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.
- Arrow Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-45854-P1A
FDA Device · Class I · 2023-10-11 · Arrow International - Puritan Bennett Cuff Pressure Manager, REF: 180-03
FDA Device · Class II · 2023-10-11 · Covidien - Guider Softip Guide Catheter 6F 100CM MULTI PURPOSE, Catalog number M003101460, cardiac guide catheter
FDA Device · Class II · 2023-10-11 · Boston Scientific - Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet, REF CDC-45563-TTS
FDA Device · Class I · 2023-10-11 · Arrow International - Guider Softip Guide Catheter 5F 100CM MULTI PURPOSE, Catalog number M003101630, cardiac guide catheter
FDA Device · Class II · 2023-10-11 · Boston Scientific - IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during surgical procedures by the application of extreme…
FDA Device · Class II · 2023-10-11 · Icecure Medical - ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and 10341118 (7 x 145 tests)
FDA Device · Class II · 2023-10-11 · Siemens Healthcare Diagnostics - Zimmer Dermatome Blades- 10-pack boxes of blades
FDA Device · Class II · 2023-10-11 · Zimmer Surgical - therascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection of seven somatic mut…
FDA Device · Class II · 2023-10-11 · Qiagen - Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT
FDA Device · Class II · 2023-10-11 · Thoratec - Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators
FDA Device · Class II · 2023-10-11 · Medtronic Neuromodulation - REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO
FDA Device · Class II · 2023-10-11 · Becton Dickinson Infusion Therapy Systems - Guider Softip Guide Catheter 7F 90CM MULTI PURPOSE, Catalog number H965100470, cardiac guide catheter
FDA Device · Class II · 2023-10-11 · Boston Scientific - F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)
FDA Device · Class II · 2023-10-11 · Ge Medical Systems China - Guider Softip Guide Catheter 5F 90CM MULTI PURPOSE, Catalog number M003100630, cardiac guide catheter
FDA Device · Class II · 2023-10-11 · Boston Scientific - 3M Attest Super Rapid Readout Steam Challenge Pack, REF 1496V
FDA Device · Class II · 2023-10-04 · 3m Health Care Business - Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during diagnostic and operative hysteroscopies and to monit…
FDA Device · Class II · 2023-10-04 · Wom World - Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US) and 1137276 (Philippines)
FDA Device · Class I · 2023-10-04 · Philips Respironics - BD Pyxis MedBank MedPass Software, REF: 139088-01
FDA Device · Class II · 2023-10-04 · Carefusion 303 - Baxter Epiphany Cardio Server E3 ECG Management System Servers with software versions: a) v6.1.x, b) v6.2.x, c) v7.0.x
FDA Device · Class II · 2023-10-04 · Baxter Healthcare - B.Braun NORM-JECT Luer Lock Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to…
FDA Device · Class II · 2023-10-04 · B Braun Medical - ProSun International Luxura Vegaz, Model 52X
FDA Device · Class II · 2023-10-04 · J And T Health And Wellness - 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482V
FDA Device · Class II · 2023-10-04 · 3m Health Care Business - B. Braun NORM-JECT Luer Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/fro…
FDA Device · Class II · 2023-10-04 · B Braun Medical - 3M Attest Super Rapid Readout Biological Indicator, REF 1492V
FDA Device · Class II · 2023-10-04 · 3m Health Care Business - exoplan version 3.1 Rijeka Software -A medical software, intended to support the pre-operative planning of dental implants using the visual…
FDA Device · Class II · 2023-10-04 · Exocad - Henke-Ject-2 part luer sterile single use syringes - used for intravenous, intramuscular, subcutaneous, intracutaneous and intraarterial in…
FDA Device · Class II · 2023-10-04 · Wolf Henke Sass - Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm
FDA Device · Class II · 2023-10-04 · Covidien - Various Medical Products stored on pallets, including but not limited to bandages, tampons, condoms, blood glucose monitors, adult diapers,…
FDA Device · Class II · 2023-10-04 · Inmar Supply Chain Solutions - Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to display live imaging data from compatible Ambu visualization devices, portab…
FDA Device · Class II · 2023-10-04 · Ambu - Cinchlock SS Knotless Anchor Inserter, Part Number CAT02462
FDA Device · Class II · 2023-10-04 · Stryker - MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20 degrees Inclination
FDA Device · Class II · 2023-10-04 · Waldemar Link And Kg Mfg Site - 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482VF
FDA Device · Class II · 2023-10-04 · 3m Health Care Business - Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW-0004
FDA Device · Class II · 2023-10-04 · Fresenius Kabi Usa - PDS II (polydioxanone) Suture, Product Numbers Z844G-50, D10065-05, D10085-05, D6776-05, D6776-05, D9297-05, D9297-05, Z259H-50, Z259H-50,…
FDA Device · Class II · 2023-09-27 · Ethicon - Omnipod 5 Automated Insulin Delivery System
FDA Device · Class II · 2023-09-27 · Insulet - TyTek PneumoDart- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension p…
FDA Device · Class II · 2023-09-27 · Tytek Medical - VITROS XT Chemistry Products TBIL-ALKP Slides
FDA Device · Class II · 2023-09-27 · Ortho Clinical Diagnostics - Gallant HF Cardiac Resynchronization Therapy Defibrillator: HF CRT-D REF CDHFA500Q Neutrino HF Cardiac Resynchronization Therapy Defibrilla…
FDA Device · Class II · 2023-09-27 · Abbott Medical - Patient Information Center iX with Software Version Number 4.x in the following: (1) Patient Information Center iX Product Number: 866389;…
FDA Device · Class II · 2023-09-27 · Philips North America - APK2 Pressure-Sensing Wheelchair Cushions
FDA Device · Class II · 2023-09-27 · Aquila - SofTech Pressure-Sensing Wheelchair Cushions
FDA Device · Class II · 2023-09-27 · Aquila - DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm, REF: 508-01-032
FDA Device · Class II · 2023-09-27 · Encore Medical - COPAN REF: 2U045S01 300uL Transfer Pipette Individually wrapped pipettes, 1000 pcs
FDA Device · Class II · 2023-09-27 · Copan Diagnostics - Hamilton C1/T1/MR1, REF: MSP161502/12, Control Board Spare part for ventilator
FDA Device · Class I · 2023-09-27 · Hamilton Medical - FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 46827
FDA Device · Class II · 2023-09-27 · O And M Halyard - Membrane Changer Single-Use, REF MC, each package contains 3 changers
FDA Device · Class II · 2023-09-27 · Sentec Ag - Hamilton-T1, REF: 161009, Intensive Care and Transport Ventilator
FDA Device · Class I · 2023-09-27 · Hamilton Medical - Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator
FDA Device · Class I · 2023-09-27 · Hamilton Medical - DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106
FDA Device · Class II · 2023-09-27 · Encore Medical - Stryker ACM (Advanced Cement Mixing): 180-Gram Cement Cartridge with Breakaway Femoral Nozzle-Allows the user to mix bone cement with a con…
FDA Device · Class II · 2023-09-27 · Stryker - Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab AltiX and ComboLab AltiX
FDA Device · Class II · 2023-09-27 · Ge Medical Systems Information Technologies - Stryker ACM (Advanced Cement Mixing) System: Break-Away Femoral Nozzle-, Allows the user to mix bone cement with a constant high vacuum thr…
FDA Device · Class II · 2023-09-27 · Stryker - Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox
FDA Device · Class II · 2023-09-27 · Stryker - MINISCAV (tm) Vacuum Pump
FDA Device · Class II · 2023-09-27 · R A Medical Services - Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Solid Blades-Allows the user to mix bone cement with a c…
FDA Device · Class II · 2023-09-27 · Stryker - Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, and 00-1007, when Used With Tempus Pro Video…
FDA Device · Class II · 2023-09-27 · Remote Diagnostic Technologies - Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Prox
FDA Device · Class II · 2023-09-27 · Stryker - Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle-Allows the user to mix bone cement witha constant high vac…
FDA Device · Class II · 2023-09-27 · Stryker - Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet, REF CDC-35552-VPS
FDA Device · Class II · 2023-09-27 · Arrow International - TyTek Tension Pneumothorax Access Kit TPAK10: 10 gauge, 3.25 inch- Intended for introduction into the body to facilitate removal of air fro…
FDA Device · Class II · 2023-09-27 · Tytek Medical - Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only
FDA Device · Class II · 2023-09-27 · Karl Storz Endoscopy - Hamilton-MR1, REF: 161010, Intensive Care Ventilator
FDA Device · Class I · 2023-09-27 · Hamilton Medical - MEDLINE STERILE IRIS SCISSORS CVD/STD, REF DYNJ04049
FDA Device · Class II · 2023-09-27 · Medline Industries Northfield - Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part for ventilator
FDA Device · Class I · 2023-09-27 · Hamilton Medical - DJO Surgical: Altivate Reverse, Humeral Stem, Small Shell, Size 6 x 108mm, REF: 533-06-108
FDA Device · Class II · 2023-09-27 · Encore Medical - Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox
FDA Device · Class II · 2023-09-27 · Stryker - Perifix¿ / Epidural anesthesia set, medicated
FDA Device · Class II · 2023-09-27 · B Braun Medical - Hamilton-T1, REF: 161006, Intensive Care and Transport Ventilator
FDA Device · Class I · 2023-09-27 · Hamilton Medical - smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265
FDA Device · Class II · 2023-09-27 · Smith And Nephew - COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent RF channels, allowing all RF channels to be activat…
FDA Device · Class II · 2023-09-27 · Avanos Medical - DJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm, REF: 400-03-443
FDA Device · Class II · 2023-09-27 · Encore Medical - VITROS XT Chemistry Products ALKP Slides
FDA Device · Class II · 2023-09-27 · Ortho Clinical Diagnostics - TyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3.25 inch- Intended for introduction into the body to facilitate removal of air from th…
FDA Device · Class II · 2023-09-27 · Tytek Medical - DJO Surgical: CLP Hip, Stem, Polished Neck, Lateral Offset Implant, Size#3, REF: 426-11-030
FDA Device · Class II · 2023-09-27 · Encore Medical - PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50, PDP416H50, PDP441H50, PDP442H50, PDP489G50, PDP489H40,…
FDA Device · Class II · 2023-09-27 · Ethicon - Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A
FDA Device · Class II · 2023-09-27 · Arrow International - Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
FDA Device · Class II · 2023-09-27 · Randox Laboratories - Gallant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA500Q Gallant DR Implantable Cardioverter Defibrillator: DR ICD REF CDDRA…
FDA Device · Class II · 2023-09-27 · Abbott Medical - nanoDot D2DXS, Model Numbers: a) 03062-1MO
FDA Device · Class II · 2023-09-20 · Landauer - nanoDot D2DNS, for custom calibrate, OTO, Model Numbers 03034-OTO
FDA Device · Class II · 2023-09-20 · Landauer - nanoDot D2DXN, Model Numbers: a) 03061-1MO
FDA Device · Class II · 2023-09-20 · Landauer - nanoDot D2DNN, Model Numbers: a) 03051-1MO
FDA Device · Class II · 2023-09-20 · Landauer - Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide a marginal seal between the dentin and amalgam which helps to…
FDA Device · Class II · 2023-09-20 · Keystone Industries - nanoDot B - item 2 of 3 for 03500-000, Model Number 03502-000
FDA Device · Class II · 2023-09-20 · Landauer - Proclaim" XR 7 Implantable Pulse Generator REF 3662 (previously known as Proclaim" 7 Elite IPG) Product Description: The implantable pulse…
FDA Device · Class I · 2023-09-20 · Abbott Medical - Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators
FDA Device · Class I · 2023-09-20 · Mallinckrodt Manufacturing - nanoDot D2DNN, Model Numbers: a) 18105-000
FDA Device · Class II · 2023-09-20 · Landauer - QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 04218-000 (EMEA number VINLNAN004)
FDA Device · Class II · 2023-09-20 · Landauer - Proclaim Plus 7 Implantable Pulse Generator REF 3672 Product Description: The implantable pulse generator (IPG) is an electronic device des…
FDA Device · Class I · 2023-09-20 · Abbott Medical - Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Proclaim" 5 Elite IPG) Model 3660 Product Description: The implant…
FDA Device · Class I · 2023-09-20 · Abbott Medical - Calibrate (Cs-137) nanoDot D2DNS, Model Numbers: a) 04224-000 (EMEA number VINLNAN006)
FDA Device · Class II · 2023-09-20 · Landauer - Calibrate (Cs-137) nanoDot D2DNS, Model Numbers: a) 18125-000
FDA Device · Class II · 2023-09-20 · Landauer - nanoDot C - item 3 of 3 for 03500-000, Model Number 03503-000
FDA Device · Class II · 2023-09-20 · Landauer - ASG-001
FDA Device · Class II · 2023-09-20 · Advance Medical Designs - Infinity 5 Implantable Pulse Generator REF 6660 Product Description: The implantable pulse generator (IPG) is an electronic device designed…
FDA Device · Class I · 2023-09-20 · Abbott Medical - Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18120-000
FDA Device · Class II · 2023-09-20 · Landauer - Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI Item No.: 0921940HS Henry Schein Item No.: 570-0…
FDA Device · Class II · 2023-09-20 · Keystone Industries - nanoDot D2DNN , Model Numbers: a) 04293-000
FDA Device · Class II · 2023-09-20 · Landauer - nanoDot D2DXN, Model Numbers: a) 03060-1MO
FDA Device · Class II · 2023-09-20 · Landauer
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)