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.
- Maestro Orthodontic Bracket REF711-298Q QTY. 20 Rx Only (01)00190707017064 (10)889437 (422)484 Maestro Orthodontic Bracket REF711-299MCQ QT…
FDA Device · Class II · 2020-07-08 · Ortho Organizers - Sterile Disposable Connectors ASY 1/2 CONN W/LL STRLE 24 REF/ GTIN for Insert Label:050608000/ 00803622123382
FDA Device · Class II · 2020-07-08 · Livanova Usa - VITROS XT 7600 Integrated System Software Versions 3.5.1 and below Product Code:6844461 Unique Identifier: 10758750031610
FDA Device · Class II · 2020-07-08 · Ortho Clinical Diagnostics - Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE SPANISH, Product Code IAP-0500E
FDA Device · Class I · 2020-07-08 · Arrow International - Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/AJLA, Product Code IAP-0701
FDA Device · Class I · 2020-07-08 · Arrow International - Isolation Droplet Bundle Kit
FDA Device · Class II · 2020-07-08 · Roi Cps - Arrow AutoCAT2 Intra-Aortic Balloon Pump AEROAUTOCAT 2 WAVE, Product Code IAP-0535
FDA Device · Class I · 2020-07-08 · Arrow International - Sterile Disposable Connectors ASY 1/4 X 3/8 REDUCER W/LL 24
FDA Device · Class II · 2020-07-08 · Livanova Usa - PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7983G FV768 FV769 FV7771 U7058 U7059 W1782 W1784 W1819 W1820 W818…
FDA Device · Class II · 2020-07-08 · Ethicon - Siemens IMMULITE 2000 Immunoassay System - In vitro Chemistry Analyzer SMN #10380062 - Product Usage: are intended for professional use in…
FDA Device · Class II · 2020-07-08 · Siemens Healthcare Diagnostics - Sterile Disposable Connectors ASY STR CONN 1/4 STRLE 24
FDA Device · Class II · 2020-07-08 · Livanova Usa - Sterile Disposable Connectors ASY CONN EQUAL 3/16 WYE 24 REF/ GTIN for Insert Label:050523000/ 00803622123290
FDA Device · Class II · 2020-07-08 · Livanova Usa - 3/8 STR CONN, STRL REF/ GTIN for Insert Label:EC2130S/ 00803622129292
FDA Device · Class II · 2020-07-08 · Livanova Usa - 1/4X3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2140S/ 00803622129315
FDA Device · Class II · 2020-07-08 · Livanova Usa - Sterile Disposable Connectors ASY RDC Y 1/2X3/8X3/8 STR 24 REF/ GTIN for Insert Label:050529000/ 00803622123351
FDA Device · Class II · 2020-07-08 · Livanova Usa - Sterile Disposable Connectors ASY STR CONN 3/16 STRLE 24
FDA Device · Class II · 2020-07-08 · Livanova Usa - BodyGuardian Heart Remote Monitoring Kit, consisting of two BG Heart monitors, either Models BC-1001-A or BC1001-D, and a cell phone, eithe…
FDA Device · Class II · 2020-07-08 · Preventice Services - uCT 530 Computed Tomography X-Ray System
FDA Device · Class II · 2020-07-08 · Shanghai United Imaging Healthcare - Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887
FDA Device · Class II · 2020-07-08 · Elekta Instrument Ab - 1/2 - 3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2145S/ 00803622129322
FDA Device · Class II · 2020-07-08 · Livanova Usa - Neo-Vent Infant T-Piece Resuscitation Circuit;Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector
FDA Device · Class II · 2020-07-08 · Westmed - Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE, Product Code IAP-0500
FDA Device · Class I · 2020-07-08 · Arrow International - Respirator Crash Cart Kit
FDA Device · Class II · 2020-07-08 · Roi Cps - ABL80-FLEX-393-839 Box Label, REF 393-839, IVD, CE, UDI: 05700693938394 - Product Usage: It is intended for use in a laboratory environment…
FDA Device · Class II · 2020-07-08 · Radiometer Medical Aps - (1) Atellica Data Manager software version 1.0 Siemens Material Number (SMN): 11314237 (2) Atellica Data Manager software version 1.1 Sieme…
FDA Device · Class II · 2020-07-08 · Siemens Healthcare Diagnostics - 1/4X3/16X3/16YCONN,STRL REF/ GTIN for Insert Label:EC2102S/ 00803622129278
FDA Device · Class II · 2020-07-08 · Livanova Usa - Elekta Unity, Image-Guided Radiation Therapy System
FDA Device · Class II · 2020-07-08 · Elekta - DIRECT SUPPLY Attendant VITAL SIGNS MONITOR, REF AVSM2 - Product Usage: It is vital sign monitor to monitor noninvasive blood pressure (NIB…
FDA Device · Class II · 2020-07-08 · Mediana - Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE DUTCH, Product Code IAP-0500NL
FDA Device · Class I · 2020-07-08 · Arrow International - Vein Irrigation Cannula with blunt tip
FDA Device · Class II · 2020-07-08 · Livanova Usa - Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 SPANISH, Product Code IAP-0400E
FDA Device · Class I · 2020-07-08 · Arrow International - Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA, Product Code IAP-0700
FDA Device · Class I · 2020-07-08 · Arrow International - VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier: 10758750002979
FDA Device · Class II · 2020-07-08 · Ortho Clinical Diagnostics - VITROS 3600 Immunodiagnostic System - Refurbished Product Code: 6802914 Unique Identifier: 10758750007103
FDA Device · Class II · 2020-07-08 · Ortho Clinical Diagnostics - Mueller Sports Medicine Hybrid Wraparound Knee Support, Qty: 1 unit per box
FDA Device · Class II · 2020-07-08 · Mueller Sports Medicine - Vein Irrigation Cannula with blunt tip
FDA Device · Class II · 2020-07-08 · Livanova Usa - ABL80-FLEX CO-OX 393-841 Box Label, REF 393-841, IVD, CE, UDI: 05700693938417 - Product Usage: It is intended for use in a laboratory envir…
FDA Device · Class II · 2020-07-08 · Radiometer Medical Aps - Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS Software (Server)
FDA Device · Class II · 2020-07-08 · Fujifilm Medical Systems U - Sterile Disposable Connectors ASY CONN REDUCER 1/2 X 3/8 24 REF/ GTIN for Insert label:050518000/ 00803622123283
FDA Device · Class II · 2020-07-08 · Livanova Usa - Control Panel REF - 60-02-50: LivaNova SCP Pump Control Panel S5/C5. REF 60-02-50, IPX2, RxOnly, UDI: 04033817900993
FDA Device · Class II · 2020-07-08 · Livanova Deutschland - (1) CentraLink Data Management System software version 16.0.2 Siemens Material Number (SMN): 11313246 (2) CentraLink Data Management System…
FDA Device · Class II · 2020-07-08 · Siemens Healthcare Diagnostics - 3/8X3/8X3/8 Y CONN, STRL REF/ GTIN for Insert Label:EC2105S/ 00803622129285
FDA Device · Class II · 2020-07-08 · Livanova Usa - Sterile Disposable Connectors ASY Y CONN 3/8 X 3/8 X 3/8 24 REF/ GTIN for Insert Label:050526000/ 00803622123320
FDA Device · Class II · 2020-07-08 · Livanova Usa - Sterile Disposable Connectors ASY CONN Y 1/2X1/2X3/8 STR 24
FDA Device · Class II · 2020-07-08 · Livanova Usa - Sterile Disposable Connectors ASY 3/16 X 3/16 STR CONNW/LL24
FDA Device · Class II · 2020-07-08 · Livanova Usa - Sterile Disposable Connectors ASY S/1/4 TO 3/16 RED 24 REF/ GTIN for Insert Label:050514000/00803622123269
FDA Device · Class II · 2020-07-08 · Livanova Usa - Sterile Disposable Connectors ASY S CONN 3/16X1/8 RDR ANLD24 REF/ GTIN for Insert Label:050513000/ 00803622123252
FDA Device · Class II · 2020-07-08 · Livanova Usa - Sterile Disposable Connectors ASY CONN REDUCER 3/8 X 1/4 24 REF/ GTIN for Insert Label:050516000/ 00803622123276
FDA Device · Class II · 2020-07-08 · Livanova Usa - Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT 2, Product Code IAP-0400
FDA Device · Class I · 2020-07-08 · Arrow International - Neo-Vent Infant T-Piece Resuscitation Circuit With Infant Mask
FDA Device · Class II · 2020-07-08 · Westmed - Pediatric Adjustable Flange Tracheostomy Tube Cuffless
FDA Device · Class II · 2020-07-08 · Smiths Medical Asd - Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Workstation Software Release - Product Usage:…
FDA Device · Class II · 2020-07-01 · Merge Healthcare - Utak NR Trace Elements Serum Control, 5 ml, REF 66816
FDA Device · Class III · 2020-07-01 · Utak Laboratories - LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1
FDA Device · Class II · 2020-07-01 · Zest Anchors - RP500e Handheld Barcode Scanner, Zebra Model: DS4308 - HC0062BZZWW, Siemens Material Number (SMN) 11416778
FDA Device · Class II · 2020-07-01 · Siemens Healthcare Diagnostics - BioPince Full Core Biopsy Instrument 16ga x 15cm.,Use with Optional CO-Axial Needle MCXS1615BP. QTY.: 5/CS - Product Usage: The disposable,…
FDA Device · Class II · 2020-07-01 · Argon Medical Devices - CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro, Model Numb…
FDA Device · Class II · 2020-07-01 · Ge Healthcare - Atellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00630414007960
FDA Device · Class II · 2020-07-01 · Siemens Healthcare Diagnostics - ADVIA Chemistry Calibrator
FDA Device · Class II · 2020-07-01 · Siemens Healthcare Diagnostics - HYGENIC Wingless Fiesta Kit, Model no
FDA Device · Class II · 2020-07-01 · Coltene Whaledent - Atellica CH Chemistry Calibrator
FDA Device · Class II · 2020-07-01 · Siemens Healthcare Diagnostics - HYGENIC Dental Dam Forceps, Model no
FDA Device · Class II · 2020-07-01 · Coltene Whaledent - AIA-900 Analyzer, Part no. 022930, UDI 04560189283992
FDA Device · Class II · 2020-07-01 · Tosoh Bioscience - HYGENIC Winged Fiesta Kit, Model no
FDA Device · Class II · 2020-07-01 · Coltene Whaledent - Atellica Solution IM1600 Analyzer, Siemens Material Number 11066000, UDI # 00630414002026
FDA Device · Class II · 2020-07-01 · Siemens Healthcare Diagnostics - MEVION S250i, MEVION S250
FDA Device · Class II · 2020-07-01 · Mevion Medical Systems - Ally Bone Screw - Product Usage:Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture re…
FDA Device · Class II · 2020-07-01 · Providence Medical Technologies - Oscar 2, Model 250 System
FDA Device · Class II · 2020-07-01 · Suntech Medical - RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs) model no. 8.0, 8.1, 9…
FDA Device · Class II · 2020-07-01 · Raysearch Laboratories Ab - Lokomat Pro, Catalog Numbers 30003 LokomatPro L6.2 120V AD
FDA Device · Class II · 2020-07-01 · Hocoma Ag - HYGENIC Simple Dam Kit, Model no. 60019066 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber d…
FDA Device · Class II · 2020-07-01 · Coltene Whaledent - VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/90 SLDS, Product Code 8112724, UDI # 10758750004393 - Product Usage: For in vi…
FDA Device · Class II · 2020-06-24 · Ortho Clinical Diagnostics - Stryker 1 End Cap T2 Humerus ¿6mm, 5mm height Catalog Number: 18300005S - Product Usage: Stryker implants are single use devices intended f…
FDA Device · Class II · 2020-06-24 · Stryker - Medtronic Bone Void Filler, Large - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler
FDA Device · Class II · 2020-06-24 · Medtronic Sofamor Danek Usa - Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II)
FDA Device · Class II · 2020-06-24 · Abaxis - DDU-2300 Lifeline/ReviveR View, Model Numbers DDU-C2300EN, DDU-C2300CA, DDU-A2300EN, DDU-E2300EN Catalog Numbers CCD-A1006RX CCD-A1013EN CC…
FDA Device · Class II · 2020-06-24 · Defibtech - Stryker End Cap T2 Humerus ¿6mm, 15mm height Catalog Number: 18300015S - Product Usage: Stryker implants are single use devices intended fo…
FDA Device · Class II · 2020-06-24 · Stryker - Stryker Locking Screw, Fully Threaded T2 Humerus ¿4x32 mm Catalog Number: 18964032S - Product Usage: Stryker implants are single use device…
FDA Device · Class II · 2020-06-24 · Stryker - Biomet Screw Instrument Tray 6.5/80MM- Surgical Tray Product Code: 246111003
FDA Device · Class II · 2020-06-24 · Biomet - VITROS Chemistry Product Performance Verifier II, Product Code 8067324, UDI # 10758750004317 - Product Usage: For in vitro diagnostic use o…
FDA Device · Class II · 2020-06-24 · Ortho Clinical Diagnostics - Stryker End Cap, Std, Ti Gamma3 Catalog Number: 30051100S - Product Usage: Stryker implants are single use devices intended for the tempora…
FDA Device · Class II · 2020-06-24 · Stryker - VITROS Chemistry Product Performance Verifier I, Product Code 8231474, UDI # 10758750004577 - Product Usage: For in vitro diagnostic use on…
FDA Device · Class II · 2020-06-24 · Ortho Clinical Diagnostics - Regard SRHS Central Line Kit, Sterile, 20/case - Product Usage: The Saline Flush Syringes are intended to be used only for the flushing of…
FDA Device · Class II · 2020-06-24 · Resource Optimization And Innovation - Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x30 mm Catalog Number: 18965030S - Product Usage: Stryker implants are single use devices…
FDA Device · Class II · 2020-06-24 · Stryker - Stryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - Product Usage: Stryker implants are single use devices intended fo…
FDA Device · Class II · 2020-06-24 · Stryker - Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x40 mm Catalog Number: 18965040S - Product Usage: Stryker implants are single use devices…
FDA Device · Class II · 2020-06-24 · Stryker - Stryker Locking Screw, Fully Threaded S2 05x35 mm Catalog Number: 17965035S - Product Usage: Stryker implants are single use devices intend…
FDA Device · Class II · 2020-06-24 · Stryker - MAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be used for mammography exams, screening, diagnostics, biopsies and…
FDA Device · Class II · 2020-06-24 · Siemens Medical Solutions Usa - Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x45 mm Catalog Number: 18965045S - Product Usage: Stryker implants are single use devices…
FDA Device · Class II · 2020-06-24 · Stryker - Stryker End Cap T2 Tibia +10 mm Catalog Number: 18220010S - Product Usage: Stryker implants are single use devices intended for the tempora…
FDA Device · Class II · 2020-06-24 · Stryker - Medtronic Bone Void Filler, Small - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler
FDA Device · Class II · 2020-06-24 · Medtronic Sofamor Danek Usa - Leica ARveo and M530 OH6 microscope systems
FDA Device · Class II · 2020-06-24 · Leica Microsystems - PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usage: The Biosense Webster PENTARAY NAV High-Densi…
FDA Device · Class II · 2020-06-24 · Biosense Webster - Alinity C, Processing Module
FDA Device · Class II · 2020-06-24 · Abbott And Kg - Stryker End Cap, Standard T2 Humerus ¿6 mm Catalog Number: 18300003S - Product Usage: Stryker implants are single use devices intended for…
FDA Device · Class II · 2020-06-24 · Stryker - BioFlo Midline Catheter and BioFlo Maximal Barrier Kits - Product Usage: These introducers are used for the percutaneous introduction of di…
FDA Device · Class II · 2020-06-24 · Angiodynamics - Mueller Knife Handle, Hexagonal - Product Usage: Intended to hold surgical blades
FDA Device · Class II · 2020-06-24 · Carefusion 2200 - BioFlo PICC and Xcela PICC Maximal Barrier Nursing Kits - Product Usage: are indicated for short or long-term peripheral access to the cent…
FDA Device · Class II · 2020-06-24 · Angiodynamics - Regard SRHS GIC Port A Cath, Sterile, Qty 20/case - Product Usage: The Saline Flush Syringes are intended to be used only for the flushing…
FDA Device · Class II · 2020-06-24 · Resource Optimization And Innovation - Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices…
FDA Device · Class II · 2020-06-24 · Stryker
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)