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.
- PHOROPTOR VRX DIGITAL REFRACTION SYSTEM-Digital refractor intended for the subjective measurement of the refractive error of the eye
FDA Device · Class II · 2023-09-06 · Reichert - Olympus Bronchovideoscope, Models BF-MP190F
FDA Device · Class II · 2023-09-06 · Olympus - Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a knee prosthesis implant during a total k…
FDA Device · Class II · 2023-09-06 · Waldemar Link And Kg Mfg Site - Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-…
FDA Device · Class I · 2023-09-06 · Datascope - Olympus Bronchovideoscope, Models BF-XT190
FDA Device · Class II · 2023-09-06 · Olympus - Olympus Bronchovideoscope, Models BF-UC180F & BF-UC190F
FDA Device · Class II · 2023-09-06 · Olympus - Atellica CH Total Protein II- In vitro diagnostic use in the quantitative determination of total protein in human serum and plasma (lithium…
FDA Device · Class II · 2023-09-06 · Siemens Healthcare Diagnostics - GS70H Salus Surgical Table, Product Code 18-071-70
FDA Device · Class II · 2023-09-06 · Skytron - Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-…
FDA Device · Class I · 2023-09-06 · Datascope - Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
FDA Device · Class I · 2023-09-06 · Datascope - EMBLEM MRI S-ICD Pulse Generator Model A219
FDA Device · Class II · 2023-08-30 · Boston Scientific - Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300100414, 300100415, 300100418, 300100451, 300100452, 300100453,…
FDA Device · Class II · 2023-08-30 · Icu Medical - IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d) B15130613S, e) B15130615S, f) B15900806, g) B15900906, h) B1590100…
FDA Device · Class II · 2023-08-30 · Medicrea International - PASS LP, REF numbers: a) B02315535Z, b) B02315540Z, c) B02315545Z, d) B02315550Z, e) B02316535Z, f) B02316540Z, g) B02316545Z, h) B02316550…
FDA Device · Class II · 2023-08-30 · Medicrea International - The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighing…
FDA Device · Class II · 2023-08-30 · Medtronic Navigation Littleton - IMPIX ALIF S/A, REF number B15241415
FDA Device · Class II · 2023-08-30 · Medicrea International - IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412
FDA Device · Class II · 2023-08-30 · Medicrea International - BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only
FDA Device · Class II · 2023-08-30 · Biofire Diagnostics - TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail
FDA Device · Class II · 2023-08-30 · Smith And Nephew - The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC GASTROVIDEOSCOPE, ULTRASONIC CO…
FDA Device · Class II · 2023-08-30 · Olympus - ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151, in vitro diagnostic use in the quantitative determina…
FDA Device · Class II · 2023-08-30 · Siemens Healthcare Diagnostics - Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Complement C3, Complement C4, C…
FDA Device · Class II · 2023-08-30 · Randox Laboratories - IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B20240107, e) B20240205, f) B20240206, g) B20240207, h) B20240208
FDA Device · Class II · 2023-08-30 · Medicrea International - Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in the quality control of Amylase, Calcium, Chloride, Cortisol,…
FDA Device · Class II · 2023-08-30 · Randox Laboratories - EMBLEM S-ICD Pulse Generator Model A209
FDA Device · Class II · 2023-08-30 · Boston Scientific - DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also serve as a resting seat
FDA Device · Class II · 2023-08-30 · Invacare - IMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10122810, d) B242C11062810, e) B242C11122810, f) B242C12062810, g) B242C…
FDA Device · Class II · 2023-08-30 · Medicrea International - GRANVIA-C, REF numbers: a)¿¿¿¿¿ A13111427, b)¿¿¿¿ A13112567, c)¿¿¿¿¿ A13113456, d)¿¿¿¿ A13131516, e)¿¿¿¿ A13131789, f)¿¿¿¿¿¿ A13132012, g)¿…
FDA Device · Class II · 2023-08-30 · Medicrea International - IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B15334074S
FDA Device · Class II · 2023-08-30 · Medicrea International - Carina Sub-Acute Care Ventilator
FDA Device · Class I · 2023-08-30 · Draeger Medical - TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340, Femur nail
FDA Device · Class II · 2023-08-30 · Smith And Nephew - IMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, d) B20181743, e) B20181753, f) B20181763, g) B20181773, h) B20181943, i…
FDA Device · Class II · 2023-08-30 · Medicrea International - IMPIX DLIF, REF numbers: a) B16123509, b) B16123511, c) B16124009, d) B16124013, e) B16124509, f) B16124511, g) B16124513, h) B16164009, i)…
FDA Device · Class II · 2023-08-30 · Medicrea International - FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only
FDA Device · Class II · 2023-08-30 · Biofire Diagnostics - IMPIX MANTA+, REF numbers: a) B20171743, b) B20171753, c) B20171763, d) B20171773, e) B20171943, f) B20171953, g) B20171963, h) B20171973,…
FDA Device · Class II · 2023-08-30 · Medicrea International - MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, PASS Tray REF: 8888103002HP
FDA Device · Class I · 2023-08-23 · Covidien - UroPass Ureteral Access Sheaths, 5 pieces/box
FDA Device · Class II · 2023-08-23 · Olympus - MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit" REF: 8888345629
FDA Device · Class I · 2023-08-23 · Covidien - MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions REF: 8888345520HP
FDA Device · Class I · 2023-08-23 · Covidien - MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 8888102004HP
FDA Device · Class I · 2023-08-23 · Covidien - MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit REF: 8888345603HP
FDA Device · Class I · 2023-08-23 · Covidien - MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF: 8888345637
FDA Device · Class I · 2023-08-23 · Covidien - Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 50 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7045
FDA Device · Class II · 2023-08-23 · Carefusion 2200 - Snowden-Pencer MIS DIAMOND-TOUCH GRASPER DIAMOND JAW BABCOCK 5MM, 32CM, RATCHETED, REF SP90-7018
FDA Device · Class II · 2023-08-23 · Carefusion 2200 - Legion FMS Pak
FDA Device · Class II · 2023-08-23 · Alcon Research - MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit REF: 8888345611HP
FDA Device · Class I · 2023-08-23 · Covidien - Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAMOND JAW 5MM, 45CM, RATCHETED, REF SP90-7271
FDA Device · Class II · 2023-08-23 · Carefusion 2200 - Phaco Standalone Tips
FDA Device · Class II · 2023-08-23 · Alcon Research - MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, PASS Tray REF: 8888104003HP
FDA Device · Class I · 2023-08-23 · Covidien - Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM, 45CM, RATCHETED HANDLE, REF SP90-7266
FDA Device · Class II · 2023-08-23 · Carefusion 2200 - Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 60 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7046
FDA Device · Class II · 2023-08-23 · Carefusion 2200 - MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit REF: 8888345629HP
FDA Device · Class I · 2023-08-23 · Covidien - FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System
FDA Device · Class II · 2023-08-23 · Abbott Diabetes Care - Snowden-Pencer MIS DIAMOND-TOUCH GRASPER CRILE CURVED JAW 5MM, 32CM, RATCHETED, REF SP90-7048
FDA Device · Class II · 2023-08-23 · Carefusion 2200 - Centurion FMS Pak
FDA Device · Class II · 2023-08-23 · Alcon Research - Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular Catheter, STERILE EO, Rx Only
FDA Device · Class II · 2023-08-23 · Medtronic Neurosurgery - Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAMOND JAW 5MM, 32CM, RATCHETED, REF SP90-7071
FDA Device · Class II · 2023-08-23 · Carefusion 2200 - MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629
FDA Device · Class I · 2023-08-23 · Covidien - Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM, 45CM, RATCHETED, REF SP90-7220
FDA Device · Class II · 2023-08-23 · Carefusion 2200 - MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, IC Tray REF: 8888101003HP
FDA Device · Class I · 2023-08-23 · Covidien - Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM, 32CM, RATCHETED, REF SP90-7020
FDA Device · Class II · 2023-08-23 · Carefusion 2200 - Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR FENESTRATED 16MM JAW 5MM, 32CM, NON RATCHETED, REF SP90-7036
FDA Device · Class II · 2023-08-23 · Carefusion 2200 - CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO
FDA Device · Class II · 2023-08-23 · Conformis - MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit" REF: 8888345611
FDA Device · Class I · 2023-08-23 · Covidien - MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, IC Tray REF:8888101001HP
FDA Device · Class I · 2023-08-23 · Covidien - MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit" REF: 8888345603
FDA Device · Class I · 2023-08-23 · Covidien - Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 25 MM JAW 5MM, 45CM, RATCHETED, REF SP90-7243
FDA Device · Class II · 2023-08-23 · Carefusion 2200 - MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions REF: 8888345512HP
FDA Device · Class I · 2023-08-23 · Covidien - Snowden-Pencer MIS DIAMOND-TOUCH GRASPER MCKERNAN FUNDUS 5MM, 32CM, RATCHETED, REF SP90-7012
FDA Device · Class II · 2023-08-23 · Carefusion 2200 - MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, IC Tray REF: 8888101004HP
FDA Device · Class I · 2023-08-23 · Covidien - MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629HP
FDA Device · Class I · 2023-08-23 · Covidien - MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, PASS Tray REF: 8888104004HP
FDA Device · Class I · 2023-08-23 · Covidien - HF Resection Electrodes - HF resection electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in urological or…
FDA Device · Class II · 2023-08-23 · Olympus - MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, PASS Tray REF: 8888103004HP
FDA Device · Class I · 2023-08-23 · Covidien - MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, PASS Tray REF: 8888103001HP
FDA Device · Class I · 2023-08-23 · Covidien - Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 35 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7044
FDA Device · Class II · 2023-08-23 · Carefusion 2200 - Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM, 32CM, RATCHETED HANDLE, REF SP90-7066
FDA Device · Class II · 2023-08-23 · Carefusion 2200 - MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, IC Tray REF: 8888101002HP
FDA Device · Class I · 2023-08-23 · Covidien - MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF: 8888345637HP
FDA Device · Class I · 2023-08-23 · Covidien - Infinity FMS Pak
FDA Device · Class II · 2023-08-23 · Alcon Research - Constellation Procedure Pak
FDA Device · Class II · 2023-08-23 · Alcon Research - Alcon Custom Pak
FDA Device · Class II · 2023-08-23 · Alcon Research - MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, IC Tray REF: 8888102003HP
FDA Device · Class I · 2023-08-23 · Covidien - MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, Kit REF: 8888340637
FDA Device · Class I · 2023-08-23 · Covidien - MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, Kit REF: 8888340637HP
FDA Device · Class I · 2023-08-23 · Covidien - Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 25 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7043
FDA Device · Class II · 2023-08-23 · Carefusion 2200 - VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V- For airway management which includes endoscopic observation to access airway anato…
FDA Device · Class II · 2023-08-16 · Olympus - LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 16 - Indicated for patients with Mobility-limiting diseases, fractures or defects…
FDA Device · Class II · 2023-08-16 · Waldemar Link And Kg Mfg Site - UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift¿ system
FDA Device · Class II · 2023-08-16 · Scholly Fiberoptic - ellacor System with Micro-Coring Technology-Indicated for use by medical professionals for the treatment of moderate and severe wrinkles in…
FDA Device · Class II · 2023-08-16 · Cytrellis Biosystems - LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 24 - Indicated for patients with Mobility-limiting diseases, fractures or defects…
FDA Device · Class II · 2023-08-16 · Waldemar Link And Kg Mfg Site - LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 25 - Indicated for patients with Mobility-limiting diseases, fractures or defects…
FDA Device · Class II · 2023-08-16 · Waldemar Link And Kg Mfg Site - INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLE
FDA Device · Class II · 2023-08-16 · Canon Medical System Usa - Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106
FDA Device · Class II · 2023-08-16 · Philips North America - LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 14-Indicated for patients with Mobility-limiting diseases, fractures or defects of…
FDA Device · Class II · 2023-08-16 · Waldemar Link And Kg Mfg Site - ARTIS icono biplane -Angiography systems developed for single and biplane diagnostic imaging and interventional procedures
FDA Device · Class II · 2023-08-16 · Siemens Medical Solutions Usa - Olympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and t…
FDA Device · Class II · 2023-08-16 · Olympus - Olympus Endoscope Reprocessor OER-Mini-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and th…
FDA Device · Class II · 2023-08-16 · Olympus - Medtronic InterStim Ground Pad REF 041826
FDA Device · Class II · 2023-08-16 · Medtronic Neuromodulation - LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 22 - Indicated for patients with Mobility-limiting diseases, fractures or defects…
FDA Device · Class II · 2023-08-16 · Waldemar Link And Kg Mfg Site
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)