FDA Device · 2023
FDA Device recalls in 2023
RecallRadar indexes 2,477 FDA Device recall notices published in 2023. By classification: 495 Class I, 1,959 Class II, 23 Class III.
- CS¿9600¿is¿an¿extraoral¿system¿intended¿to¿produce¿two-dimensional¿and¿three-dimensional¿digital¿X-ray¿images¿of¿the¿dento-maxilofacial,¿EN…
FDA Device · Class II · 2023-06-07 · Trophy Sas - Intelli-C, Right side suspended Tabletop, REF: 03400000
FDA Device · Class II · 2023-06-07 · Nrt X Ray A S - BEQ-HMO 71000-USA /QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067829
FDA Device · Class II · 2023-06-07 · Maquet Medical Systems Usa - QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 10000-USA 701070412 HMO 11000-USA 701070416
FDA Device · Class II · 2023-06-07 · Maquet Medical Systems Usa - VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Data Release Versions…
FDA Device · Class II · 2023-06-07 · Ortho Clinical Diagnostics - HMOD 70000-USA/QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067840
FDA Device · Class II · 2023-06-07 · Maquet Medical Systems Usa - Teleflex HORIZON Microclip Titanium Ligating Clips w/tape, REF 005200
FDA Device · Class II · 2023-06-07 · Teleflex - Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 701070445
FDA Device · Class II · 2023-06-07 · Maquet Medical Systems Usa - Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part Numbers: a) REF 1-10011-100 (SIZE 1-2), b) REF 1-10011-200 (SI…
FDA Device · Class II · 2023-06-07 · Smith And Nephew - QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 701070388
FDA Device · Class II · 2023-06-07 · Maquet Medical Systems Usa - Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Insert, Part Numbers: a) REF 1-10013-109, SIZE 1-LEFT MED, 9MM
FDA Device · Class II · 2023-06-07 · Smith And Nephew - QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-USA 701067936 Small Adult with filter, with BIOLINE…
FDA Device · Class II · 2023-06-07 · Maquet Medical Systems Usa - Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Tray, Part Numbers: a) REF 1-10012-100, SIZE 1-LEFT MEDIAL
FDA Device · Class II · 2023-06-07 · Smith And Nephew - BEQ-HMO 50000-USA/ QUADROX-i Small, Oxygenator used during cardiopulmonary bypass Item no. 701067905
FDA Device · Class II · 2023-06-07 · Maquet Medical Systems Usa - TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog Number: 5531-G-312-E
FDA Device · Class II · 2023-06-07 · Howmedica Osteonics - Intelli-C, Left side suspended Tabletop, REF: 03400010
FDA Device · Class II · 2023-06-07 · Nrt X Ray A S - Cytrellis ellacor System with Micro-Coring Technology-Dermal Micro-Coring System System intended for the treatment of moderate and severe w…
FDA Device · Class II · 2023-06-07 · Cytrellis Biosystems - Procedure packs: (1) Medline Sterile Arthroscopy Pack, REF: DYNJ64242B
FDA Device · Class II · 2023-06-07 · Medline Industries Northfield - Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity
FDA Device · Class II · 2023-06-07 · Elekta - BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass Item no. 701067859
FDA Device · Class II · 2023-06-07 · Maquet Medical Systems Usa - Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6. Models/Model Number: (1) Azurion 3M12: 722063, 72…
FDA Device · Class II · 2023-06-07 · Philips Medical Systems Nederland B V - QUADROX-iD Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. BEQ-HMOD30000-USA 701070397 BEQ-HMOD30000-USA 701050330
FDA Device · Class II · 2023-06-07 · Maquet Medical Systems Usa - TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement Catalog Number: 5532-G-413-E
FDA Device · Class II · 2023-06-07 · Howmedica Osteonics - QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 70000-USA 701067820 HMO 71000-USA 701067823 BEQ-HMO 71000…
FDA Device · Class II · 2023-06-07 · Maquet Medical Systems Usa - Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 701070445
FDA Device · Class II · 2023-06-07 · Maquet Medical Systems Usa - QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 701070388
FDA Device · Class II · 2023-06-07 · Maquet Medical Systems Usa - Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components, Part Numbers: a) REF 1-10003-100 (SIZE 1 Right Medial)
FDA Device · Class II · 2023-06-07 · Smith And Nephew - EarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01 Product Number: 863380
FDA Device · Class II · 2023-06-07 · Philips North America - QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no
FDA Device · Class II · 2023-06-07 · Maquet Medical Systems Usa - LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan, cemented
FDA Device · Class II · 2023-06-07 · Linkbio - Aligned Medical Solutions Minor Hand Pack, REF: AMS6539E, containing P 2 Cover Light Handle Blue STE, Sterile EO
FDA Device · Class II · 2023-05-31 · Windstone Medical Packaging - ADVIA Chemistry ToxAmmonia Calibrator- In vitro diagnostic use in the calibration of ethanol (ETOH_2), ammonia (AMM), acetaminophen (ACET),…
FDA Device · Class II · 2023-05-31 · Siemens Healthcare Diagnostics - Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: 728144
FDA Device · Class II · 2023-05-31 · Philips Headquarters Cambridge - Luminos dRF Max (VE10, VF10, VF11)
FDA Device · Class II · 2023-05-31 · Siemens Medical Solutions Usa - Luminos Agile Max (VE10, VF10, VF11)
FDA Device · Class II · 2023-05-31 · Siemens Medical Solutions Usa - Codman Cranial Hand Drill- Indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or…
FDA Device · Class II · 2023-05-31 · Integra Lifesciences - Aligned Medical Solutions Spine Pack, REF: AMS4599(C, containing P 2 Cover Light Handle Blue STE, Sterile EO
FDA Device · Class II · 2023-05-31 · Windstone Medical Packaging - Incisive CT Power- Whole-body computed tomography (CT) X-Ray System Model Number: 728148 (OUS)
FDA Device · Class II · 2023-05-31 · Philips Headquarters Cambridge - ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of s…
FDA Device · Class III · 2023-05-31 · Olympus - Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light Handle Blue STE, Sterile EO
FDA Device · Class II · 2023-05-31 · Windstone Medical Packaging - LUMINOS Lotus Max (VF11)
FDA Device · Class II · 2023-05-31 · Siemens Medical Solutions Usa - Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System Model Number: 728149 (OUS)
FDA Device · Class II · 2023-05-31 · Philips Headquarters Cambridge - EXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001 (10 ml blood pump)
FDA Device · Class I · 2023-05-31 · Berlin Heart - binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae Ref: 1.002.101
FDA Device · Class II · 2023-05-31 · Binx Health - To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the trache…
FDA Device · Class III · 2023-05-31 · Olympus - Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes Model Number: 298921373
FDA Device · Class II · 2023-05-31 · Omnicell - Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA III Duodenovideoscope TJF-Q190V
FDA Device · Class II · 2023-05-31 · Olympus - VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated hemoglobin A1c (DCCT/NGSP) and mmol…
FDA Device · Class II · 2023-05-31 · Ortho Clinical Diagnostics - Atellica CH Toxicology Calibrator (TOX CAL)-The Atellica¿ CH Toxicology Calibrator (TOX CAL) is for in vitro diagnostic use in calibrating…
FDA Device · Class II · 2023-05-31 · Siemens Healthcare Diagnostics - Arjo Portable Scale Adaptor, Model Number 700.05725
FDA Device · Class II · 2023-05-31 · Arjohuntleigh Magog - Incisive CT- Whole-body computed tomography (CT) X-Ray System Model Number: 728143 (OUS)
FDA Device · Class II · 2023-05-31 · Philips Headquarters Cambridge - Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728)
FDA Device · Class I · 2023-05-31 · Sd Biosensor - ASM Replacement Battery, Component Number SUB0000864
FDA Device · Class I · 2023-05-24 · Icu Medical - VentStar Basic (P)180, MP00351
FDA Device · Class I · 2023-05-24 · Draeger Medical - Replacement Battery List Number SUB0000594 found in Plum A+ & Plum A+3 Infusion Systems, List Numbers: a) 11005, b) 11971, c) 12391, d) 126…
FDA Device · Class I · 2023-05-24 · Icu Medical - ID Coax 180, MP03375
FDA Device · Class I · 2023-05-24 · Draeger Medical - Vapor-Clean, Part Number 111AU The Vapor-Clean filter is intended to be used to remove unwanted anesthetic gases from the patient breathing…
FDA Device · Class II · 2023-05-24 · Dynasthetics - YelloPort Elite, REF: EO0507005, 5x70 Optical Trocar, , Rx Only, SterileR
FDA Device · Class II · 2023-05-24 · Surgical Innovations - WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package)
FDA Device · Class II · 2023-05-24 · Boston Scientific - Seattle PAP Plus, MP02260
FDA Device · Class I · 2023-05-24 · Draeger Medical - ID Circuit Basic (P) 180, MP01340
FDA Device · Class I · 2023-05-24 · Draeger Medical - CombiDiagnost R90 R.1.0
FDA Device · Class II · 2023-05-24 · Philips North America - REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,<12", Rx Only Non-Sterile
FDA Device · Class II · 2023-05-24 · Stryker Sustainability Solutions - YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR
FDA Device · Class II · 2023-05-24 · Surgical Innovations - ProxiDiagnost N90 R.1.0
FDA Device · Class II · 2023-05-24 · Philips North America - Spectral CT 7500 Computed Tomography X-Ray System, Model Number 728333
FDA Device · Class II · 2023-05-24 · Philips North America - VentStar Basic (N) 180, MP00353
FDA Device · Class I · 2023-05-24 · Draeger Medical - Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010
FDA Device · Class I · 2023-05-24 · Icu Medical - VentStar Watertrap (N) 180, MP00363
FDA Device · Class I · 2023-05-24 · Draeger Medical - Immundiagnostik IDK Lactoferrin ELISA- In vitro enzyme immunoassay intended for the determination of lactoferrin in stool
FDA Device · Class II · 2023-05-24 · Immundiagnostik - Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72813
FDA Device · Class II · 2023-05-24 · Philips North America - DuraLife Autoclavable Silicone Extension Tube, REF 60-1502 (UltraSet Product Code 66-2509)
FDA Device · Class II · 2023-05-24 · Smiths Medical Asd - Set2Go Ventilation 12 (A), MP07968
FDA Device · Class I · 2023-05-24 · Draeger Medical - Anesthesia Circuit Kit Coax HEPA, MP17102
FDA Device · Class I · 2023-05-24 · Draeger Medical - Anesthesia Circuit Kit Coax 1, MP02730
FDA Device · Class I · 2023-05-24 · Draeger Medical - Teleflex (manufacturer: Vascular SOLUTIONS) D-Stat Flowable Hemostat, REF 4000
FDA Device · Class II · 2023-05-24 · Teleflex - Anesthesia Circuit Kit Coax 3, MP02732
FDA Device · Class I · 2023-05-24 · Draeger Medical - VentStar Anesthesia WT (P)180, MP00374
FDA Device · Class I · 2023-05-24 · Draeger Medical - VentStar breathing bag Set (P) 110, MP00384
FDA Device · Class I · 2023-05-24 · Draeger Medical - VentStar Anesthesia (N) 180, MP00333
FDA Device · Class I · 2023-05-24 · Draeger Medical - HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004
FDA Device · Class II · 2023-05-24 · Access Vascular - ASM Replacement Battery, Component Number SUB0000594
FDA Device · Class I · 2023-05-24 · Icu Medical - DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991)
FDA Device · Class II · 2023-05-24 · Smiths Medical Asd - VentStar Coax (P) 150, MP00379
FDA Device · Class I · 2023-05-24 · Draeger Medical - Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mL
FDA Device · Class II · 2023-05-24 · Beckman Coulter - Beckman Coulter Bicarbonate, REF: OSR6237, 4x50 mL
FDA Device · Class II · 2023-05-24 · Beckman Coulter - Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL
FDA Device · Class II · 2023-05-24 · Beckman Coulter - WATCHDOG ACCESSORY KIT (20-PACK), UPN H74939343A021 (outer package), UPN H74939343A020 (inner package)
FDA Device · Class II · 2023-05-24 · Boston Scientific - VentStar Watertrap (P) 180, MP00361
FDA Device · Class I · 2023-05-24 · Draeger Medical - Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72814
FDA Device · Class II · 2023-05-24 · Philips North America - ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant Catalog #: AET3R5010B
FDA Device · Class II · 2023-05-24 · Hiossen - DuraLife Autoclavable Silicone Extension Tube, REF 60-1510 (UltraSet Product Code 66-2505)
FDA Device · Class II · 2023-05-24 · Smiths Medical Asd - UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis
FDA Device · Class II · 2023-05-24 · Beckman Coulter - VentStar Watertrap (P) 180 w/oLL, MP00362
FDA Device · Class I · 2023-05-24 · Draeger Medical - Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062
FDA Device · Class II · 2023-05-24 · Steris - DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagnostic device, urine analysis
FDA Device · Class II · 2023-05-24 · Beckman Coulter - VentStar Basic (P)250, MP00352
FDA Device · Class I · 2023-05-24 · Draeger Medical - Ventstar Coax 230, MP03376
FDA Device · Class I · 2023-05-24 · Draeger Medical - Ventstar Coax, MP03373
FDA Device · Class I · 2023-05-24 · Draeger Medical - Anesthesia Set Coax 180, MP03384
FDA Device · Class I · 2023-05-24 · Draeger 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)