FDA Device · 2024

FDA Device recalls in 2024

RecallRadar indexes 3,393 FDA Device recall notices published in 2024. By classification: 392 Class I, 2,970 Class II, 31 Class III.

• Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of medical image data sets…
  FDA Device · Class II · 2024-02-28 · Ptw Freiburg
• Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, f) 2122
  FDA Device · Class II · 2024-02-28 · Voco
• 3M Specialty Blade Assembly, REF 9660,70-2011-8491-1, 7100213026, used with used with 3M Surgical Clipper Catalog Number 9661L
  FDA Device · Class II · 2024-02-28 · 3m Health Care Business
• HENRY SCHEIN¿ CRITERION¿ ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-3281)
  FDA Device · Class II · 2024-02-28 · Amd Medicom
• EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510
  FDA Device · Class II · 2024-02-28 · Boston Scientific
• Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Mod…
  FDA Device · Class II · 2024-02-28 · Philips Medical Systems Nederland B V
• TRACH KIT W/HYDROGEN & SALI
  FDA Device · Class I · 2024-02-28 · Cardinal Health 200
• Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system
  FDA Device · Class II · 2024-02-28 · Philips Medical Systems Nederland B V
• Baxter Exactamix Pro 2400, REF EXM24DY
  FDA Device · Class I · 2024-02-28 · Baxter Healthcare
• Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO
  FDA Device · Class I · 2024-02-28 · Windstone Medical Packaging
• Epidural tray
  FDA Device · Class II · 2024-02-28 · B Braun Medical
• Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline 18 Fr/Ch (6.0mm)
  FDA Device · Class I · 2024-02-28 · Cardinal Health 200
• Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, NEEDLE PORT, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG
  FDA Device · Class I · 2024-02-28 · Cardinal Health 200
• ESG PK CUTTING FORCEPS, 5MM, 33CM
  FDA Device · Class II · 2024-02-28 · Olympus
• IonoStar Plus, Catalog (REF) Numbers: a) 2540, b)2543, c) 2544, d) 2545, e) 2546, f) 2547, g) 2549
  FDA Device · Class II · 2024-02-28 · Voco
• AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe, USP, 5mL in 12mL, REF 2T0805
  FDA Device · Class II · 2024-02-28 · Mrp
• The INFX-8000F is designed to take advantage of the latest technological innovations to reduce dose and to save time
  FDA Device · Class II · 2024-02-28 · Canon Medical System Usa
• Dover" IRRIGATION 1200 CC TRAY, 60 CC PISTON SYRINGE, STERILE SALINE, TIP PROTECTOR, ALCOHOL, LIDDED
  FDA Device · Class I · 2024-02-28 · Cardinal Health 200
• Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Mode…
  FDA Device · Class II · 2024-02-28 · Philips Medical Systems Nederland B V
• Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEO
  FDA Device · Class I · 2024-02-28 · Windstone Medical Packaging
• Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems
  FDA Device · Class II · 2024-02-28 · Philips Medical Systems Nederland B V
• The device is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting
  FDA Device · Class II · 2024-02-28 · Canon Medical System Usa
• 3M Specialty Blade Assembly, REF 9660,70-2011-8462-2, 7100213114, used with used with 3M Surgical Clipper Catalog Number 9661L
  FDA Device · Class II · 2024-02-28 · 3m Health Care Business
• PATTERSON¿ PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573)
  FDA Device · Class II · 2024-02-28 · Amd Medicom
• Dover" 100% SILICONE FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT
  FDA Device · Class I · 2024-02-28 · Cardinal Health 200
• Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG
  FDA Device · Class I · 2024-02-28 · Cardinal Health 200
• These wipes are saturated with 0.65% bleach solution
  FDA Device · Class II · 2024-02-28 · Medline Industries Northfield
• W&H Surgical handpiece S-12
  FDA Device · Class II · 2024-02-28 · W And H Dentalwerk Buermoos
• Baxter Exactamix Pro 1200, REF EXM12DY
  FDA Device · Class I · 2024-02-28 · Baxter Healthcare
• GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus 3000, e) Care Plus 4000, Plus 40…
  FDA Device · Class I · 2024-02-21 · Wipro Ge Healthcare Private
• ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref:706150
  FDA Device · Class II · 2024-02-21 · Philips North America
• Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184
  FDA Device · Class II · 2024-02-21 · Microbiologics
• Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.…
  FDA Device · Class I · 2024-02-21 · Abiomed
• Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077
  FDA Device · Class II · 2024-02-21 · Maquet Medical Systems Usa
• CombiDiagnost R90 1.1 (709031)
  FDA Device · Class II · 2024-02-21 · Philips Medical Systems
• GE Healthcare neonatal incubator, models: a) Lullaby Incubator, b) Lullaby Incubator XP, c) Lullaby Incubator TR
  FDA Device · Class I · 2024-02-21 · Wipro Ge Healthcare Private
• Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscop…
  FDA Device · Class II · 2024-02-21 · Olympus
• Samsung Digital Diagnostic Mobile X-ray System, Model GM85
  FDA Device · Class II · 2024-02-21 · Neurologica
• Stryker Neurovascular, Trevo Pro 18 Microcatheter, REF 90238 0.021in X150cm
  FDA Device · Class II · 2024-02-21 · Stryker
• Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.…
  FDA Device · Class II · 2024-02-21 · Abiomed
• Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm
  FDA Device · Class II · 2024-02-21 · Stryker
• GE Healthcare Care Plus Hood Field Replacement Unit (FRU) kit, Part Numbers: 6600-0047-851, 6600-0033-850, 6600-0081-850, 6600-0961-500, 66…
  FDA Device · Class I · 2024-02-21 · Wipro Ge Healthcare Private
• GE Healthcare Care Plus Hood Door FRU kit, Part Numbers: 6600-0082-850, 6600-0504-800, 6600-0148-800, and 6600-0970-500
  FDA Device · Class I · 2024-02-21 · Wipro Ge Healthcare Private
• CombiDiagnost R90 1.0 (709030)
  FDA Device · Class II · 2024-02-21 · Philips Medical Systems
• BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078
  FDA Device · Class II · 2024-02-21 · Maquet Medical Systems Usa
• GE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169767, M1160674, M1187512, M1206646, M1166822
  FDA Device · Class I · 2024-02-21 · Wipro Ge Healthcare Private
• 3:1 Dermacarrier, Model Number 00219501300, skin graft carrier
  FDA Device · Class II · 2024-02-21 · Zimmer Surgical
• AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (bone void filler)
  FDA Device · Class II · 2024-02-21 · Musculoskeletal Transplant Foundation
• BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic medium BD BACTEC Peds Plus medium BD BACTEC…
  FDA Device · Class II · 2024-02-21 · Biofire Diagnostics
• HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P/350-UNIT-US-10, 350-STR-US-10, 350-STR-UK-10
  FDA Device · Class II · 2024-02-21 · Heartsine Technologies
• MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007
  FDA Device · Class II · 2024-02-21 · Sedecal
• ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref: (1)706100 (2)706110
  FDA Device · Class II · 2024-02-21 · Philips North America
• GE Healthcare Lullaby Incubator Model Hood FRU kit, Part Numbers: M1169566, M1160659, M1206259, M1206260, M1166836, M1166814
  FDA Device · Class I · 2024-02-21 · Wipro Ge Healthcare Private
• global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle)
  FDA Device · Class II · 2024-02-21 · Coopersurgical
• Captus 4000e Thyroid Uptake Systems- Intended to be used by trained Nuclear Medicine Technologists or Nuclear Medicine Physicians to perfor…
  FDA Device · Class II · 2024-02-21 · Mirion Technologies Capintec
• FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal microorganism multiplex nucle…
  FDA Device · Class II · 2024-02-21 · Biofire Diagnostics
• The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with Sofia 2 to detect nucleocap…
  FDA Device · Class II · 2024-02-21 · Quidel
• AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler)
  FDA Device · Class II · 2024-02-21 · Musculoskeletal Transplant Foundation
• Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD tubing, REF: RF-T15, and 60ml syringe on a female luer with 15…
  FDA Device · Class II · 2024-02-21 · Origen Biomedical
• Cardinal Health Monoject, 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, REF 1180100777
  FDA Device · Class I · 2024-02-14 · Cardinal Health 200
• Cardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 435SE
  FDA Device · Class I · 2024-02-14 · Cardinal Health 200
• Ingenia Elition X (Product Number 781358) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system
  FDA Device · Class II · 2024-02-14 · Philips North America
• BD BBL Sensi Disc Ampicillin with Sulbactam 10/10 ¿g, Catalog Number 231660
  FDA Device · Class II · 2024-02-14 · Becton Dickinson And
• Barco MDSC-8527 NXF, Part Number K9352421
  FDA Device · Class II · 2024-02-14 · Barco N V
• Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
  FDA Device · Class II · 2024-02-14 · Siemens Healthcare Diagnostics
• Cardinal Health Monoject, 3 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 403SE
  FDA Device · Class I · 2024-02-14 · Cardinal Health 200
• Senographe Pristina
  FDA Device · Class II · 2024-02-14 · Ge Medical Systems Scs
• Bubble Sensor (REF: 70105.5720)
  FDA Device · Class II · 2024-02-14 · Maquet Medical Systems Usa
• Dual Articulating Headrest, Velcro P/N P141210813, REF BF753
  FDA Device · Class II · 2024-02-14 · Steris
• Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410
  FDA Device · Class II · 2024-02-14 · Beckman Coulter
• Guardian 4 Glucose Sensor, REF: MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3, MMT-7040D1, MMT-7040D2, MMT-7040MA, MMT-7040QC1, MMT-7040QC2…
  FDA Device · Class II · 2024-02-14 · Medtronic Minimed
• Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref: 61…
  FDA Device · Class II · 2024-02-14 · Globus Medical
• Flow-i C30 Anesthesia System, model 6677300
  FDA Device · Class II · 2024-02-14 · Getinge Usa Sales
• Flow-i C40 Anesthesia System, model 6677400
  FDA Device · Class II · 2024-02-14 · Getinge Usa Sales
• Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems
  FDA Device · Class II · 2024-02-14 · Coopersurgical
• Dual Articulating Headrest, Pad Ret P/N P141210805, REF BF754
  FDA Device · Class II · 2024-02-14 · Steris
• BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 701047553
  FDA Device · Class II · 2024-02-14 · Maquet Medical Systems Usa
• Cardinal Health Monoject, 12 mL Syringe Luer-Lock Tip Soft Pack, REF 1181200777T
  FDA Device · Class I · 2024-02-14 · Cardinal Health 200
• BD BBL Sensi Disc Sulfamethoxazole with Trimethoprim 23.75/1.25 ug, used for semi-quantitative in vitro susceptibility testing
  FDA Device · Class II · 2024-02-14 · Becton Dickinson And
• BD BBL Sensi Disc Ofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing
  FDA Device · Class II · 2024-02-14 · Becton Dickinson And
• BD BBL Sensi Disc Ampicillin - 10 ¿g, Catalog No. 230705 and 231264
  FDA Device · Class II · 2024-02-14 · Becton Dickinson And
• Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and placement of cranial devices with the ExcelsiusGP…
  FDA Device · Class II · 2024-02-14 · Globus Medical
• BrightView, gamma camera system
  FDA Device · Class I · 2024-02-14 · Philips North America
• BD BBL Sensi Disc Azithromycin -15 ¿g, Catalog Number 231682¿used for semi-quantitative in vitro susceptibility testing
  FDA Device · Class II · 2024-02-14 · Becton Dickinson And
• Sensi Disc Amoxicillin with Clavulanic Acid 20/10 ¿g, Catalog No. 231628 and 231629.¿ These discs are used for semi-quantitative in vitro s…
  FDA Device · Class II · 2024-02-14 · Becton Dickinson And
• BD BBL Sensi Disc Minocycline - 30 ug, used for semi-quantitative in vitro susceptibility testing
  FDA Device · Class II · 2024-02-14 · Becton Dickinson And
• Spectral CT on Rails: Software Version 5.1.0.X, model 728334
  FDA Device · Class II · 2024-02-14 · Philips Medical Systems
• FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56
  FDA Device · Class II · 2024-02-14 · G And H Wire
• BD BBL Sensi Disc Augmentin - 3¿g, Catalog Number 291270¿used for semi-quantitative in vitro susceptibility testing
  FDA Device · Class II · 2024-02-14 · Becton Dickinson And
• Cardinal Health Monoject, 12mL Enteral Syringe (purple) For Use with ENFit Connection System, REF 412SE
  FDA Device · Class I · 2024-02-14 · Cardinal Health 200
• Water Filter MAJ-2318
  FDA Device · Class II · 2024-02-14 · Olympus
• BD BBL Sensi Disc Moxifloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing
  FDA Device · Class II · 2024-02-14 · Becton Dickinson And
• Sperm separation media are used to separate motile sperm from other constituents of semen
  FDA Device · Class II · 2024-02-14 · Fujifilm Irvine Scientific
• Cardinal Health Monoject, 20 mL Syringe Luer-Lock Tip Soft Pack, REF 1182000777
  FDA Device · Class I · 2024-02-14 · Cardinal Health 200
• BrightView XCT, gamma camera for SPECT
  FDA Device · Class I · 2024-02-14 · Philips North America
• FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit)
  FDA Device · Class II · 2024-02-14 · Biofire Diagnostics
• AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for fixation of prosthetic material to soft tissue in min…
  FDA Device · Class II · 2024-02-14 · Covidien
• RX Series Copper (Cu) Assay Ref
  FDA Device · Class II · 2024-02-14 · Randox Laboratories
• BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 701047554
  FDA Device · Class II · 2024-02-14 · Maquet Medical Systems Usa
• HRIS ACET CUP CUT TIP 32X140 Part Number: 6210-5-200rker. single-use, sterile surgical instruments used during hip arthroplasty
  FDA Device · Class II · 2024-02-14 · Howmedica Osteonics

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)