAL CATHETERIZATION KIT, Product Code UR-05501-EXP
FDA Device · Class II · 2020-02-19 · Arrow International - Toco+ transducer with ECG/IUP capability (wired), that may have been serviced with the following: Pacific Medical Philips Avalon Smart US/T…
FDA Device · Class II · 2020-02-19 · Pacific Medical Group - EPIDURAL CATHETERIZATION KIT, Product Code BE-05400-DCHH
FDA Device · Class II · 2020-02-19 · Arrow International - 10 cc Luer-Slip Loss of Resistance Syringe, Product Code LR-05501
FDA Device · Class II · 2020-02-19 · Arrow International - FlexTip Plus Epidural Catheterization Kit, Product Code ASK-02220-SRH
FDA Device · Class II · 2020-02-19 · Arrow International - EPIDURAL CATHETERIZATION KIT, Product Code BE-05400B-ETTEL
FDA Device · Class II · 2020-02-19 · Arrow International - Terumo AZUR Peripheral Coil System, Detachable 18, Helical HydroCoil Embolization System, REF numbers 45-481015, 45-481020, 45-481215, 45-4…
FDA Device · Class II · 2020-02-19 · Microvention - FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05503-BID
FDA Device · Class II · 2020-02-19 · Arrow International - Brand Name: Dexcom G6 CGM App for iOS Software Number: SW11677 Software Version: Version 1.4.0 up to corrected Version 1.4.4 GUDID Register…
FDA Device · Class II · 2020-02-19 · Dexcom - Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R
FDA Device · Class II · 2020-02-19 · Implant Direct Sybron Manufacturing - LivaNova Sorin Connect DPIII KOMPL. S5 REF 96-415-130, 2017-08-15, IPX1, RXOnly, (01)04033817901594 Product Usage: The S5 System is used to…
FDA Device · Class III · 2020-02-19 · Livanova Usa - fridababy SmileFrida the TOOTHHUGGER 18+ months Triple Angle Brush Cleans All Sides at Once
FDA Device · Class II · 2020-02-19 · Fridababy - HUDSON RCI COMFORT FLO Corrugated Humidification System, REF 2415, humidifier nebulizer kit
FDA Device · Class I · 2020-02-19 · Teleflex Medical - cobas infinity core, Material No. 7154003001
FDA Device · Class II · 2020-02-19 · Roche Diagnostics Operations - EPIDURAL CATHETERIZATION KIT, Product Code MTO-05500-SU
FDA Device · Class II · 2020-02-19 · Arrow International - Respironics V60 Ventilator, Service # 850008, REF: 1053613, 1053614, 1053617, 1053614
FDA Device · Class II · 2020-02-19 · Respironics California - FlexTip Plus Epidural Catheterization Kit, Product Code YC-02220
FDA Device · Class II · 2020-02-19 · Arrow International - EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-12
FDA Device · Class II · 2020-02-19 · Arrow International - HUDSON RCI COMFORT FLO Humidification System, REF 2410, humidifier nebulizer kit
FDA Device · Class I · 2020-02-19 · Teleflex Medical - HUDSON RCI COMFORT FLO Humidification System With Remote Temperature Port, REF 2414, humidifier nebulizer kit
FDA Device · Class I · 2020-02-19 · Teleflex Medical - The Bard Intra-abdominal Pressure Monitoring Device is composed of a tubing set used for infusing fluid into the urinary bladder through th…
FDA Device · Class II · 2020-02-19 · C R Bard - EPIDURAL CATHETERIZATION KIT, Product Code BE-05400-DCSHO
FDA Device · Class II · 2020-02-19 · Arrow International - External Toco Transducer (M1355A), that may have been serviced with the following: Pacific Medical Philips M1355A Toco Bottom Case, NFPH9315
FDA Device · Class II · 2020-02-19 · Pacific Medical Group - VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1000 Generator Sample Labels 26-0009-9600 Patient s Manual for Depre…
FDA Device · Class II · 2020-02-19 · Livanova Usa - FlexTip Plus Epidural Catheterization Kit, Product Code ASK-17019-MSC
FDA Device · Class II · 2020-02-19 · Arrow International - Respironics V680 Ventilator, Service # 850011, (OUS Only)
FDA Device · Class II · 2020-02-19 · Respironics California - FlexTip Plus Epidural Catheterization Set, Product Code JC-05400-DCS
FDA Device · Class II · 2020-02-19 · Arrow International - EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-04
FDA Device · Class II · 2020-02-19 · Arrow International - Prometra Programmable 20mL Pump
FDA Device · Class II · 2020-02-19 · Flowonix Medical - Button-Style Tocotransducer (Nautilus), 8-foot Cord 2264HAX, that may have been serviced with the following: Pacific Medical GE Corometrics…
FDA Device · Class II · 2020-02-19 · Pacific Medical Group - EPIDURAL CATHETERIZATION KIT, Product Code AT-05501-LIN
FDA Device · Class II · 2020-02-19 · Arrow International - EPIDURAL CATHETERIZATION KIT, Product Code BE-080180-CHH
FDA Device · Class II · 2020-02-19 · Arrow International - Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Single, REF 3910-500-471, UDI 07613327464818, Sterile R, RX Only CE 0197
FDA Device · Class II · 2020-02-19 · Stryker - Medtronic MiniMed 670G System with SmartGuard, Ref #s/Model Number(s) - MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762, MMT-1580, MMT-158…
FDA Device · Class I · 2020-02-19 · Medtronic - EPIDURAL CATHETERIZATION KIT, Product Code ALZANO-05400-B
FDA Device · Class II · 2020-02-19 · Arrow International - Coopervision Vertex Toric /2 Clear Toric- Power +2.25 -0.75/120 Soft (hydrophilic) Contact Lens (extended wear)
FDA Device · Class II · 2020-02-19 · Coopervision - EPIDURAL CATHETERIZATION KIT, Product Code BE-080180-BXL
FDA Device · Class II · 2020-02-19 · Arrow International - SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115
FDA Device · Class II · 2020-02-19 · Depuy Orthopaedics - FlexTip Plus Epidural Catheterization Kit, Product Code AK-05500
FDA Device · Class II · 2020-02-19 · Arrow International - EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-10
FDA Device · Class II · 2020-02-19 · Arrow International - Prometra II 20mL Pump
FDA Device · Class II · 2020-02-19 · Flowonix Medical - Toco M2734A, that may have been serviced with the following: Pacific Medical Philips Avalon Smart US/TOCO Cable Assembly, NFPHA9020
FDA Device · Class II · 2020-02-19 · Pacific Medical Group - PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device intended for the introduction into the body to facilitate the removal of…
FDA Device · Class I · 2020-02-19 · Tytek Medical - Terumo AZUR CX Peripheral Coil System, Detachable 18, CX Coil, REF numbers 45-781032, 45-781238, 45-781434, 45-781639, 45-781836, 45-782040…
FDA Device · Class II · 2020-02-19 · Microvention - Centurion-Surgical trays DYNJ04079Z CIRCUMCISION TRAY STERILE DYNJ08835 DEBRIDEMENT TRAY W/SAFETY SCAL DYNJ1000 NEWBORN CIRCUMCISION TRAY
FDA Device · Class II · 2020-02-12 · Centurion Medical Products - ACCU-CHEK AVIVA ASPAC STRIP 50CT- intended for Blood Glucose Monitoring System Catalog Number: 06453970020
FDA Device · Class II · 2020-02-12 · Roche Diabetes Care - Centurion- Skin Prep Kits SB1280 SKIN SCRUB KIT SB1525 VAGINAL PREP TRAY
FDA Device · Class II · 2020-02-12 · Centurion Medical Products - Reinforced Introducer Sets Maquet 8 Fr., Part Number: 068400040310
FDA Device · Class II · 2020-02-12 · Datascope - Centurion-Skin Prep Tray DYNDP1015 SKIN PREP TRAY
FDA Device · Class II · 2020-02-12 · Centurion Medical Products - AAMI 3 NONREIN SURG GOWN L BNS, Item Code 9515NB
FDA Device · Class II · 2020-02-12 · Cardinal Health - Centurion- Nasal Speculum NSP500ST STERILE NASAL SPECULUM
FDA Device · Class II · 2020-02-12 · Centurion Medical Products - AAMI 3 NONREINF SURGICAL GOWN 3XL, Item Code 9585
FDA Device · Class II · 2020-02-12 · Cardinal Health - Genius 2 Tympanic Thermometer Private Label Item Code: 3069
FDA Device · Class II · 2020-02-12 · Cardinal Health 200 - Roadrunner Hydrophilic PC Wire Guide, Guidewire, Global Product Number G18629, G17866
FDA Device · Class II · 2020-02-12 · Cook - AAMI 3 FABRIC REINF SURG GOWN XL, Item Code 9541
FDA Device · Class II · 2020-02-12 · Cardinal Health - C-Flex Double Pigtail Ureteral Stent Set, Global Product No. G14364 G14365 G14367
FDA Device · Class II · 2020-02-12 · Cook - Y-Type Blood Set, Catalog Number 490425
FDA Device · Class II · 2020-02-12 · B Braun Medical - Vaginal Verification Panel Ref 8208 Lot 8208-11
FDA Device · Class II · 2020-02-12 · Microbiologics - Percutaneous Malecot Nephrostomy Set, Global Product No. G16714 G19107 G19108
FDA Device · Class II · 2020-02-12 · Cook - Dexcom Receiver, REF: MT22719, (Black, Pin, Blue), Rx Only, containing software version SW10617 and revision 4.0.1.048 - Product Usage: A n…
FDA Device · Class II · 2020-02-12 · Dexcom
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)