FDA Device · 2021
FDA Device recalls in 2021
RecallRadar indexes 2,303 FDA Device recall notices published in 2021. By classification: 179 Class I, 2,098 Class II, 26 Class III.
- Endometrial Biopsy Kit
FDA Device · Class II · 2021-10-27 · Stradis Medical - Standard IUD Insertion Kit
FDA Device · Class II · 2021-10-27 · Stradis Medical - Catalog # BEK3411, Ecomomy Jamshidi Bone Marrow Biopsy Tray, 11 G X 4"Biopsy/Aspiration needle, sterile, Qty: 10, Single Use Only, RX only
FDA Device · Class II · 2021-10-27 · Bard Peripheral Vascular - Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal Stent Dia…
FDA Device · Class II · 2021-10-20 · W L Gore And Associates - Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
FDA Device · Class I · 2021-10-20 · Abbott Molecular - smiths medical medex CBSS 5 ml, einfach proximaler Entnahmeport 60 cm, Model Number DPSHC0083
FDA Device · Class II · 2021-10-20 · Smiths Medical Asd - smiths medical medex CBSS-5ML Zweifach set, Model Number DPSHC0090
FDA Device · Class II · 2021-10-20 · Smiths Medical Asd - medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b) MX961E211P1 c) MX962E211P1 d) MX96AE181P1 e) MX96AE211P1
FDA Device · Class II · 2021-10-20 · Smiths Medical Asd - Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
FDA Device · Class I · 2021-10-20 · Abbott Molecular - smiths medical medex CBSS-5ML Antishunt set, (172/15cm), Model Number DPSHC0091
FDA Device · Class II · 2021-10-20 · Smiths Medical Asd - Philips, HeartStart FRx + Defibrillator, Model # Model #s: 861304
FDA Device · Class II · 2021-10-20 · Philips North America - cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
FDA Device · Class II · 2021-10-20 · Roche Molecular Systems - United Orthopedics USTAR II Knee System USTAR II Knee System Segment Part, RHS, 25 mm Length, Catalog # 2915-1025
FDA Device · Class II · 2021-10-20 · Uoc Usa - Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI:00886874115978
FDA Device · Class II · 2021-10-20 · Intuitive Surgical - ECO 85CB Lotion Ultrasound 8.5 oz 24/cs ECO 40JBC Gel Ultrasound Transmission Clr 8.5 oz BTL 24/cs ECO 40JMC Gel Ultrasound Transmission Cl…
FDA Device · Class I · 2021-10-20 · National Distribution And Contracting - EcoGel 200 - RED Medical Supplies Blue Ultrasound Gel, Model No. 250UG-BMU
FDA Device · Class I · 2021-10-20 · Red Medical Supplies - Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) up…
FDA Device · Class II · 2021-10-20 · Draeger Medical - Thoraguard Chest Tube Kit, 20 Fr
FDA Device · Class II · 2021-10-20 · Centese - Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A
FDA Device · Class II · 2021-10-20 · Philips North America - Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm
FDA Device · Class II · 2021-10-20 · Medtronic Sofamor Danek Usa - smiths medical medex CBSS-5ML, Single Set, (172/15cm), Model Number DPSHC0093
FDA Device · Class II · 2021-10-20 · Smiths Medical Asd - Philips, HeartStart HS1 Home Defibrillator, Model # Model number: M5068A
FDA Device · Class II · 2021-10-20 · Philips North America - Flower Lag Screw Kit 2.7 mm-intended to be used with 2.7mm lag screws and can be used with any plate that as part of the Flower Small and M…
FDA Device · Class II · 2021-10-20 · Flower Orthopedics - smiths medical medex CBSS 5 ml, Antishunt proximaler Entnahmeport 60 cm, Model Number DPSHC0081
FDA Device · Class II · 2021-10-20 · Smiths Medical Asd - ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser Btl
FDA Device · Class I · 2021-10-20 · National Distribution And Contracting - EcoGel 200 - RED Medical Supplies Clear Ultrasound Gel, Model No. 250UG-CMU
FDA Device · Class I · 2021-10-20 · Red Medical Supplies - smiths medical medex CBSS 5 ml, dreifach proximaler Entnahmeport 60 cm, Model number DPSHC0082
FDA Device · Class II · 2021-10-20 · Smiths Medical Asd - Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diag…
FDA Device · Class I · 2021-10-20 · Abbott Molecular - Elekta Medical Linear Accelerator (EMLA), configured as follows: a. Elekta Precise Digital Accelerator
FDA Device · Class II · 2021-10-20 · Elekta - Flower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and can be used with any plate that has been cleared as part of t…
FDA Device · Class II · 2021-10-20 · Flower Orthopedics - Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A
FDA Device · Class II · 2021-10-20 · Philips North America - Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
FDA Device · Class I · 2021-10-20 · Abbott Molecular - Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143
FDA Device · Class II · 2021-10-20 · Elekta Solutions Ab - smiths medical medex CBSS-5ML, Double set, (172+15cm), Model Number DPSHC0094
FDA Device · Class II · 2021-10-20 · Smiths Medical Asd - smiths medical medex CBSS-5ML, Triple set, (172/15cm), Model Number DPSHC0092
FDA Device · Class II · 2021-10-20 · Smiths Medical Asd - smiths medical medex CBSS 2-fach Druckmesset mit Option, Model Number DPSHC0076
FDA Device · Class II · 2021-10-20 · Smiths Medical Asd - Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients
FDA Device · Class II · 2021-10-20 · Draeger Medical - EcoGel 100 - RED Medical Supplies Green Ultrasound Gel, Model No. 250UG-GLU
FDA Device · Class I · 2021-10-20 · Red Medical Supplies - Flower Drill Bit Kit 2.7mm- The Drill Bit Kit, 2.7mm (DBK 027) is intended to be used with solid 2.7mm screws and can be used with any the…
FDA Device · Class II · 2021-10-20 · Flower Orthopedics - FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
FDA Device · Class II · 2021-10-20 · Inpeco - BioPlex 2200 ANA Screen Control Set, REF: 663-1131 incompatible with ANA Screen Reagent Packs/ANA Kits, REF: 665-1150
FDA Device · Class II · 2021-10-20 · Bio Rad Laboratories - smiths medical medex CBSS 5 ml, zweifach proximaler Entnahmeport 60 cm, Model Number DPSHC0084
FDA Device · Class II · 2021-10-20 · Smiths Medical Asd - Power Processor 3K, 3K High Speed Stockyards Module Nameplate: PP 3K Stockyard (Refrig) 9707 REF A88116
FDA Device · Class II · 2021-10-20 · Beckman Coulter - Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro di…
FDA Device · Class I · 2021-10-20 · Abbott Molecular - MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System
FDA Device · Class II · 2021-10-20 · Biomerieux - Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm
FDA Device · Class II · 2021-10-20 · Medtronic Sofamor Danek Usa - smiths medical medex HemoDraw Plus Closed Blood Sampling Set with LogiCal Pressure Monitoring System, Model Numbers: a) MX961H182P1 b) MX96…
FDA Device · Class II · 2021-10-20 · Smiths Medical Asd - Chesapeake Anterior Lumbar (AL) Removal Tool
FDA Device · Class II · 2021-10-20 · K2m - Flower Drill Bit Kit 2.4 mm-intended to be used with solid 2.4mm screws and can be used with any plate as part of the Flower Small and Medi…
FDA Device · Class II · 2021-10-20 · Flower Orthopedics - Zoll, REF 8700-000872-40, SOLEX 7(Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer
FDA Device · Class II · 2021-10-13 · Zoll Circulation - Zoll, REF 8700-000866-01, ICY IVTM Disposable Pack and Start UP Kit (6 ft.)
FDA Device · Class II · 2021-10-13 · Zoll Circulation - Zoll REF: 8700-0782-01 (IC-3893), ICY Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens) , Femo…
FDA Device · Class II · 2021-10-13 · Zoll Circulation - Zoll, REF 8700-000766-01, Quattro IVTM Premium Disposable Pack and Start UP Kit (6 ft.)
FDA Device · Class II · 2021-10-13 · Zoll Circulation - Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the Alinity c CRP Vari…
FDA Device · Class III · 2021-10-13 · Sentinel Ch Spa - Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep
FDA Device · Class II · 2021-10-13 · Nox Medical - CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: MCH-11TEC,CE 2797, UDI: (01) 00860000846134
FDA Device · Class II · 2021-10-13 · Cardioquip - Zoll REF: 8700-0783-14 (IC-4593CO), QUATTRO Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens),…
FDA Device · Class II · 2021-10-13 · Zoll Circulation - ZOLL, REF 8700-0781-14 (CL-2295CO), COOL LINE Intravascular Heat Exchange Catheter kit with central venous infusion capabilities (3 lumens)…
FDA Device · Class II · 2021-10-13 · Zoll Circulation - Zoll REF: 8700-0783-01 (IC-4593), QUATTRO Intravascular Heat Exchange Catheter Kit Custom Luer Applause Heparin, Sterile EO, Rx Only, UDI:…
FDA Device · Class II · 2021-10-13 · Zoll Circulation - Zoll, REF 8700-0781-03 (CL-2295AE), COOLINE Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capab…
FDA Device · Class II · 2021-10-13 · Zoll Circulation - Scan Abutment SP, Cat
FDA Device · Class II · 2021-10-13 · Paltop Advanced Dental Solutions - ZOLL, REF 8700-0793-40 (SL-2593AE) SOLEX 7, Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens),…
FDA Device · Class II · 2021-10-13 · Zoll Circulation - Scan Abutment MU, Cat
FDA Device · Class II · 2021-10-13 · Paltop Advanced Dental Solutions - Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX)
FDA Device · Class II · 2021-10-13 · Exactech - Zoll, REF 8700-000868-01, Solex 7 IVTM Disposable Pack and Start UP Kit (6 ft.)
FDA Device · Class II · 2021-10-13 · Zoll Circulation - OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information refl…
FDA Device · Class II · 2021-10-13 · Exactech - Zoll REF: 8700-0793-14 (SL-2593CO), SOLEX 7 Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens),…
FDA Device · Class II · 2021-10-13 · Zoll Circulation - OPTETRAK Comprehensive Knee System custom devices labeled as the following: a. CUSTOM OPTETRAK ANGLED PS INSERT (Product Line: 900-06-XX, 9…
FDA Device · Class II · 2021-10-13 · Exactech - Philips Ultrasound, Inc
FDA Device · Class II · 2021-10-13 · Philips Ultrasound - ZOLL, REF: 8700-0781-01 (CL-2295), COOL LINE, Intravascular Heat Exchange Catheter Kit Applause Custom Luer Heparin, STERILE EO, Rx only, U…
FDA Device · Class II · 2021-10-13 · Zoll Circulation - ZOLL, REF 8700-0781-40 (CL-2295AE), COOL LINE Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens)…
FDA Device · Class II · 2021-10-13 · Zoll Circulation - Zoll, REF 8700-0782-03 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilit…
FDA Device · Class II · 2021-10-13 · Zoll Circulation - ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLBUR280 and BUR280), Model Numbers: ELI280-DDB-ADAAX, ELI280-BDB…
FDA Device · Class II · 2021-10-13 · Welch Allyn Mortara - TECNIS Eyhance IOLs are permanent intraocular implants intended for implantation in the capsular bag
FDA Device · Class II · 2021-10-13 · Johnson And Johnson Surgical Vision - ARTHROFOCUS Polyethylene Tibial Inserts (Product Line: 256-12-XX, 256-13-XX). NOTE: Information reflects Exactech recall expansion initiate…
FDA Device · Class II · 2021-10-13 · Exactech - Scan Abutment NP, Cat
FDA Device · Class II · 2021-10-13 · Paltop Advanced Dental Solutions - Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue
FDA Device · Class I · 2021-10-13 · Aesthetics Systems Usa - Zoll REF: 8700-0783-40 (IC-4593AE), QUATTRO Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens),…
FDA Device · Class II · 2021-10-13 · Zoll Circulation - ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001
FDA Device · Class II · 2021-10-13 · Depuy Orthopaedics - Scan Abutment SU, Cat
FDA Device · Class II · 2021-10-13 · Paltop Advanced Dental Solutions - Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
FDA Device · Class II · 2021-10-13 · Datascope - ZOLL, REF 8700-0787-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), STER…
FDA Device · Class II · 2021-10-13 · Zoll Circulation - Philips Ultrasound, Inc
FDA Device · Class II · 2021-10-13 · Philips Ultrasound - CardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, CE 2797, UDI: (01) 00860000846127
FDA Device · Class II · 2021-10-13 · Cardioquip - Zoll, REF 8700-000869-40, Cool Line (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer
FDA Device · Class II · 2021-10-13 · Zoll Circulation - Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile
FDA Device · Class II · 2021-10-13 · Medtronic Perfusion Systems - Zoll, REF 8700-0657-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilit…
FDA Device · Class II · 2021-10-13 · Zoll Circulation - CardioQuip, Modular Cooler-Heater 1000(m),Compact Unit, Model:MCH-1000(m),CE 2797, UDI: (01)00860000846110
FDA Device · Class II · 2021-10-13 · Cardioquip - OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, with Product Line Numbers:…
FDA Device · Class II · 2021-10-13 · Exactech - Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
FDA Device · Class II · 2021-10-13 · Ge Healthcare - Zoll, REF 8700-000871-40, Quattro (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer
FDA Device · Class II · 2021-10-13 · Zoll Circulation - Zoll, REF 8700-0695-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilit…
FDA Device · Class II · 2021-10-13 · Zoll Circulation - Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
FDA Device · Class II · 2021-10-13 · Flower Orthopedics - Scan Abutment PCA, Cat
FDA Device · Class II · 2021-10-13 · Paltop Advanced Dental Solutions - Zoll, REF 8700-000867-01, Quattro IVTM Disposable Pack and Start UP Kit (6 ft.)
FDA Device · Class II · 2021-10-13 · Zoll Circulation - TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts
FDA Device · Class II · 2021-10-13 · Exactech - Scan Abutment WP, Cat
FDA Device · Class II · 2021-10-13 · Paltop Advanced Dental Solutions - Zoll REF: 8700-0782-14 (IC-3893CO), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPA…
FDA Device · Class II · 2021-10-13 · Zoll Circulation - OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-X…
FDA Device · Class II · 2021-10-13 · Exactech - AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation (IRE) Device, 15 cm IRE Single Electrode RFID Acti…
FDA Device · Class II · 2021-10-13 · Angiodynamics
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)