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.

• Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190
  FDA Device · Class II · 2020-09-23 · Roche Diagnostics Operations
• WallFlexTM Biliary RX Fully Covered Stent System RMV (10mmx60mm Stent) UPN: M00570370 - Product Usage: is indicated for use in the palliati…
  FDA Device · Class II · 2020-09-23 · Boston Scientific
• The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer mobile device
  FDA Device · Class II · 2020-09-23 · Medtronic
• Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x3/32, Catalog Number 5791 - Product Usage: intended for use with Terumo and Sa…
  FDA Device · Class II · 2020-09-23 · Terumo Cardiovascular Systems
• 13 ft Handpiece Cable, component of the Dermatome Sets Model S and Model S6 and also as a spare part - Product Usage: are intended for use…
  FDA Device · Class II · 2020-09-23 · Integra Lifesciences
• Model No:T-SPOT.TB8, Catalogue No.: TB.300
  FDA Device · Class III · 2020-09-23 · Oxford Immunotec
• Lactate Dehydrognease P-L, (UV), Catalog Number LD3818 - Product Usage: device intended for the quantitative in vitro determination of Lact…
  FDA Device · Class II · 2020-09-23 · Randox Laboratories
• The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v2.0 or v2.2 (used with the QuantStudio Real-Time P…
  FDA Device · Class II · 2020-09-23 · Life Technologies
• AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
  FDA Device · Class II · 2020-09-23 · Randox Laboratories
• Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagnostic for BHCG-pregnancy Part number: 020661 The AIA-Pack BH…
  FDA Device · Class II · 2020-09-23 · Tosoh Bioscience
• Integra Padgett Dermatome Set - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn tr…
  FDA Device · Class II · 2020-09-23 · Integra Lifesciences
• Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm Reference part Number: UFH-526 - Product Usage: Used for temporary internal drain…
  FDA Device · Class II · 2020-09-23 · Cook
• Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial…
  FDA Device · Class II · 2020-09-23 · Siemens Healthcare Diagnostics
• AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
  FDA Device · Class II · 2020-09-23 · Randox Laboratories
• The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v1.2 for 7500 RTPCR instruments, includes the assay…
  FDA Device · Class II · 2020-09-23 · Life Technologies
• Aptio Automation systems with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10
  FDA Device · Class II · 2020-09-23 · Inpeco
• NovaPACS Diagnostic Viewer
  FDA Device · Class II · 2020-09-23 · Novarad
• Integra Padgett Electric Dermatome Set - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/o…
  FDA Device · Class II · 2020-09-23 · Integra Lifesciences
• Model No:T-SPOT.TB50, Catalogue No.: TB.50
  FDA Device · Class III · 2020-09-23 · Oxford Immunotec
• Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842 - Product Usage: device intended for the quantitative in vitro determination…
  FDA Device · Class II · 2020-09-23 · Randox Laboratories
• Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (RE…
  FDA Device · Class II · 2020-09-23 · Imactis
• Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only
  FDA Device · Class II · 2020-09-23 · Cook
• Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32, Catalog Number 5773 - Product Usage: intended for use with Terumo and Sa…
  FDA Device · Class II · 2020-09-23 · Terumo Cardiovascular Systems
• Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) - Product Usage: Instructions for Use - Centrifugal Pump System is a device that…
  FDA Device · Class III · 2020-09-23 · Maquet Cardiovascular Us Sales
• PrimeStore Molecular Transport Medium (PS-MTM), Model Numbers LH-1-2, LH-1-3, LH-1-4, LH-1-5, LH-1-5CC, LH-1-15CC - Product Usage: intended…
  FDA Device · Class II · 2020-09-23 · Longhorn Vaccines And Diagnostic
• BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assembly Replacement Kits (P/N 49000239, 49000346, 49000438, 4900043…
  FDA Device · Class I · 2020-09-16 · Carefusion 303
• Talladium Luminesse Zirconia Discs, Zirconia HT Disc 98x20mm A1, Shaded Zirconia Blend 2.0 50# A1, Model No. 5147-A1;(UDI): D7915147A10 - P…
  FDA Device · Class II · 2020-09-16 · Talladium
• SINGLES Carbide US-No. FG556
  FDA Device · Class II · 2020-09-16 · Hager And Meisinger
• QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA) - Product Usage: intended for the qualitative detection and diffe…
  FDA Device · Class II · 2020-09-16 · Qiagen Sciences
• PC Unit Front Case with Keypad Replacement Kits: TC10008389 ASSY CASE FRONT W/KEYPAD 8015LS, TC10010217 ASSY FRT CASE W/ KEYPAD 8015 M2, TC…
  FDA Device · Class I · 2020-09-16 · Carefusion 303
• Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845
  FDA Device · Class II · 2020-09-16 · Intuitive Surgical
• BD Alaris System
  FDA Device · Class I · 2020-09-16 · Carefusion 303
• SICAT IMPLANT V2.0
  FDA Device · Class II · 2020-09-16 · Sicat And Kg
• Merge PACS
  FDA Device · Class II · 2020-09-16 · Merge Healthcare
• ION Reprocessing Accessories Kit, IF1000 (Part Number: 490024-03) UDI:00886874119129
  FDA Device · Class II · 2020-09-16 · Intuitive Surgical
• PROFEMUR Titanium and Cobalt Chrome modular necks, Item Numbers and descriptions: Item Number Description Description 2 PHAC1202 PROFEMUR N…
  FDA Device · Class II · 2020-09-16 · Microport Orthopedics
• Medcomp 15.SF X 24CM Titan HD CATHETER (CUFF 19CM FROM TIP) Ref: THD155024
  FDA Device · Class II · 2020-09-16 · Medical Components
• Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a tracheotomized patient for up…
  FDA Device · Class II · 2020-09-16 · Smiths Medical Asd
• EVOS Screws - Product Usage: is a part of the EVOS MINI plating system, indicated for fracture fixation, arthrodesis, reconstruction, repla…
  FDA Device · Class II · 2020-09-16 · Smith And Nephew
• Alaris System PC Unit Model 8015
  FDA Device · Class I · 2020-09-16 · Carefusion 303
• The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm
  FDA Device · Class II · 2020-09-09 · Exactech
• StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-TRL-AO US - Product Usage: is used for peripheral neural stimulation to provide t…
  FDA Device · Class II · 2020-09-09 · Stimwave Technologies
• StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - Product Usage: is used for peripheral neural…
  FDA Device · Class II · 2020-09-09 · Stimwave Technologies
• Dimension Vista High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of ca…
  FDA Device · Class II · 2020-09-09 · Siemens Healthcare Diagnostics
• PROTEXIS Latex Micro Surgical Gloves Size 6.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or…
  FDA Device · Class II · 2020-09-09 · Cardinal Health 200
• Parvovirus B19 IgG EIA kit Part No. V519IGUS
  FDA Device · Class II · 2020-09-09 · Diasorin
• Pancreatic Amylase AY3855 batch 480483 Pancreatic Amylase Ethylidene Blocked-pNPG7 Reagent
  FDA Device · Class II · 2020-09-09 · Randox Laboratories
• Symbia S-Series and Symbia T-Series - Product Usage: Intended use of the device SPECT: To detect or image the distribution of radionuclides…
  FDA Device · Class II · 2020-09-09 · Siemens Medical Solutions Usa
• BD Alaris System
  FDA Device · Class II · 2020-09-09 · Carefusion 303
• StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-RCV-AO US and 2. FR4A-RCV-A0 EU - Product Usage: is used for peripheral neur…
  FDA Device · Class II · 2020-09-09 · Stimwave Technologies
• PROTEXIS Latex Micro Surgical Gloves Size 7.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or…
  FDA Device · Class II · 2020-09-09 · Cardinal Health 200
• Pleur-evac Thoracic Catheters Catalog No: DTRC-20S The thoracic catheter is indicated to be used in any surgical procedure requiring attach…
  FDA Device · Class II · 2020-09-09 · Teleflex Medical
• PROTEXIS Latex Micro Surgical Gloves Size 8.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or…
  FDA Device · Class II · 2020-09-09 · Cardinal Health 200
• Thermo Scientific Remel Bordetella pertussis Agglutinating Serum Product Number: R30165501, UDI-DI: 05056080501826 - Product Usage: Bordete…
  FDA Device · Class II · 2020-09-09 · Remel Europe
• Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative tool supporting hemodynamic c…
  FDA Device · Class II · 2020-09-09 · Siemens Medical Solutions Usa
• StimQ Peripheral Nerve Stimulator System (PNS) Models FR4A-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide…
  FDA Device · Class II · 2020-09-09 · Stimwave Technologies
• PROTEXIS Latex Micro Surgical Gloves Size 7.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or…
  FDA Device · Class II · 2020-09-09 · Cardinal Health 200
• StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-TRL-BO US and 2. FR4A-TR-BO - Product Usage: is used for peripheral neural s…
  FDA Device · Class II · 2020-09-09 · Stimwave Technologies
• Plastic Cannula HOLDEX Item # 450216 - Product Usage: - Product Usage: It is intended for use in routine specimen withdrawal from specimen…
  FDA Device · Class II · 2020-09-09 · C A Greiner And Sohne Gesellschaftmbh
• Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent
  FDA Device · Class II · 2020-09-09 · Randox Laboratories
• PROTEXIS Latex Micro Surgical Gloves Size 8.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or…
  FDA Device · Class II · 2020-09-09 · Cardinal Health 200
• The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional p…
  FDA Device · Class II · 2020-09-09 · Ge Healthcare
• StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide t…
  FDA Device · Class II · 2020-09-09 · Stimwave Technologies
• PROTEXIS Latex Micro Surgical Gloves Size 6.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or…
  FDA Device · Class II · 2020-09-09 · Cardinal Health 200
• PROTEXIS Latex Micro Surgical Gloves Size 5.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or…
  FDA Device · Class II · 2020-09-09 · Cardinal Health 200
• Cirq Arm System - Model SBS 1.3.2 (Art.No. 56000-01B) and SBS 1.4 (Art.No. 56000-01C) of the CIRQ Arm System (56000 and 56000A)
  FDA Device · Class II · 2020-09-09 · Brainlab Ag
• PROTEXIS Latex Micro Surgical Gloves Size 9.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or…
  FDA Device · Class II · 2020-09-09 · Cardinal Health 200
• Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 34cc IAB Kit, P/N: 0684-00-0469-01, 0684-00-0469-01C, 0684-00-0469-01U, 0684-0…
  FDA Device · Class II · 2020-09-02 · Datascope
• ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 8¿
  FDA Device · Class II · 2020-09-02 · Globus Medical
• ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 8¿
  FDA Device · Class II · 2020-09-02 · Globus Medical
• ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿
  FDA Device · Class II · 2020-09-02 · Globus Medical
• Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coated Micro-Plate
  FDA Device · Class III · 2020-09-02 · Orasure Technologies
• Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0608 - Product Usage: Indications For…
  FDA Device · Class II · 2020-09-02 · Datascope
• Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 25cc IAB Kit P/N: 0684-00-0478-01, 0684-00-0478-01C, 0684-00-0478-01U 0684-00-0…
  FDA Device · Class II · 2020-09-02 · Datascope
• ALTERA Spacer ALTERA Spacer, 10x26, 8-12mm, 8¿
  FDA Device · Class II · 2020-09-02 · Globus Medical
• Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0607 - Product Usage: Indications For…
  FDA Device · Class II · 2020-09-02 · Datascope
• Flexible Intubation Fiberscope, Part: 11302BD2, with Instruction Manual: Z18445US - Product Usage: are intended to be used for examination…
  FDA Device · Class II · 2020-09-02 · Karl Storz Endoscopy
• VITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS In vitro Diagnostic quantitatively measure total bilirubin (TBIL) concentration in s…
  FDA Device · Class II · 2020-09-02 · Ortho Clinical Diagnostics
• ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 15¿
  FDA Device · Class II · 2020-09-02 · Globus Medical
• Flexible Intubation Video Endoscope, Part: 11303BNX, with Instruction Manual: Z20827US - Product Usage: are intended to be used for examina…
  FDA Device · Class II · 2020-09-02 · Karl Storz Endoscopy
• Cobra x5 1-CH EMG ET Tube, 6.0mm, REF: LTE700S-5, Rx Only, Sterile EO UDI: B006:TE700S52$$7050918B - Product Usage: For continuous EMG moni…
  FDA Device · Class II · 2020-09-02 · Neurovision Medical Products
• Flexible DCI Intubation Fiberscope, Part: 11302BDD2, with Instruction Manual: Z18445US - Product Usage: are intended to be used for examina…
  FDA Device · Class II · 2020-09-02 · Karl Storz Endoscopy
• ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 8¿
  FDA Device · Class II · 2020-09-02 · Globus Medical
• VITROS XT3400 Chemistry System, Product code 6844458
  FDA Device · Class II · 2020-09-02 · Ortho Clinical Diagnostics
• Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan) - Product Usage: Indications For Use: Acute Coronary Syndrome…
  FDA Device · Class II · 2020-09-02 · Datascope
• CARTO 3 System (Software Version V7.1.80), CARTO VISITAG Module - Product Usage: FGThe intended use of the system is catheter-based cardiac…
  FDA Device · Class II · 2020-09-02 · Biosense Webster Israel
• Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMT ET Tube, 7.0mm REF: NVTKIT-C7-5, RxOnly, Sterile, UDI: B006NvtKITc752/$$7062818C - Produ…
  FDA Device · Class II · 2020-09-02 · Neurovision Medical Products
• ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 8¿
  FDA Device · Class II · 2020-09-02 · Globus Medical
• Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 7.5 Fr 40cc IAB Kit P/N: 0684-00-0568-01, 0684-00-0568-01U, 0684-00-0568-05,…
  FDA Device · Class II · 2020-09-02 · Datascope
• Cobra x5 1-Ch EMG ET Tube, 7.0mm, REF LTE700M-5, Rx Only, Sterile EO CE UDI: B006LTE700M52/$$7061418C - Product Usage: For continuous EMG m…
  FDA Device · Class II · 2020-09-02 · Neurovision Medical Products
• ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 15¿
  FDA Device · Class II · 2020-09-02 · Globus Medical
• Cobra x5 2-Ch EMG ET Tube, 8.0mm, REF: LTE700DCL-5, Rx Only, Sterile EO UDI: B006LTE700DCL52 - Product Usage: For continuous EMG monitoring…
  FDA Device · Class II · 2020-09-02 · Neurovision Medical Products
• Datascope Intra-Aortic Balloon Catheters (IABs)-MEGA 7.5Fr 40cc IAB Kit P/N: 0684-00-0295-01, 0684-00-0295-01U, 0684-00-0295-02, 0684-00-02…
  FDA Device · Class II · 2020-09-02 · Datascope
• Cobra x5 2-Ch EMG ET Tube, 6.0mm, REF: LTE700DCS-5, Rx Only, Sterile EO UDI: B006LTE700DCS52/$$7062618C - Product Usage: For continuous EMG…
  FDA Device · Class II · 2020-09-02 · Neurovision Medical Products
• Flexible Intubation Video Endoscope, Part: 11302BDX, with Instruction Manual: Z18443US - Product Usage: are intended to be used for examina…
  FDA Device · Class II · 2020-09-02 · Karl Storz Endoscopy
• ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 8¿
  FDA Device · Class II · 2020-09-02 · Globus Medical
• VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic use only - The TBIL test within the VITROS XT Chem…
  FDA Device · Class II · 2020-09-02 · Ortho Clinical Diagnostics
• VITROS XT7600 Integrated System, Product code 6844461
  FDA Device · Class II · 2020-09-02 · Ortho Clinical Diagnostics
• Klarity Vacuum Bags, Item Nos
  FDA Device · Class II · 2020-09-02 · Klarity Medical Products
• ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 8¿
  FDA Device · Class II · 2020-09-02 · Globus 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)