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.
- MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204984
FDA Device · Class II · 2020-10-28 · Smith And Nephew - 78" (198 cm) APPX 1.7ml, EXT SET, MicroClave Clear, 6-PORT NanoClave MANIFOLD, FILTER .1 unit per pouch, 50 pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - 13 IN(33cm) APPX 1.0 ml, SMALLBORE SET, 4 MicroClave Clear, NanoClave T-Conn, Filter
FDA Device · Class II · 2020-10-28 · Icu Medical - HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL-- Absorbable Suture anchor Product Number: 72203704
FDA Device · Class II · 2020-10-28 · Smith And Nephew - 9.5" (24 cm) Appx 0.56 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Luer Lock
FDA Device · Class II · 2020-10-28 · Icu Medical - 109" (277 cm) Appx 8.6 ml, Transfer Set w/Check Valve, NanoClave T-Connector, Anti-Siphon Valve, 4 Clamps, Smallbore Trifuse Ext Set w/2 Mi…
FDA Device · Class II · 2020-10-28 · Icu Medical - HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK- Absorbable Suture anchor Product Number: 72203707
FDA Device · Class II · 2020-10-28 · Smith And Nephew - TWINFIX ULTRA PLLA HA 4.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202612
FDA Device · Class II · 2020-10-28 · Smith And Nephew - Bien-Air Surgery REF 1600517-001 SN ******* MULTIFUNCTION PEDAL OSSEODUO - Product Usage: Product Usage: intended to convert electrical ene…
FDA Device · Class II · 2020-10-28 · Bien Air Surgery - Synapse PACS Software Version 5.6.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exce…
FDA Device · Class II · 2020-10-28 · Fujifilm Medical Systems U - TWINFIX AB 5.0 SUTR ANCHR W/2 38 DURAB-Absorbable Suture anchors Product Number: 72200785
FDA Device · Class II · 2020-10-28 · Smith And Nephew - 11 IN(28cm)APPX 0.97ml,SMALLBORE SET,NanoClave,6-PORT NanoClave MANIFOLD,BCV.1 unit per pouch, 50 pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - TWINFIX ULTRA 6.5MM PLLA/HA 2 UBWHT/BL-Absorbable Suture anchor Product Number: 72202608
FDA Device · Class II · 2020-10-28 · Smith And Nephew - 7" (18cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave T-Connector, Clamp, Rotating Luer. 1 unit per pouch, 50 multi…
FDA Device · Class II · 2020-10-28 · Icu Medical - 3-Port NanoClave Manifold w/Check Valve, Rotating Luer. 1 unit per pouch, 50 pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - 5" (13 cm) Appx 0.39 ml, Smallbore Bifuse Ext Set w/NanoClave T-Connector, 2 Clamps, Rotating Luer
FDA Device · Class II · 2020-10-28 · Icu Medical - 7" (18 cm) Appx 0.25 ml, Smallbore Ext Set w/Remv NanoClave, Clamp, Luer Lock. 1 unit per pouch, 50 multivac pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - NanoClave Connector. 1 unit per pouch, 100 multivac pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - SkyVision SDS System - Video Integration Model: GC-SDS-BSCB-200 - Product Usage: is a high quality, self-contained video switching and cont…
FDA Device · Class II · 2020-10-21 · Skytron Div The Kmw Group - MediCult Vitrification Cooling Media, Model Number 12284001F
FDA Device · Class II · 2020-10-21 · Coopersurgical - Ezycare Face Mask, Disposable Non Medical Face Masks - Product Usage: marketed under face mask umbrella EUA as source control
FDA Device · Class II · 2020-10-21 · Beyond White Spa D B A Ezywipe - Artis zee or Artis Q systems (listed below) - Product Usage: for single and biplane diagnostic imaging and interventional procedures
FDA Device · Class II · 2020-10-21 · Siemens Medical Solutions Usa - Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophtha…
FDA Device · Class II · 2020-10-21 · Alcon Research - ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine)…
FDA Device · Class II · 2020-10-21 · Siemens Healthcare Diagnostics - Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in h…
FDA Device · Class II · 2020-10-21 · Siemens Healthcare Diagnostics - Percutaneous Neonatal Pigtail Nephrostomy Set, Reference Part Number 080106, Order Number G14508
FDA Device · Class II · 2020-10-21 · Cook - Albumin Gen.2, Catalog 05166861190
FDA Device · Class III · 2020-10-21 · Roche Diagnostics Operations - Aquas PowerFlow Tube Set - Product Usage: The device delivers sterile irrigation fluids to surgical sites during laparoscopic procedures an…
FDA Device · Class II · 2020-10-21 · Genicon - SwiftHook sold as the following: a. Individually as SwiftHook b. Included with Vega505EE mobile lifts Product Usage: The mobile lifts are i…
FDA Device · Class II · 2020-10-21 · Handicare Ab - Servo-i Ventilator, Part No. 6487800, UDI Code 07325710000823 - Product Usage: intended for general and critical ventilator care, and it ca…
FDA Device · Class II · 2020-10-21 · Getinge Group Logistics America - Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper Adapter-Shoulder Prosthesis item: 010000589 - Product Usage: in…
FDA Device · Class II · 2020-10-21 · Biomet - (1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar Cup, E1 Antioxidant Infused, 28 MM, 41 MM: Item No. 110010458
FDA Device · Class II · 2020-10-21 · Biomet - Levo Arm Label: LEVO ARM REF 7887-050 MIZUHO OSI Refurbished Levo Arm Label: LEVO ARM REF 7887-050R MIZUHO OSI - Product Usage: used with M…
FDA Device · Class II · 2020-10-21 · Mizuho Osi - Tina-quant Complement C4 ver.2, Catalog 05991994190
FDA Device · Class III · 2020-10-21 · Roche Diagnostics Operations - GENTIAN Cystatin C Calibrator and Calibrator Kit, for the following models: 1. Gentian C E, Cystatin C Calibrator, 1 x 1 mL, REF 1012, UDI:…
FDA Device · Class II · 2020-10-21 · Gentian As - AquaBplus and AquaBplus B2 Water Purification System
FDA Device · Class II · 2020-10-21 · Fresenius Medical Care Holdings - Pediatric Nephrostomy Stent Set, Reference Part Numbers 080208-S6 and 080208-S7, Order Numbers G15034 and G15035
FDA Device · Class II · 2020-10-21 · Cook - DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel in occlusive peripheral vascu…
FDA Device · Class II · 2020-10-14 · Ra Medical Systems - Kit Model #650600111, MTO Left Heart St Francis Hosp - PG - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of…
FDA Device · Class II · 2020-10-14 · Medline Industries - Kit Model #65220955, MTO Left Heart Kit VA Med San Francisco - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist…
FDA Device · Class II · 2020-10-14 · Medline Industries - BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: EDAT4
FDA Device · Class II · 2020-10-14 · Biomet 3i - Change Healthcare Radiology Solutions 14.0
FDA Device · Class II · 2020-10-14 · Change Healthcare Canada - 1500 Flex Heat and Moisture Exchanger, Catalog Reference 150 - Product Usage: Heat Moisture Exchangers (HM Es) are designed to enhance humi…
FDA Device · Class II · 2020-10-14 · Ab Ulax - Quick Release Gait Belt, 60
FDA Device · Class II · 2020-10-14 · Medline Industries - CERTAIN BELLATEK TITANIUM ABUTMENT 6.0MM Reference Number: IEDAT6
FDA Device · Class II · 2020-10-14 · Biomet 3i - Bard Conquest PTA Balloon dilation Catheter, 6mm x 40mm, 75 cm, Cat
FDA Device · Class II · 2020-10-14 · Bard Peripheral Vascular - Kit Model #65021652, MTO Left Heart Kit United Reg Health - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of…
FDA Device · Class II · 2020-10-14 · Medline Industries - Kit Model #650304917, MTO Protection Station Plus with Drape - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist…
FDA Device · Class II · 2020-10-14 · Medline Industries - Biomet ARTHROSIMPLICITY KIT EU Item Number: 24-4055
FDA Device · Class II · 2020-10-14 · Biomet - Biomet Regenerex Primary Taper Cap Item Number 141269
FDA Device · Class II · 2020-10-14 · Biomet - VERIGENE Processor SP Model No. 10-0000-07
FDA Device · Class II · 2020-10-14 · Luminex - MICROFLEX Diamond Grip Examination Gloves, MF-300 - Product Usage: A patient examination glove is a disposable device intended for medical…
FDA Device · Class II · 2020-10-14 · Ansell Healthcare Products - CERTAIN BELLATEK TIN ABUTMENT 5.0MM Reference Number: IEDAN5
FDA Device · Class II · 2020-10-14 · Biomet 3i - CERTAIN BELLATEK TIN ABUTMENT 4.1MM Reference Number: IEDAN4
FDA Device · Class II · 2020-10-14 · Biomet 3i - Dimension LOCI High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of car…
FDA Device · Class II · 2020-10-14 · Siemens Healthcare Diagnostics - Neoprobe GDS Control Unit, Model Number NPCU3
FDA Device · Class III · 2020-10-14 · Devicor Medical Products - CERTAIN BELLATEK TITANIUM ABUTMENT 5.0MM Reference Number: IEDAT5
FDA Device · Class II · 2020-10-14 · Biomet 3i - Kit Model #650301023, MTO Radiology Kit Cleveland Clinic - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of…
FDA Device · Class II · 2020-10-14 · Medline Industries - Kit Model #65193091, MTO Left Heart Kit - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination o…
FDA Device · Class II · 2020-10-14 · Medline Industries - ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F
FDA Device · Class II · 2020-10-14 · Siemens Medical Solutions Usa - Biomet OnPoint SCOPE PROCEDURE KIT Item Number: 24-3050
FDA Device · Class II · 2020-10-14 · Biomet - BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001
FDA Device · Class II · 2020-10-14 · Roche Diagnostics Operations - VGDF-SKY (R4-010-06) VGA TO FIBER CONVERTER-Single Format Faceplate, a component of the SkyVision Linx 300 Integration Control System Model…
FDA Device · Class II · 2020-10-14 · Skytron Div The Kmw Group - ClearPro Closed Suction Catheter, Model DYNCPDS14T, 14 Fr FOR ENDOTRACHEAL TUBE - Product Usage: Catheters are intended for endotracheal su…
FDA Device · Class II · 2020-10-14 · Medline Industries - Biomet ONPOINT SCOPE PROCEDURE KIT-EU Item Number: 24-3055
FDA Device · Class II · 2020-10-14 · Biomet - DJO EMPOWR Tibial Knee Punch Handle Part No. 801-05-040 and 801-05-018 contained in Instrument Tray for EMPOWR Porous Knee - Product Usage:…
FDA Device · Class II · 2020-10-14 · Encore Medical - Kit Model #650301018, MTO Vascular Surgery - Cleveland Clinic PG - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits con…
FDA Device · Class II · 2020-10-14 · Medline Industries - Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x - Product Usage: intended…
FDA Device · Class II · 2020-10-14 · Brainlab Ag - CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: IEDAT4
FDA Device · Class II · 2020-10-14 · Biomet 3i - Kit Model #650305414, MTO Left Heart with DT Boulder Com Hosp - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consis…
FDA Device · Class II · 2020-10-14 · Medline Industries - PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured, radiopaque, methacrylate based, flowable composite
FDA Device · Class II · 2020-10-14 · Ultradent Products - DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only) Material Number: 05987750001
FDA Device · Class II · 2020-10-14 · Roche Diagnostics Operations - NUVASIVE SPECIALIZED ORTHOPEDICS, INC. Precice Bone Transport Antegrade Femur Trochanter 10 Degree Bend Component of the orthopedic Precice…
FDA Device · Class II · 2020-10-14 · Nuvasive Specialized Orthopedics - BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model Reference Numbers: 3DPMSER, 3DPMSERQ
FDA Device · Class II · 2020-10-14 · Biomet 3i - Dual Mobility Vivacit-E Bearing, Model Number 110031009
FDA Device · Class II · 2020-10-14 · Zimmer Biomet - Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-14 Cutting, Product Number: SV935, UDI: 20884521151755 - Produc…
FDA Device · Class II · 2020-10-07 · Riverpoint Medical - Endo GIA Auto Suture Universal Loading Unit, Item Code 030457 - Product Usage: The Endo GIA universal staplers have applications in abdomin…
FDA Device · Class II · 2020-10-07 · Covidien - ToxCup Drug Screen Cup (AMT Item Number/ AMT Description): HT29A/"ToxCup¿ Drug Screen Cup COC300/MET500/OPI300/THC50/AMP1000/PCP25/OXY100 A…
FDA Device · Class II · 2020-10-07 · Ameditech - Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" PC-10, Product Number: SV835G, UDI: 20884521149721 - Product Usag…
FDA Device · Class II · 2020-10-07 · Riverpoint Medical - Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 36" KV-34, TaperCutting Product Number: CV916, UDI: 20884521153032 -…
FDA Device · Class II · 2020-10-07 · Riverpoint Medical - Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 3.5 mm, Item Code 030455 - Product Usage: The Endo GIA universal staplers…
FDA Device · Class II · 2020-10-07 · Covidien - Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" PC-11 SV487G, UDI: 10884521149595 - Product Usage: indicated for…
FDA Device · Class II · 2020-10-07 · Riverpoint Medical - Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 2/0 Undyed 30" GS-20 CV9975G, UDI: 20884521149585 - Product Usage: indicated for…
FDA Device · Class II · 2020-10-07 · Riverpoint Medical - Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-25, Product Number: CV605, UDI: 20884521152295 - Product Usage:…
FDA Device · Class II · 2020-10-07 · Riverpoint Medical - First Check 4 Panel Drug Cup: COC/MET1000/OPI2000/THC): (THC/COC)
FDA Device · Class II · 2020-10-07 · Ameditech - Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS-21 Taper CV946, UDI: 20884521151298 - Product Usage: indicated f…
FDA Device · Class II · 2020-10-07 · Riverpoint Medical - Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-11, Product Number: SVP2294, UDI: 20884521177403 - Product Usag…
FDA Device · Class II · 2020-10-07 · Riverpoint Medical - Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" CV-25 Taper, Product Number: CV3110, UDI: 20884521150918 - Produc…
FDA Device · Class II · 2020-10-07 · Riverpoint Medical - Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" C-12 Cutting, Product Number: SV2295, UDI: 20884521151397 - Produ…
FDA Device · Class II · 2020-10-07 · Riverpoint Medical - MicroScreen (AMT Item Number/ AMT Description): MSCA-6MBAU/ "MicroScreen AMP300/BZO200/COC300/MET300/OPI300/ THC50 with Cr, Ni, pH, Bl, S.G…
FDA Device · Class II · 2020-10-07 · Ameditech - Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" C-12 Cutting, Product Number: SV2294, UDI 20884521151403 - Produc…
FDA Device · Class II · 2020-10-07 · Riverpoint Medical - Endo GIA Auto Suture Universal Loading Unit 45 mm - 2.5mm, Item Code 030454 - Product Usage: The Endo GIA universal staplers have applicati…
FDA Device · Class II · 2020-10-07 · Covidien - Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code 030450 - Product Usage: The Endo GIA universal stap…
FDA Device · Class II · 2020-10-07 · Covidien - TDDA Drugs of Abuse Cup(AMT Item/ AMT Description): TDDA-6MBAU-CUP /"TDDA Drugs of Abuse Cup AMP300/BZO200/COC300/MET300/OPI300/ THC50 with…
FDA Device · Class II · 2020-10-07 · Ameditech - Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" C-13 Cutting SV2298, UDI: 20884521151021 - Product Usage: indicat…
FDA Device · Class II · 2020-10-07 · Riverpoint Medical - Control, Calibrator Verified, Triage BNP, Model ALR88755
FDA Device · Class II · 2020-10-07 · Medline Industries - MicroTox (AMT Item Number/ AMT Description): MTPA-6MBAU / "MicroTox (AMP300/BZO200)+(COC300/THC50)+ (MET300/MOR300) With Cr, Ni, pH, Bl, S.…
FDA Device · Class II · 2020-10-07 · Ameditech - Consult Diagnostics Drugs Abuse Test Cup (AMT Item Number/ AMT Description): 164-DXA14 /"Consult Diagnostics DRUGS OF ABUSE TEST CUP 14-DRU…
FDA Device · Class II · 2020-10-07 · Ameditech - Olympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope Olympus BF Type Q180 (BF-Q180) All serial numbers - Product Usag…
FDA Device · Class II · 2020-10-07 · Olympus - Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 VL 18" P-10, Product Number: SV32, UDI: 20884521153117 - Product Usage: indi…
FDA Device · Class II · 2020-10-07 · Riverpoint Medical
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)