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.
- HEMO-7 Hemospray Endoscopic Hemostat
FDA Device · Class II · 2020-04-29 · Wilson Cook Medical - TCM4 Base unit, Ref 391-880, UDI:(01)05700693918808, used with the monitor modules TCM4 (902-778), TCM40 (902-778, 902-946 or 902-862), TCM…
FDA Device · Class II · 2020-04-29 · Radiometer Medical Aps - Medivators Endo Smartcap Endoscope Tubing
FDA Device · Class II · 2020-04-29 · Medivators - Contour VL Ureteral Stent Set 6FX22-30CM with .035 Sensor UPN: M006180156080
FDA Device · Class II · 2020-04-29 · Boston Scientific - Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201100880MD - Product Usage: is a 3 lumen silicone catheter with a sensor…
FDA Device · Class II · 2020-04-29 · Degania Medical Devices Pvt - ABL90 FLEX PLUS Analyzer, Model Number 393-092 - Product Usage: It is intended for use in a laboratory environment, near patient or point-o…
FDA Device · Class II · 2020-04-29 · Radiometer Medical Aps - Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101463DO - Product Usage: is a 3 lumen silicone catheter with a sensor…
FDA Device · Class II · 2020-04-29 · Degania Medical Devices Pvt - Medivators Endo Smartcap Endoscope Tubing
FDA Device · Class II · 2020-04-29 · Medivators - Acutus Medical AcQGuide Flex Steerable Introducer with AcQcross QX Integrated Dilator/Transseptal Needle, REF: 122852, SterileEO RxOnly
FDA Device · Class II · 2020-04-29 · Acutus Medical - ABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4MR2 - Product Usage: It is intended for use in a laboratory env…
FDA Device · Class II · 2020-04-29 · Radiometer Medical Aps - Stretch VL Ureteral Stent Set 7FX22-30CM with .035 Sensor UPN: M006185157080
FDA Device · Class II · 2020-04-29 · Boston Scientific - Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, 5.5mm Part Number: 72202902
FDA Device · Class II · 2020-04-29 · Smith And Nephew - Synchron Systems Opiate 2000 ng Reagent (OP2 1 x 250)
FDA Device · Class II · 2020-04-29 · Beckman Coulter - PREVI Isola Insrument and PREVI Isola Printer spares PSUs (power supply units), P1028888-001 PSU (used in Zebra LP2824 Plus printers) PSUs…
FDA Device · Class II · 2020-04-29 · Biomerieux - Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101663MD - Product Usage: is a 3 lumen silicone catheter with a sensor…
FDA Device · Class II · 2020-04-29 · Degania Medical Devices Pvt - ClearCanvas RIS/PACS
FDA Device · Class II · 2020-04-29 · Synaptive Medical - Olympus Pleuravideoscope, Model LTF-160
FDA Device · Class II · 2020-04-29 · Olympus - Stretch VL Ureteral Stent Set 4.8FX22-30CM with .035 Sensor UPN: M006185155080
FDA Device · Class II · 2020-04-29 · Boston Scientific - Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101663DO - Product Usage: is a 3 lumen silicone catheter with a sensor…
FDA Device · Class II · 2020-04-29 · Degania Medical Devices Pvt - RaySert PLUS RSP01
FDA Device · Class II · 2020-04-29 · Rayner Intraocular Lenses - Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Transseptal Needle, REF: 122852, Sterile EO, RxOnly
FDA Device · Class II · 2020-04-29 · Acutus Medical - Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101863DO - Product Usage: is a 3 lumen silicone catheter with a sensor…
FDA Device · Class II · 2020-04-29 · Degania Medical Devices Pvt - Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101863DO - Product Usage: is a 3 lumen silicone catheter with a sensor…
FDA Device · Class II · 2020-04-29 · Degania Medical Devices Pvt - Olympus Pleuravideoscope, Model LTF-240
FDA Device · Class II · 2020-04-29 · Olympus - Stretch VL Ureteral Stent Set 6FX22- 30CM with .035 Sensor UPN: M006185156080
FDA Device · Class II · 2020-04-29 · Boston Scientific - Synaptive ImageDrive Clinical
FDA Device · Class II · 2020-04-29 · Synaptive Medical - Medivators Endo Smartcap Endoscope Tubing
FDA Device · Class II · 2020-04-29 · Medivators - Medivators EndoGator REF 100651
FDA Device · Class II · 2020-04-29 · Medivators - Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 Part Number: 72202901
FDA Device · Class II · 2020-04-29 · Smith And Nephew - Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum
FDA Device · Class II · 2020-04-29 · Csl Behring - Sensor Nitinol Wire with Hydrophilic Tip .038 3CM FLEX STR/150CM UPN: M006670309 1box 5 UPN: M0066703090 single unit
FDA Device · Class II · 2020-04-29 · Boston Scientific - Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101063MD - Product Usage: is a 3 lumen silicone catheter with a sensor…
FDA Device · Class II · 2020-04-29 · Degania Medical Devices Pvt - Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101663DO - Product Usage: is a 3 lumen silicone catheter with a sensor…
FDA Device · Class II · 2020-04-29 · Degania Medical Devices Pvt - Polaris Ultra Ureteral Stent Set 6FX24CM with .035 Sensor UPN: M006192132080
FDA Device · Class II · 2020-04-29 · Boston Scientific - Percuflex Plus Ureteral Stent Set 7FX24CM with .035 Sensor UPN: M006175272080 (edited 1/13/2021)
FDA Device · Class II · 2020-04-29 · Boston Scientific - ARCHITECT HAVAB G Reagent Kit
FDA Device · Class II · 2020-04-29 · Abbott And Kg - Fresenius 2008T Hemodialysis Machine: Part Number Description 190573 2008T HEMODIAL YSIS SYS. OLC/DIASAFE PLUS
FDA Device · Class II · 2020-04-29 · Fresenius Medical Care Holdings - HEMO-10 Hemospray Endoscopic Hemostat
FDA Device · Class II · 2020-04-29 · Wilson Cook Medical - Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX /150CM UPN: M0066703061 box 5 UPN: M0066703060 single unit
FDA Device · Class II · 2020-04-29 · Boston Scientific - Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model Number 110028522 - Product Usage: Intended to be used in surge…
FDA Device · Class II · 2020-04-29 · Biomet - The VITEK 2 Gram-positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in-vitro test to…
FDA Device · Class II · 2020-04-29 · Biomerieux - Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101463MD - Product Usage: is a 3 lumen silicone catheter with a sensor…
FDA Device · Class II · 2020-04-29 · Degania Medical Devices Pvt - Opiate 300 Ng Reagent (OP 1 X 250) for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems OP 300 Urine Calibrators,…
FDA Device · Class II · 2020-04-29 · Beckman Coulter - Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX STR/150CM UPN: M0066703051 box 5 UPN: M0066703050 single unit
FDA Device · Class II · 2020-04-29 · Boston Scientific - ACUVUE OASYS for ASTIGMATISM Brand Contact Lenses
FDA Device · Class II · 2020-04-29 · Johnson And Johnson Vision Care - Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Product #8065751079, Sterile
FDA Device · Class II · 2020-04-29 · Alcon Research - Beckman Coulter Power Express Sample Processing System AU5800XL connection unit, catalog #B36351
FDA Device · Class II · 2020-04-29 · Beckman Coulter - Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101863MD - Product Usage: is a 3 lumen silicone catheter with a sensor…
FDA Device · Class II · 2020-04-29 · Degania Medical Devices Pvt - Canon Aquilion Prime, Model TSX-303A
FDA Device · Class II · 2020-04-22 · Canon Medical System Usa - Nitinol Thermocouple Electrode, 10 cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tiss…
FDA Device · Class II · 2020-04-22 · Boston Scientific Neuromodulation - STA - Deficient VIII, Product Code: 00725
FDA Device · Class II · 2020-04-22 · Diagnostica Stago - Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either the UF-5000 or UD-10 analyzers
FDA Device · Class II · 2020-04-22 · Sysmex America - NavLock Tracker *** Rx Only
FDA Device · Class II · 2020-04-22 · Medtronic Navigation - djosurgical Linear Neck Trials with Spring Sides, Standard, nonsterile, REF S-200635
FDA Device · Class II · 2020-04-22 · Encore Medical - The CF-70 instrument (product code: LXG
FDA Device · Class II · 2020-04-22 · Sysmex America - Canon Aquilion Premium, Model TSX-301B
FDA Device · Class II · 2020-04-22 · Canon Medical System Usa - Canon Aquilion Lightning, Model TSX-036A
FDA Device · Class II · 2020-04-22 · Canon Medical System Usa - Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with software version R001.3.0.0.750505, Rx Only, CE 0197, UDI:…
FDA Device · Class II · 2020-04-22 · Shanghai United Imaging Healthcare - Oncomine Dx Target Test RNA Control- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Cat…
FDA Device · Class II · 2020-04-22 · Life Technologies - Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The MerlinTM Patient Care System (MerlinTM PCS) Model 3650 is a portable, d…
FDA Device · Class II · 2020-04-22 · Abbott - Canon Aquilion One Vision, Model TSX-301C
FDA Device · Class II · 2020-04-22 · Canon Medical System Usa - Nitinol Thermocouple Electrode, 15 cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tiss…
FDA Device · Class II · 2020-04-22 · Boston Scientific Neuromodulation - Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for Gases and Electrolytes
FDA Device · Class II · 2020-04-22 · Smiths Medical Asd - SPICE (JWH-018) CC443
FDA Device · Class II · 2020-04-22 · Carolina Liquid Chemistries - Canon Aquilion One, Model TSX-301A
FDA Device · Class II · 2020-04-22 · Canon Medical System Usa - Nitinol Thermocouple Electrode, 10 cm, 3m Cable - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral…
FDA Device · Class II · 2020-04-22 · Boston Scientific Neuromodulation - Ion Torrent Dx No Template Control Kit- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens C…
FDA Device · Class II · 2020-04-22 · Life Technologies - VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322
FDA Device · Class II · 2020-04-22 · Greiner Bio One North America - Endocuff Vision: models ARV 110, 120, 130, 140 Intended Use: ENDOCUFF VISION is a device attached to the distal end of a colonoscope, desig…
FDA Device · Class II · 2020-04-22 · Boddingtons Plastics - Canon Aquilion Precision, Model TSX-304A
FDA Device · Class II · 2020-04-22 · Canon Medical System Usa - Portex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes
FDA Device · Class II · 2020-04-22 · Smiths Medical Asd - Nitinol Thermocouple Electrode, 15 cm, 3m Cable - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral…
FDA Device · Class II · 2020-04-22 · Boston Scientific Neuromodulation - Nitinol Thermocouple Electrode, 5cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue…
FDA Device · Class II · 2020-04-22 · Boston Scientific Neuromodulation - Canon Aquilion One, Model TSX-305A/3 V8.3 with FIRST 2.1
FDA Device · Class II · 2020-04-22 · Canon Medical System Usa - Oncomine Dx Target Test RNA/DNA Panel- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, C…
FDA Device · Class II · 2020-04-22 · Life Technologies - Wallace Artificial Insemination Catheter, 180 mm, Sterile, Quantity: 1 Box (10 units), Model: AIC18JP, Cooper Surgical Inc., (01) 2 0888937…
FDA Device · Class III · 2020-04-22 · Coopersurgical - Oncomine Dx Target Test DNA Control-IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Cata…
FDA Device · Class II · 2020-04-22 · Life Technologies - ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Patient Preoperative Skin Preparation, Non-s…
FDA Device · Class II · 2020-04-22 · Merit Medical Systems - Canon Aquilion Prime SP, Model TSX-303B
FDA Device · Class II · 2020-04-22 · Canon Medical System Usa - BIOMET StageOne, Shoulder Cement Spacer Mold 14 MM, 58 X 24 X 64 MM, Silicone, Sterile, Item 431414
FDA Device · Class II · 2020-04-15 · Biomet - ONCOR Avante Garde #5863472, ONCOR Expression #7360717, ONCOR Impression #5857920, ONCOR Impression Plus #5857912 with Digital LINAC System…
FDA Device · Class II · 2020-04-15 · Siemens Medical Solutions Usa - BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 200 MM, Silicone, Sterile, Item 431199
FDA Device · Class II · 2020-04-15 · Biomet - BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160
FDA Device · Class II · 2020-04-15 · Biomet - BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 200 MM, Silicone, Sterile, Item 431196
FDA Device · Class II · 2020-04-15 · Biomet - BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165
FDA Device · Class II · 2020-04-15 · Biomet - Thermage Face Tip 3.0, REF/UDI: TTNS3,00C3-400/UDI (01)000850608002377
FDA Device · Class II · 2020-04-15 · Solta Medical - BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 165 MM, Silicone, Sterile, Item 431194
FDA Device · Class II · 2020-04-15 · Biomet - GEM Microvascular Anastomotic Coupler Devices - Product Usage: is intended to be used in the anastomosis of veins and arteries normally enc…
FDA Device · Class II · 2020-04-15 · Baxter Healthcare - The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitative Measurement of SHBG is a chemiluminescent immunoassay intended…
FDA Device · Class II · 2020-04-15 · Qualigen - BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170
FDA Device · Class II · 2020-04-15 · Biomet - BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181
FDA Device · Class II · 2020-04-15 · Biomet - BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM, Silicone, Sterile, Item 431192
FDA Device · Class II · 2020-04-15 · Biomet - BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 17 X 165 MM, 64 MM, Silicone, Sterile, Item 431217
FDA Device · Class II · 2020-04-15 · Biomet - aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00
FDA Device · Class II · 2020-04-15 · Aap Implantate Ag - ARCHITECT C System Mixer - Product Usage: The ARCHITECT Clinical Chemistry System is designed to perform automated chemistry tests, utilizi…
FDA Device · Class II · 2020-04-15 · Abbott Laboratories - ABL800 FLEX, model number/UDI 393-800/0570 In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, c…
FDA Device · Class II · 2020-04-15 · Radiometer Medical Aps - BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile, Item 431184
FDA Device · Class II · 2020-04-15 · Biomet - BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, Item 431410
FDA Device · Class II · 2020-04-15 · Biomet - BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180
FDA Device · Class II · 2020-04-15 · Biomet - GEM Microvascular Anastomotic Coupler Devices - Product Usage: s intended to be used in the anastomosis of veins and arteries normally enco…
FDA Device · Class II · 2020-04-15 · Baxter Healthcare
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