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.
- ARTISTE MV System Model #8139789 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
FDA Device · Class II · 2020-04-15 · Siemens Medical Solutions Usa - KWIK-STIK 2 Pack Trichosporon dermatis derived from ATCC 204094 (Catalog# 0778P, lot 778-65-3)
FDA Device · Class II · 2020-04-15 · Microbiologics - MEVATRON M2/Primus Mid-Energy Model #01940035, MEVATRON PRIMART #05500371, MEVATRON KD-2 #08515520, MEVATRON KD2 #01940753, MEVATRON M-2 67…
FDA Device · Class II · 2020-04-15 · Siemens Medical Solutions Usa - BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170
FDA Device · Class II · 2020-04-15 · Biomet - BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190
FDA Device · Class II · 2020-04-15 · Biomet - BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 155 MM, Silicone, Sterile, Item 431193
FDA Device · Class II · 2020-04-15 · Biomet - Jamshidi Bone Marrow Biopsy/Aspiration Needle, with Luer Lock Adapter 11GX4 ASP, Sterile - Product Code: DJ4011X - Product Usage: The devic…
FDA Device · Class II · 2020-04-15 · Bard Peripheral Vascular - BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile, Item 431412
FDA Device · Class II · 2020-04-15 · Biomet - BIOMET StageOne Hip Cement Spacer Mold with Insert, 52 MM, Silicone, Sterile, Item 431182
FDA Device · Class II · 2020-04-15 · Biomet - LabPro Data Management System, UDI: 15099590676872 - Product Usage: The LabPro Data Management System is a Microsoft Windows based software…
FDA Device · Class II · 2020-04-15 · Beckman Coulter - BIOMET Custom StageOne Hip Femoral Reinforcement, 9 X 125 MM, Stainless Steel, PMI Instrument, Sterile, Item CP161972
FDA Device · Class II · 2020-04-15 · Biomet - BIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile, Item 431185
FDA Device · Class II · 2020-04-15 · Biomet - BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 13 X 145 MM, 57 MM, Silicone, Sterile, Item 431213
FDA Device · Class II · 2020-04-15 · Biomet - BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 43 MM, Silicone, Sterile, Item 431207
FDA Device · Class II · 2020-04-15 · Biomet - GEM Microvascular Anastomotic Coupler Devices s intended to be used in the anastomosis of veins and arteries normally encountered in micros…
FDA Device · Class II · 2020-04-15 · Baxter Healthcare - BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406
FDA Device · Class II · 2020-04-15 · Biomet - Firefly Floorsitter, Firefly Splashy Bathseat, Firefly GoTo Seat - Product Usage: The Splashy Bath-Seat is a Portable bath seat for childre…
FDA Device · Class II · 2020-04-15 · James Leckey Design - BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile, Item 431183
FDA Device · Class II · 2020-04-15 · Biomet - BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175
FDA Device · Class II · 2020-04-15 · Biomet - Beckman Coulter MicroScan PROMPT Inoculation System-D, Catalog Number B1026-10D, UDI: 15099590659561 - Product Usage: The Prompt Inoculatio…
FDA Device · Class II · 2020-04-15 · Beckman Coulter - BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile, Item 431408
FDA Device · Class II · 2020-04-15 · Biomet - ZIMMER Oscillating Saw Blade -Cutting 75mm x 19mm x 1.00/1.27mm.intended for bone or cartilage in orthopedic procedures
FDA Device · Class II · 2020-04-15 · Synvasive Technology - BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 200 MM, Silicone, Sterile, Item 431198
FDA Device · Class II · 2020-04-15 · Biomet - "HEMOGLOBIN A1c CALIBRATORS *** REF 4P52-01 *** 307261/R03 *** S4P5X0 *** FOR USE WITH ARCHITECT" - Product Usage: use in the calibration o…
FDA Device · Class II · 2020-04-15 · Abbott Laboratories - BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165
FDA Device · Class II · 2020-04-15 · Biomet - BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 51 MM, Silicone, Sterile, Item 431209
FDA Device · Class II · 2020-04-15 · Biomet - BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM, Silicone, Sterile, Item 431191
FDA Device · Class II · 2020-04-15 · Biomet - BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 200 MM, Silicone, Sterile, Item 431197
FDA Device · Class II · 2020-04-15 · Biomet - Microbiologics QC SETS AND PANELS, YST Comprehensive QC Set, REF 5195P, containing Trichosporon dermatis, ATCC 204094, QR Code: (01)7084535…
FDA Device · Class II · 2020-04-15 · Microbiologics - PRIMUS HI #04504200 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
FDA Device · Class II · 2020-04-15 · Siemens Medical Solutions Usa - McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management
FDA Device · Class II · 2020-04-15 · Change Healthcare Canada - BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 200 MM, Silicone, Sterile, Item 431195
FDA Device · Class II · 2020-04-15 · Biomet - BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175
FDA Device · Class II · 2020-04-15 · Biomet - Component for Laser Scanning Microscopes (LSM 700, LSM 800 and LSM 900)
FDA Device · Class II · 2020-04-15 · Zeiss Carl - Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper Adapter-indicated for primary, fracture, or revision total shou…
FDA Device · Class II · 2020-04-08 · Biomet - Merits E604 Pilot Navigator Stairlift - Product Usage: To transport patients up stairs
FDA Device · Class II · 2020-04-08 · Merits Holdings - AmniSure ROM Test, Material Nos
FDA Device · Class II · 2020-04-08 · Qiagen Sciences - Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Gridlock Ankle Plating System, Model 320-0…
FDA Device · Class II · 2020-04-08 · Trilliant Surgical - Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Ltd Tiger Large Cannulated Screw System,…
FDA Device · Class II · 2020-04-08 · Trilliant Surgical - Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Small Joint Reaming System, Model 311-00-0…
FDA Device · Class II · 2020-04-08 · Trilliant Surgical - 8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel, Sterile: R, PX only, UDI: (01)00812926022345(17)231225 (10)TSL007202
FDA Device · Class II · 2020-04-08 · Trilliant Surgical - Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039
FDA Device · Class II · 2020-04-08 · Maquet Cardiovascular Us Sales - Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Two-Step Hammertoe Implant System, Model 2…
FDA Device · Class II · 2020-04-08 · Trilliant Surgical - Philips V60 Ventilators with Power Management PCBA part number 1055906
FDA Device · Class II · 2020-04-08 · Respironics California - Stryker Neurovascular, AXS Vecta 74 Aspiration Catheter, Ref
FDA Device · Class II · 2020-04-08 · Stryker Neurovascular - Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Ltd Tiger Headless Cannulated Screw Syste…
FDA Device · Class II · 2020-04-08 · Trilliant Surgical - Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Gridlock Plating System, Model 310-01-100
FDA Device · Class II · 2020-04-08 · Trilliant Surgical - Gentell Hydrogel Ag 4oz
FDA Device · Class II · 2020-04-08 · Gentell - DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138 - Product Usage: patient restraint
FDA Device · Class II · 2020-04-08 · Deroyal Industries - natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph
FDA Device · Class II · 2020-04-08 · Natus Neurology - Instructions for Use and Surgical Cleaning Sterilization Protocol for Trilliant Surgical Ltd Twist Sublatar Implant System, Model 112-00-001
FDA Device · Class II · 2020-04-08 · Trilliant Surgical - Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd 3S Hemi Toe Implant System, Model 111-00-0…
FDA Device · Class II · 2020-04-08 · Trilliant Surgical - Expression MR400 MRI Patient Monitoring System Model Number: 866185 Software version number: 01.03.00, 01.04.00, 01.05.00, and 01.07.00 - P…
FDA Device · Class II · 2020-04-08 · Philips North America - LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88
FDA Device · Class I · 2020-04-08 · Lemaitre Vascular - NAVIO Soft Tissue Protector, included in instrument kits
FDA Device · Class II · 2020-04-08 · Smith And Nephew - Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Disco Subtalar Implant System, Model 112-0…
FDA Device · Class II · 2020-04-08 · Trilliant Surgical - Butterfly iQ Ultrasound System containing the Auto EF(Ejection Fraction) Tool REF/Model: 850-20003 UDI: (01)00866646000206 Software version…
FDA Device · Class II · 2020-04-08 · Butterfly Network - iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS IPOLY IMPLANT KIT LEFT) Product Usage: The iTotal CR Knee Repl…
FDA Device · Class II · 2020-04-08 · Conformis - TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0, 3.0.0, 4.0.0, 4.1.0 and 4.1.1. Intended: For in vitro coagulatio…
FDA Device · Class II · 2020-04-08 · Haemonetics - Gentell Hydrogel Ag 4x8, model no
FDA Device · Class II · 2020-04-08 · Gentell - Gentell Hydrogel Ag 4x4, model no
FDA Device · Class II · 2020-04-08 · Gentell - LifePAK 500 Automated External Defibrillator, model numbers: 3005400-XXX, U3005400-XXX, 3011790-XXX/, U3011790-XXX - Product Usage: The LIF…
FDA Device · Class II · 2020-04-08 · Physio Control - Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Volume Tool is a segmentation measurement tool REF/Model: 850-2000…
FDA Device · Class II · 2020-04-08 · Butterfly Network - Gentell Hydrogel Ag 2x2, model no GEN-11220 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gau…
FDA Device · Class II · 2020-04-08 · Gentell - BD WAVELINQ 4F EndoAVF System, Arterial Catheter 50 cm, Venous Catheter 43 cm, Sterile EO, Rx only, Mfr
FDA Device · Class II · 2020-04-08 · Bard Peripheral Vascular - Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Tiger Cannulated Screw System, Model 210-…
FDA Device · Class II · 2020-04-08 · Trilliant Surgical - Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403xx series, which includes: 8403AX, AXC, BX,…
FDA Device · Class II · 2020-04-08 · Karl Storz Endoscopy - C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)05051700018456
FDA Device · Class II · 2020-04-08 · The Binding Site Group - iTotal CR Knee Replacement System, Model No. TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT) - Product Usage: The iTotal CR Knee…
FDA Device · Class II · 2020-04-08 · Conformis - Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000
FDA Device · Class II · 2020-04-08 · Stryker Communications - Pharos Excimer Laser, Model: EX-308 - Product Usage: The Pharos EX-308 Excimer Laser System is designed to treat the skin disorders psorias…
FDA Device · Class II · 2020-04-08 · Ra Medical Systems - Stryker Neurovascular, AXS Vecta 71 Aspiration Catheter, Ref
FDA Device · Class II · 2020-04-08 · Stryker Neurovascular - Medline Winged Sponges Presaturated W/PVP REF DYND70289 DYND70289H Expiration 06/30/2022
FDA Device · Class II · 2020-04-01 · Medline Industries - PediaPrep Tubes (MD0033-T) and Single use cups (MD0033-SUP)
FDA Device · Class II · 2020-04-01 · Carroll Baccari - LN 3R70-01
FDA Device · Class II · 2020-04-01 · Abbott And Kg - 1. Vaccess CT Power-Injectable Implantable Port with Suture Plugs, Ref: 7496000, UDI:(01)00801741027482 Product Usage: Bard implantable por…
FDA Device · Class II · 2020-04-01 · Bard Peripheral Vascular - Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen Bracket, single monitor mount, 27" max. screen size Part number 3FCM1
FDA Device · Class II · 2020-04-01 · Skytron Div The Kmw Group - Imager II 5F Angiographic Catheters, 5 units per package
FDA Device · Class I · 2020-04-01 · Boston Scientific - RayStation standalone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 7.0, 8.0, 8.1, 9.0, 9.1 - Product Usa…
FDA Device · Class II · 2020-04-01 · Raysearch Laboratories Ab - VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators
FDA Device · Class II · 2020-04-01 · Livanova Usa - Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm
FDA Device · Class II · 2020-04-01 · Medtronic Ats Medical - Omnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239 M/D: PDM-USA1-D001-MG-USA1 EU: PT-000010 - M/D: INT1-D001-MG PT-000…
FDA Device · Class II · 2020-04-01 · Insulet - Karl Storz NEURO-FIBERSCOPE, Model # 11282BN1, Flexible Pediatric Neuroscope
FDA Device · Class II · 2020-04-01 · Karl Storz Endoscopy - Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
FDA Device · Class II · 2020-04-01 · Medtronic Minimed - MVAP MEDICAL SUPPLIES INC, Mavidon CardioPrep Single, 24 use cups, Re order # MCP-24
FDA Device · Class II · 2020-04-01 · Carroll Baccari - 1. PowerPort M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter with Suture Plugs, REF: 1809600, UDI: (0…
FDA Device · Class II · 2020-04-01 · Bard Peripheral Vascular - MiniMed Paradigm Model 511 Insulin Pump
FDA Device · Class II · 2020-04-01 · Medtronic Minimed - Dimension Vista¿ Total Bilirubin Flex¿ reagent cartridge -In vitro Diagnostic for the determination of total bilirubin
FDA Device · Class II · 2020-04-01 · Siemens Healthcare Diagnostics - Spectrum Central Venous Catheter Tray, Irrigation Catheter, Reference Part Number C-UDLMY-401 J-ABRM-HC-IHl-FST, Order Number G48053
FDA Device · Class II · 2020-04-01 · Cook - 1. Power Port isp M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter with Suture Plugs, Ref: 1809660, UD…
FDA Device · Class II · 2020-04-01 · Bard Peripheral Vascular - MiniMed Paradigm Insulin pump, model number MMT-712
FDA Device · Class II · 2020-04-01 · Medtronic Minimed - Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
FDA Device · Class II · 2020-04-01 · Medtronic Minimed - Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medi…
FDA Device · Class II · 2020-04-01 · Capintec - MiniMed Paradigm 512 Insulin pump
FDA Device · Class II · 2020-04-01 · Medtronic Minimed - Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
FDA Device · Class II · 2020-04-01 · Medtronic Minimed - Medtronic MiniMed Paradigm Veo Insulin pump, model numbers MMT-554 and MMT-754
FDA Device · Class II · 2020-04-01 · Medtronic Minimed - Medtronic MiniMed Paradigm Insulin pump, model numbers MMT 515 and MMT-715
FDA Device · Class II · 2020-04-01 · Medtronic Minimed - Honeywell Pressure Transducer- Part Number: 370506-22
FDA Device · Class II · 2020-04-01 · Fresenius Medical Care Holdings - Optium EZ Blood Glucose Monitoring System, UDI: 00093815710653
FDA Device · Class II · 2020-04-01 · Abbott Diabetes Care - Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
FDA Device · Class II · 2020-04-01 · Medtronic Minimed
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)