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.
- NUCLISENS¿ Lysis Buffer, IVD, REF 200292, 48X2 ML LYS Manufacturer bioMerieux SA 376, Chemin de l'Orme 69280 Marcy-l'Etoile - France - Prod…
FDA Device · Class II · 2020-03-04 · Biomerieux Grenoble - Ambulance Parameter Extension (APE) kit M4758A, an accessory to the Philips HeartStart MRx Monitor/Defibrillator - Product Usage: is intend…
FDA Device · Class II · 2020-03-04 · Philips North America - CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 6MM(H) Reference Number: IEHA466
FDA Device · Class II · 2020-03-04 · Biomet 3i - Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350
FDA Device · Class II · 2020-03-04 · Medline Industries - MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, HydroSoft 3D, Sterile, Rx, REF numbers 100102HF…
FDA Device · Class II · 2020-03-04 · Microvention - CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 4MM(H) Reference Number: IEHA354
FDA Device · Class II · 2020-03-04 · Biomet 3i - MicroVention Terumo HydroFrame 18, HydroCoil Embolic System, Endovascular Embolization Coil, Sterile, Rx, REF numbers 180723HFRM-V, 180931H…
FDA Device · Class II · 2020-03-04 · Microvention - Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used in a cemented total knee prosthesis system, which provi…
FDA Device · Class II · 2020-03-04 · Exactech - MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Helical 10 Soft, Sterile, Rx, REF numbers 100206HCS…
FDA Device · Class II · 2020-03-04 · Microvention - CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 6MM(H) Reference Number: IEHA566
FDA Device · Class II · 2020-03-04 · Biomet 3i - Zimmer Sterile Disposable Tourniquet Cuff with Protective Sleeve and PLC, Dual Port, Dual Bladder, Item No. 60708015200, UDI (01)0088902437…
FDA Device · Class II · 2020-03-04 · Zimmer Surgical - MicroVention Terumo Microplex 18, Platinum Embolization Coil, Cosmos 18, Sterile, Rx, REF numbers 180619CS-V, 180723CS-V, 180827CS-V, 18093…
FDA Device · Class II · 2020-03-04 · Microvention - Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36QC (05414734507646), CD2411-36C (05414734507585), CD1277-36 (0…
FDA Device · Class II · 2020-03-04 · St Jude Medical Cardiac Rhythm Management Division - CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 3MM(H) Reference Number: IEHA453
FDA Device · Class II · 2020-03-04 · Biomet 3i - MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Compass 10, Sterile, Rx, REF numbers 100203CMSR-V,…
FDA Device · Class II · 2020-03-04 · Microvention - MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Helical 18 Regular, Sterile, Rx, REF numbers 180520…
FDA Device · Class II · 2020-03-04 · Microvention - Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-503 Product Usage: Used in facilities such as Central Sterile Supply De…
FDA Device · Class III · 2020-03-04 · Maquet Cardiovascular Us Sales - Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2. The DigiTrak XT Recorder is available in four different configurat…
FDA Device · Class II · 2020-03-04 · Philips North America - CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA564
FDA Device · Class II · 2020-03-04 · Biomet 3i - TLC-2000 Therapeutic Medical Laser System
FDA Device · Class III · 2020-03-04 · Theralase - Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is an endovascular graft
FDA Device · Class II · 2020-03-04 · Cook - Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, UDI 15420045505636
FDA Device · Class II · 2020-03-04 · Hologic - Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw
FDA Device · Class II · 2020-03-04 · Ulrich Medical Usa - Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-502 Product Usage: Used in facilities such as Central Sterile Supply De…
FDA Device · Class III · 2020-03-04 · Maquet Cardiovascular Us Sales - CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 3MM(H) Reference Number: IEHA443
FDA Device · Class II · 2020-03-04 · Biomet 3i - THP Hip Plating System, Item Nos. 14-451070 14-451075 14-451080 14-451085 14-451090 14-451095 14-451100 14-451105 14-451110 14-451115 14-45…
FDA Device · Class II · 2020-03-04 · Zimmer Biomet - MicroVention Terumo Microplex, Platinum Coil System, Endovascular Embolization Coil, VFC, Sterile, Rx, REF numbers MV-00306VFC, MV-00315VFC…
FDA Device · Class II · 2020-03-04 · Microvention - MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, HyperSoft 3D, Sterile, Rx, REF numbers 100102HS3D-V…
FDA Device · Class II · 2020-03-04 · Microvention - Polysorb Braided Absorbable Suture 0 30" UNDYED HOS-11, Item Code CL537 - Product Usage: Indicated for use in soft tissue approximation or…
FDA Device · Class II · 2020-02-26 · Covidien - Arrow FlexTip Plus(R) Combined Spinal Epidural Catheterization Kit ASK-05560-WH
FDA Device · Class II · 2020-02-26 · Arrow International - Polysorb Braided Absorbable Suture 1 36 VIOLET GS-21, Item Code CL925 - Product Usage: Indicated for use in soft tissue approximation or li…
FDA Device · Class II · 2020-02-26 · Covidien - Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533
FDA Device · Class II · 2020-02-26 · Siemens Healthcare Diagnostics - Drill Tapered WP 5x10 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy pr…
FDA Device · Class II · 2020-02-26 · Nobel Biocare Usa - Arrow EPIDURAL CATHETERIZATION KIT YC-02220
FDA Device · Class II · 2020-02-26 · Arrow International - Guided Start Drills/Counterbore NobRpl NP - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for prep…
FDA Device · Class II · 2020-02-26 · Nobel Biocare Usa - NC TREK Coronary Dilatation Catheter, REF 1012453-15 Rx Only, NC TREK RX 4.00 X 15MM BDC The NC TREK RX Coronary Dilatation Catheter is ind…
FDA Device · Class I · 2020-02-26 · Abbott Vascular - Trilogy EVO Ventilator, Iberia - Model Number: ES2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.…
FDA Device · Class I · 2020-02-26 · Philips Respironics - Polysorb Braided Absorbable Suture 6-0 18" UNDYED SS-24 D/A, Item Code L2752K - Product Usage: Indicated for use in soft tissue approximati…
FDA Device · Class II · 2020-02-26 · Covidien - Trilogy EVO Ventilator, France - Model Number: FR2110X14B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.…
FDA Device · Class I · 2020-02-26 · Philips Respironics - Implant Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have specific intended us…
FDA Device · Class II · 2020-02-26 · Nobel Biocare Usa - ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein (hsCRP) Calibrator - product Usage: For in vitro diagnostic use in the cali…
FDA Device · Class II · 2020-02-26 · Siemens Healthcare Diagnostics - Arrow Pressure Injectable Two-Lumen PICC Kit 5 Fr. x 50 cm EU-05052-HPMSB
FDA Device · Class II · 2020-02-26 · Arrow International - Polysorb Braided Absorbable Suture 2/0 30"VIOLET GU-46, Item Code UL878 - Product Usage: Indicated for use in soft tissue approximation or…
FDA Device · Class II · 2020-02-26 · Covidien - Garbin EVO Ventilator, Linde - Model Number: LD2110X23B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5…
FDA Device · Class I · 2020-02-26 · Philips Respironics - Polysorb Braided Absorbable Suture 2-0 VIOLET 30" V-20, Item Code GL123 - Product Usage: Indicated for use in soft tissue approximation or…
FDA Device · Class II · 2020-02-26 · Covidien - i-STAT CHEM8+ cartridges (blue), List No. 09P31-25
FDA Device · Class II · 2020-02-26 · Abbott Point - Polysorb Braided Absorbable Suture 2 36" VIOLET GS-24, Item Code CL911 - Product Usage: Indicated for use in soft tissue approximation or l…
FDA Device · Class II · 2020-02-26 · Covidien - Dense Bone Drill NP 3.5x16 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteoto…
FDA Device · Class II · 2020-02-26 · Nobel Biocare Usa - Polysorb Braided Absorbable Suture 0 30" VIOLET GU-46, Item Code UL877 - Product Usage: Indicated for use in soft tissue approximation or l…
FDA Device · Class II · 2020-02-26 · Covidien - ARTIS Pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000 - Product Usage:AXIOM Artis is a family of dedicated angiograph…
FDA Device · Class II · 2020-02-26 · Siemens Medical Solutions Usa - Polysorb Braided Absorbable Suture 4/0 30 VIO SC-2 124K, Item Code SL654 - Product Usage: Indicated for use in soft tissue approximation or…
FDA Device · Class II · 2020-02-26 · Covidien - UST-2265-2 Probe, Part Number: UST-2265-2 - Product Usage: The UST-2265-2 probe is intended to be used for diagnostic ultrasound imaging or…
FDA Device · Class II · 2020-02-26 · Hitachi Medical Systems America - Drill Tapered RP 4.3x13 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparin…
FDA Device · Class II · 2020-02-26 · Nobel Biocare Usa - Polysorb Braided Absorbable Suture 0 36 VIOLET GS-24, Item Code CL914 - Product Usage: Indicated for use in soft tissue approximation or li…
FDA Device · Class II · 2020-02-26 · Covidien - NC TRAVELER Coronary Dilatation Catheter, REF 1013157-12, Rx Only,NC Traveler RX 4.0 X 12MM The NC Traveler RX Coronary Dilatation Catheter…
FDA Device · Class I · 2020-02-26 · Abbott Vascular - Philips HeartStart HS1 Onsite (Model M5066A) and HSI Home (Model M5068A) AED, Model 861304, HSI codeRev: E.03.063
FDA Device · Class II · 2020-02-26 · Philips North America - Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery Item Code: EGIAUSTND
FDA Device · Class II · 2020-02-26 · Covidien - Arrow EPIDURAL NEEDLE KIT SL-05500
FDA Device · Class II · 2020-02-26 · Arrow International - 1 STRATAFIX" Spiral PDS Plus Violet 12" (30 cm) CT-1 Needle, SXPP1B429
FDA Device · Class II · 2020-02-26 · Ethicon - Trilogy EVO Ventilator, 02 - Italy - Model Number: IT2100X21B Trilogy Evo is intended for pediatric through adult patients weighing at leas…
FDA Device · Class I · 2020-02-26 · Philips Respironics - EDAN Telemetry Transmitter, Model iT20 - Product Usage: The iT20 telemetry transmitter is intended to be used in clinical divisions of hosp…
FDA Device · Class II · 2020-02-26 · Edan Diagnostics - Polysorb Braided Absorbable Suture 1 30 VIOLET GS-22, Item Code CL885 - Product Usage: Indicated for use in soft tissue approximation or li…
FDA Device · Class II · 2020-02-26 · Covidien - NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indi…
FDA Device · Class I · 2020-02-26 · Abbott Vascular - Polysorb Braided Absorbable Suture 2-0 UNDYED 36" GS-21, Item Code CL953 - Product Usage: Indicated for use in soft tissue approximation or…
FDA Device · Class II · 2020-02-26 · Covidien - Polysorb Braided Absorbable Suture 2/0 UNDYED 30" V-30 (75CM), Item Code GL228 - Product Usage: Indicated for use in soft tissue approximat…
FDA Device · Class II · 2020-02-26 · Covidien - Abutment Screw Retrieval Instrument 3.0/NP - Product Usage: The instruments for abutment screw retrieval can be used if an abutment screw i…
FDA Device · Class II · 2020-02-26 · Nobel Biocare Usa - i-STAT CG4+ cartridge (blue), List No. 03P85-50
FDA Device · Class II · 2020-02-26 · Abbott Point - NC TREK Coronary Dilatation Catheter, REF 1012455-08 Rx Only, NC TREK RX 5.00 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indi…
FDA Device · Class I · 2020-02-26 · Abbott Vascular - Abutment Screw Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have specific inte…
FDA Device · Class II · 2020-02-26 · Nobel Biocare Usa - Pentax Video Colonoscope Model: EC34-i10L
FDA Device · Class II · 2020-02-26 · Pentax - Pentax Video Colonoscope Model: EC38-i10L
FDA Device · Class II · 2020-02-26 · Pentax - Polysorb Braided Absorbable Suture 1 36 VIOLET GS-24, Item Code CL915 - Product Usage: Indicated for use in soft tissue approximation or li…
FDA Device · Class II · 2020-02-26 · Covidien - NC TREK Coronary Dilatation Catheter, REF 1012454-20 Rx Only, NC TREK RX 4.50 X 20MM BDC The NC TREK RX Coronary Dilatation Catheter is ind…
FDA Device · Class I · 2020-02-26 · Abbott Vascular - Dense Bone Drill 6.0 6x16 mm Single-Pat- Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for prepari…
FDA Device · Class II · 2020-02-26 · Nobel Biocare Usa - CombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose
FDA Device · Class II · 2020-02-26 · Philips Medical Systems Dmc - NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.00 X 20MM BDC The NC TREK RX Coronary Dilatation Catheter is ind…
FDA Device · Class I · 2020-02-26 · Abbott Vascular - Arrow EPIDURAL NEEDLE COMPONENT AN-05505
FDA Device · Class II · 2020-02-26 · Arrow International - Arrow EPIDURAL CATHETERIZATION KIT JH-05500
FDA Device · Class II · 2020-02-26 · Arrow International - NC TREK Coronary Dilatation Catheter, REF 1012453-12 Rx Only, NC TREK RX 4.00 X 12MM BDC The NC TREK RX Coronary Dilatation Catheter is ind…
FDA Device · Class I · 2020-02-26 · Abbott Vascular - Trilogy EVO Ventilator, 02 - Iberia - Model Number: ES2100X15B Trilogy Evo is intended for pediatric through adult patients weighing at lea…
FDA Device · Class I · 2020-02-26 · Philips Respironics - Implant Retrieval Instrument Hex & Tri-Chi NP/RP 31mm - Product Usage: They can be used to remove implants, if the implant connection has b…
FDA Device · Class II · 2020-02-26 · Nobel Biocare Usa - Arrow Maximal Barrier Drape ASK-00002-1A
FDA Device · Class II · 2020-02-26 · Arrow International - Arrow Central Venous Catheterization Kit ASK-04200-UPM
FDA Device · Class II · 2020-02-26 · Arrow International - DP-30 Digital Ultrasonic Diagnostic Imaging System, Part No. 1155E-PA00004 - Product Usage: The Digital Ultrasonic Diagnostic Imaging Syste…
FDA Device · Class II · 2020-02-26 · Mindray Ds Usa - Screw Tap Tapered WP Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing oste…
FDA Device · Class II · 2020-02-26 · Nobel Biocare Usa - Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05500-CAN
FDA Device · Class II · 2020-02-26 · Arrow International - Polysorb Braided Absorbable Suture UD 3/0 30 P-14, Item Code SL5679 - Product Usage: Indicated for use in soft tissue approximation or liga…
FDA Device · Class II · 2020-02-26 · Covidien - Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440
FDA Device · Class II · 2020-02-26 · Teleflex Medical - Polysorb Braided Absorbable Suture 6/0 18" UNDYED P-10, Item Code SL1625G - Product Usage: Indicated for use in soft tissue approximation o…
FDA Device · Class II · 2020-02-26 · Covidien - Trilogy EVO Ventilator, EU - Model Number: EU2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg
FDA Device · Class I · 2020-02-26 · Philips Respironics - Drill Tapered NP 3.5x10 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparin…
FDA Device · Class II · 2020-02-26 · Nobel Biocare Usa - Arrow SPINAL ANESTHESIA SET ASA-25090-S
FDA Device · Class II · 2020-02-26 · Arrow International - NC TREK Coronary Dilatation Catheter, REF 1012454-15 Rx Only, NC TREK RX 4.50 X 15MM BDC The NC TREK RX Coronary Dilatation Catheter is ind…
FDA Device · Class I · 2020-02-26 · Abbott Vascular - SnapLink, Ref Part No. 438-2191, L6L SnapLink, Slot .022, TQ--28, Ang +2, Rot +2, Qty 10, Made in Mexico, CE 0086, Rx Only
FDA Device · Class II · 2020-02-26 · Ormco Sybronendo - Drill Tapered NP 3.5x8 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing…
FDA Device · Class II · 2020-02-26 · Nobel Biocare Usa - NC TREK Coronary Dilatation Catheter, REF 1012455-15 Rx Only,NC TREK RX 5.00 X 15MM BDC The NC TREK RX Coronary Dilatation Catheter is indi…
FDA Device · Class I · 2020-02-26 · Abbott Vascular - Arrow EPIDURAL CATHETERIZATION KIT AM-05500
FDA Device · Class II · 2020-02-26 · Arrow International - Trilogy EVO Ventilator, 02 - International - Model Number: IN2100X15B Trilogy Evo is intended for pediatric through adult patients weighing…
FDA Device · Class I · 2020-02-26 · Philips Respironics - Polysorb Braided Absorbable Suture 13-0 VIOLET 30" GS-23, Item Code CL892 - Product Usage: Indicated for use in soft tissue approximation o…
FDA Device · Class II · 2020-02-26 · Covidien - Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 1…
FDA Device · Class II · 2020-02-26 · Cardinal Health 200
Other years
2026 (2,088) · 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)