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.
- BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476
FDA Device · Class II · 2021-07-21 · Axonics Modulation Technologies - Discovery MR750 3.0T - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise…
FDA Device · Class II · 2021-07-21 · Ge Healthcare - INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273
FDA Device · Class I · 2021-07-21 · Boston Scientific - A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting
FDA Device · Class I · 2021-07-21 · Philips Respironics - Nonsterile Femoral Angiography Drape, Catalog Numbers: a) 29460NB, b) 29456NB - Product Usage: intended to be used as protective patient co…
FDA Device · Class II · 2021-07-14 · Cardinal Health 200 - Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11067000
FDA Device · Class II · 2021-07-14 · Siemens Healthcare Diagnostics - FilmArray Pneumonia Panel plus (Pneumoplus) Part Numbers: Part No: RFIT-ASY-0143 / UDI: 00815381020314 (30 test kit) Part No: RFIT-ASY-0142…
FDA Device · Class II · 2021-07-14 · Biofire Diagnostics - The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723034, is an automated, clinical chemistry analyzer that runs te…
FDA Device · Class II · 2021-07-14 · Siemens Healthcare Diagnostics - Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number: 20-006-024
FDA Device · Class II · 2021-07-14 · Luminex - HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)
FDA Device · Class II · 2021-07-14 · Liebel Flarsheim - Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Number 29442 - Product Usage: intended to be used as protective pat…
FDA Device · Class II · 2021-07-14 · Cardinal Health 200 - Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R
FDA Device · Class II · 2021-07-14 · Randox Laboratories - Revolution CT
FDA Device · Class II · 2021-07-14 · Ge Healthcare - FilmArray Pneumonia Panel (Pneumo) Part Numbers: Part No: RFIT-ASY-0144 / UDI: 00815381020178 (30 test kit) Part No: RFIT-ASY-0145 / UDI: 0…
FDA Device · Class II · 2021-07-14 · Biofire Diagnostics - CoreValve Evolut R Delivery Catheter System, REF: ENVEOR-L
FDA Device · Class II · 2021-07-14 · Medtronic Heart Valves Division - Sterile Radial/Femoral Angiography Drape, Catalog Number 29529 - Product Usage: intended to be used as protective patient coverings, such a…
FDA Device · Class II · 2021-07-14 · Cardinal Health 200 - Atellica IM 1300 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066001
FDA Device · Class II · 2021-07-14 · Siemens Healthcare Diagnostics - FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie Leichtkette (Human) kit for Roche cobas c Systems, REF: LK0…
FDA Device · Class II · 2021-07-14 · The Binding Site Group - Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331
FDA Device · Class II · 2021-07-14 · Boston Scientific - Sterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525 - Product Usage: intended to be used as protective patient coveri…
FDA Device · Class II · 2021-07-14 · Cardinal Health 200 - ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures
FDA Device · Class II · 2021-07-14 · Siemens Medical Solutions Usa - Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022
FDA Device · Class II · 2021-07-14 · Luminex - Nonsterile Radial/Femoral Angiography Drape, Catalog Number 29529N - Product Usage: intended to be used as protective patient coverings, su…
FDA Device · Class II · 2021-07-14 · Cardinal Health 200 - Nonsterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525N - Product Usage: intended to be used as protective patient co…
FDA Device · Class II · 2021-07-14 · Cardinal Health 200 - ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) REF 1667001
FDA Device · Class III · 2021-07-14 · Sentinel Ch Spa - Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722
FDA Device · Class II · 2021-07-14 · Boston Scientific - Atellica IM 1600 Analyzer- multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066000
FDA Device · Class II · 2021-07-14 · Siemens Healthcare Diagnostics - Sterile Femoral Angiography Drape, Catalog Numbers: a) 29460, b) 29456 - Product Usage: intended to be used as protective patient coverings…
FDA Device · Class II · 2021-07-14 · Cardinal Health 200 - The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from…
FDA Device · Class II · 2021-07-14 · Ge Healthcare - Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) Model Number: 20-006-026
FDA Device · Class II · 2021-07-14 · Luminex - CoreValve Evolut PRO Delivery Catheter System, REF: ENVPRO-14
FDA Device · Class II · 2021-07-14 · Medtronic Heart Valves Division - VALITUDE CRT-P pacemaker, Models: a) U125 b) U128
FDA Device · Class II · 2021-07-14 · Boston Scientific - The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from…
FDA Device · Class II · 2021-07-14 · Ge Healthcare - CoreValve Evolut PRO PLUS Delivery Catheter System, REF: D-EVPROP2329US
FDA Device · Class II · 2021-07-14 · Medtronic Heart Valves Division - VISIONIST CRT-P pacemaker, Models: a) U225 b) U226 c) U228
FDA Device · Class II · 2021-07-14 · Boston Scientific - Proponent pacemaker, Models: a) L200 b) L201 c) L209 d) L210 e) L211 f) L221 g) L231
FDA Device · Class II · 2021-07-14 · Boston Scientific - Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: 20-006-018
FDA Device · Class II · 2021-07-14 · Luminex - The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at differe…
FDA Device · Class II · 2021-07-14 · Ge Healthcare - Vivorte Trabexus EB 10 cc Bone Void Filler -Fill bone and/or defect in skeletal system Model Number: 130703-10
FDA Device · Class II · 2021-07-14 · Vivorte - Essentio pacemaker, Models: a) L100 b) L101 c) L110 d) L111 e) L121 f) L131
FDA Device · Class II · 2021-07-14 · Boston Scientific - Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023
FDA Device · Class II · 2021-07-14 · Luminex - Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021
FDA Device · Class II · 2021-07-14 · Luminex - Nonsterile Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Number 29442N - Product Usage: intended to be used as pr…
FDA Device · Class II · 2021-07-14 · Cardinal Health 200 - 5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm Guidewire Unit Label: PowerPICC REF CK000340B BARD MYPICC KIT 5F French Si…
FDA Device · Class II · 2021-07-07 · Bard Access Systems - Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728332 - IQon Spectral CT : IQon Spectral CT
FDA Device · Class II · 2021-07-07 · Philips North America - LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004
FDA Device · Class I · 2021-07-07 · Magellan Diagnostics - Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems: Model - MX800…
FDA Device · Class II · 2021-07-07 · Philips North America - Edwards TruWave (3 cc)/VAMP Jr 48 in (120 cm) Kit, REF: PXVJ356, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylen…
FDA Device · Class II · 2021-07-07 · Edwards Lifesciences - PERLA TL Lateral Connector Open - Product Usage: intended to be used with autograft and/or allograft
FDA Device · Class II · 2021-07-07 · Spineart - 5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: PowerPicc Polyurethand Radiology PiCC with Microintroducer
FDA Device · Class II · 2021-07-07 · Bard Access Systems - Edwards TruWave (3 cc)/VAMP Jr, REF: VMP406PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)07460691958746
FDA Device · Class II · 2021-07-07 · Edwards Lifesciences - Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882442/882456 - Ingenuity TF PET/CT
FDA Device · Class II · 2021-07-07 · Philips North America - Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882446 - Vereos PET/CT
FDA Device · Class II · 2021-07-07 · Philips North America - Synaptive Trackable Suction Set Standard and Malleable
FDA Device · Class II · 2021-07-07 · Synaptive Medical - Humeral Augmented Tray (HAT) trials that are components of KIT-321HAT. Each tray contains 1 of each of the following catalog numbers for a…
FDA Device · Class II · 2021-07-07 · Exactech - Edwards TruWave (30 cc)/VAMP Jr Kit, REF: VMP306PX, Pressure Monitoring Set, Rx Only, CE, UDI: (01)57460691950370
FDA Device · Class II · 2021-07-07 · Edwards Lifesciences - Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 7.5-10.0, Channel 1, Reference Numbers LSE4246MCA075 and LSE500M. for continuous…
FDA Device · Class II · 2021-07-07 · Spes Medica - Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent
FDA Device · Class I · 2021-07-07 · Quidel - Edwards REF: VJ0990, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691951520
FDA Device · Class II · 2021-07-07 · Edwards Lifesciences - Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882476 - Gemini TF Big Bore PET/CT
FDA Device · Class II · 2021-07-07 · Philips North America - Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm
FDA Device · Class II · 2021-07-07 · Remote Diagnostic Technologies - NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100
FDA Device · Class II · 2021-07-07 · Neumodx Molecular - Revolution EVO, Optima CT660, Optima CT680 CT Systems
FDA Device · Class II · 2021-07-07 · Ge Healthcare - Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728306 - Brilliance iCT 728311 - Brilliance iCT SP
FDA Device · Class II · 2021-07-07 · Philips North America - Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and MX16 Models: 728131
FDA Device · Class II · 2021-07-07 · Philips North America - Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems
FDA Device · Class II · 2021-07-07 · Philips North America - Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms
FDA Device · Class II · 2021-07-07 · Medtronic Vascular - Tripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D. Used during intraoperative neurological monitoring
FDA Device · Class II · 2021-07-07 · Spes Medica - Edwards TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit, REF: T443952B, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethyl…
FDA Device · Class II · 2021-07-07 · Edwards Lifesciences - Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728333 - Spectral CT
FDA Device · Class II · 2021-07-07 · Philips North America - LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098
FDA Device · Class I · 2021-07-07 · Magellan Diagnostics - Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 6.0-7.5, Channel 2, Reference Number LSE3463DCA200 and LSE500DCS-5. for continuou…
FDA Device · Class II · 2021-07-07 · Spes Medica - Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems
FDA Device · Class II · 2021-07-07 · Philips North America - LeadCare II Blood Lead Test Kit Catalog Number 70-6762
FDA Device · Class I · 2021-07-07 · Magellan Diagnostics - Edwards TruWave (30 cc)/VAMP Jr/52 in (132 cm) Kit, REF: PXVJ0711, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethyl…
FDA Device · Class II · 2021-07-07 · Edwards Lifesciences - MaxPlusTM bi fuse extension set with 2 clear needleless connectors - Product Usage: The needleless connector can be used for direct injecti…
FDA Device · Class II · 2021-07-07 · Carefusion - Edwards VAMP Jr. 6 in (15 cm) REF: VMP306, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691944782
FDA Device · Class II · 2021-07-07 · Edwards Lifesciences - SNS Disposable Urethral Catheter Electrode, 14 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesive with attached 2…
FDA Device · Class II · 2021-07-07 · Spes Medica - SNS Disposable Urethral Catheter Electrode, 10 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesive with attached 2…
FDA Device · Class II · 2021-07-07 · Spes Medica - Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems
FDA Device · Class II · 2021-07-07 · Philips North America - Physician Order Form (PL-15400-00, Nov. 2018) distributed to end user used with the following: Prometra Programmable Infusion Pump System:…
FDA Device · Class II · 2021-07-07 · Flowonix Medical - PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090 - Product Usage: intended for use in a controlled setting such as…
FDA Device · Class II · 2021-07-07 · Smiths Medical Asd - Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuit…
FDA Device · Class II · 2021-07-07 · Philips North America - Edwards TruWave 3 cc/VAMP Jr Kit, REF: VMP426PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)57460691950547
FDA Device · Class II · 2021-07-07 · Edwards Lifesciences - Probe Cover 6" x 96" regular PE w/ 3 Elastic Bands- Ultrasonic Transducer Cover Item ID: A-AU-0778NA
FDA Device · Class II · 2021-06-30 · Exact Medical Manufacturing - reSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment
FDA Device · Class II · 2021-06-30 · Pear Therapeutics - Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744
FDA Device · Class II · 2021-06-30 · Beckman Coulter - Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026, 722027, 722028, 722029, 722035, 722038, and 722058
FDA Device · Class II · 2021-06-30 · Philips Medical Systems Nederlands - inLight Medical LED Pads used with Polychromatic light technology system
FDA Device · Class III · 2021-06-30 · Inlightened Partners - Probe Cover, PE, Gel and Elastic bands, 6"x96"-Ultrasonic Transducer Cover Item ID: 1006664
FDA Device · Class II · 2021-06-30 · Exact Medical Manufacturing - Transducer Cover 15x147cm, Kit, VIP Film w/ Bands & EMM Gel Item ID: E6359
FDA Device · Class II · 2021-06-30 · Exact Medical Manufacturing - AEROCHAMBER PLS W/MASK LRG BLU Item Number: 1496033
FDA Device · Class II · 2021-06-30 · Cardinal Health - Probe Cover - 6" x 3" x 96"-Ultrasonic Transducer Cover Item ID: SH22
FDA Device · Class II · 2021-06-30 · Exact Medical Manufacturing - reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment
FDA Device · Class II · 2021-06-30 · Pear Therapeutics - Medical Action INDUSTRIES INC., Disposable Instrument Pack Mosquito Hemostat, REF 56220
FDA Device · Class II · 2021-06-30 · Medical Action Industries 306 - Hays Innovation Ultrasound Probe Cover Kit - Ultrasonic Transducer Cover Item ID: HS2000HL
FDA Device · Class II · 2021-06-30 · Exact Medical Manufacturing - Medical Action INDUSTRIES INC., General Purpose Instrument Tray, REF 61209
FDA Device · Class II · 2021-06-30 · Medical Action Industries 306 - FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084
FDA Device · Class II · 2021-06-30 · Cardinal Health - Medical Action INDUSTRIES INC., Minor Procedure Tray, REF 61214
FDA Device · Class II · 2021-06-30 · Medical Action Industries 306 - OPTICHAMBER DIAMOND SPACER WITH LARGE MASK Item Number: 4742326
FDA Device · Class II · 2021-06-30 · Cardinal Health
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