FDA Device · 2026
FDA Device recalls in 2026
RecallRadar indexes 2,388 FDA Device recall notices published in 2026. By classification: 287 Class I, 2,066 Class II, 35 Class III.
- Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as foll…
FDA Device · Class I · 2026-04-15 · Medline Industries - COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83-EXTU, Order Number G24073
FDA Device · Class II · 2026-04-15 · Cook - Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as foll…
FDA Device · Class I · 2026-04-15 · Medline Industries - Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single Bladder REF 5921-024-235 Stryker Sustainability Solu…
FDA Device · Class II · 2026-04-15 · Stryker Sustainability Solutions - COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, Order Number G57685
FDA Device · Class II · 2026-04-15 · Cook - COOK MEDICAL NCompass¿ Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3, Order Number G36250
FDA Device · Class II · 2026-04-15 · Cook - NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027
FDA Device · Class I · 2026-04-15 · Medline Industries - Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Device · Class II · 2026-04-15 · Spacelabs Healthcare - COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200, Order Number G07242
FDA Device · Class II · 2026-04-15 · Cook - Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as foll…
FDA Device · Class I · 2026-04-15 · Medline Industries - Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat
FDA Device · Class II · 2026-04-15 · Tornier - MicroScan Neg MIC 3J REF C54814
FDA Device · Class II · 2026-04-15 · Beckman Coulter - NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027
FDA Device · Class I · 2026-04-15 · Medline Industries - Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as foll…
FDA Device · Class I · 2026-04-15 · Medline Industries - NAMIC Angiographic Control Syringe, labeled as follows: 1. SYRINGE,7ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70083007
FDA Device · Class I · 2026-04-15 · Medline Industries - COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786
FDA Device · Class II · 2026-04-15 · Cook - COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number G50787
FDA Device · Class II · 2026-04-15 · Cook - Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number C-TCCSB-500-UNI, Order Number G32193
FDA Device · Class II · 2026-04-15 · Cook - Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as foll…
FDA Device · Class I · 2026-04-15 · Medline Industries - COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412
FDA Device · Class II · 2026-04-15 · Cook - MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative MIC…
FDA Device · Class II · 2026-04-15 · Beckman Coulter - Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as foll…
FDA Device · Class I · 2026-04-15 · Medline Industries - Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as foll…
FDA Device · Class I · 2026-04-15 · Medline Industries - Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as foll…
FDA Device · Class I · 2026-04-15 · Medline Industries - Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as foll…
FDA Device · Class I · 2026-04-15 · Medline Industries - Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as foll…
FDA Device · Class I · 2026-04-15 · Medline Industries - COOK MEDICAL Spectrum¿ Central Venous Catheter Set: Reference Part Number C-UDLM-401J-ABRM-HC, Order Number G43983
FDA Device · Class II · 2026-04-15 · Cook - Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as foll…
FDA Device · Class I · 2026-04-15 · Medline Industries - XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL
FDA Device · Class II · 2026-04-15 · Xtant Medical Holdings - COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order Number G56532
FDA Device · Class II · 2026-04-15 · Cook - COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775
FDA Device · Class II · 2026-04-15 · Cook - NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027
FDA Device · Class I · 2026-04-15 · Medline Industries - Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as foll…
FDA Device · Class I · 2026-04-15 · Medline Industries - See Luer Cap Set, MPC-130, set, administration, intravascular
FDA Device · Class II · 2026-04-15 · Molded Products - COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Order Number G57703
FDA Device · Class II · 2026-04-15 · Cook - COOK MEDICAL Spectrum¿ Central Venous Tray: Reference Part Number C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-RD, Order Number G44800
FDA Device · Class II · 2026-04-15 · Cook - Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as foll…
FDA Device · Class I · 2026-04-15 · Medline Industries - ALLURA Xper FD20 Biplane OR Table
FDA Device · Class II · 2026-04-08 · Philips Medical Systems Nederland B V - Burlington Medical, Kilt Blockers
FDA Device · Class II · 2026-04-08 · Burlington Medical - Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00
FDA Device · Class I · 2026-04-08 · Philips Respironics - Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)
FDA Device · Class II · 2026-04-08 · Medtronic Minimed - Philips Respironics Trilogy Evo, Software Version 1.05.15.00
FDA Device · Class I · 2026-04-08 · Philips Respironics - Burlington Medical, Kilt
FDA Device · Class II · 2026-04-08 · Burlington Medical - MiniMed 620G Insulin Pump (MMT-1750)
FDA Device · Class II · 2026-04-08 · Medtronic Minimed - Burlington Medical, Frontal Aprons
FDA Device · Class II · 2026-04-08 · Burlington Medical - MiniMed 640G Insulin Pump (MMT-1711, MMT-1712, MMT-1751, MMT-1752)
FDA Device · Class II · 2026-04-08 · Medtronic Minimed - Burlington Medical, Protective Sleeves
FDA Device · Class II · 2026-04-08 · Burlington Medical - eTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-158
FDA Device · Class II · 2026-04-08 · Civco Medical Instruments - Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter Model/Catalog Number: FS252251502 Product Descripti…
FDA Device · Class II · 2026-04-08 · Summa Therapeutics - Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777
FDA Device · Class II · 2026-04-08 · Cardinal Health 200 - SIGNA Premier systems
FDA Device · Class II · 2026-04-08 · Ge Healthcare - 2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US
FDA Device · Class II · 2026-04-08 · Synthes Usa Products - Burlington Medical, Leg Wraps
FDA Device · Class II · 2026-04-08 · Burlington Medical - Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS-068-02 Product Descr…
FDA Device · Class II · 2026-04-08 · Recor Medical - Paradigm REAL-Time Veo Insulin Pump (MMT-554, MMT-754)
FDA Device · Class II · 2026-04-08 · Medtronic Minimed - MiniMed 530G Insulin Pump (MMT-551, MMT-751)
FDA Device · Class II · 2026-04-08 · Medtronic Minimed - Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Name: da Vinci S, Si Double Fenestrated Grasper Instrument Model/C…
FDA Device · Class II · 2026-04-08 · Intuitive Surgical - Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937
FDA Device · Class I · 2026-04-08 · Baxter Healthcare - MiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)
FDA Device · Class II · 2026-04-08 · Medtronic Minimed - Vue Motion V12
FDA Device · Class II · 2026-04-08 · Philips Medical Systems Nederland B V - Burlington Medical, Caps
FDA Device · Class II · 2026-04-08 · Burlington Medical - Azurion 7 M12
FDA Device · Class II · 2026-04-08 · Philips Medical Systems Nederland B V - eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149
FDA Device · Class II · 2026-04-08 · Civco Medical Instruments - eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157
FDA Device · Class II · 2026-04-08 · Civco Medical Instruments - Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722)
FDA Device · Class II · 2026-04-08 · Medtronic Minimed - Paradigm Insulin Pump (MMT-712, MMT-715)
FDA Device · Class II · 2026-04-08 · Medtronic Minimed - Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFL-SLS Model/Catalog Number: TFL-SLS conta…
FDA Device · Class II · 2026-04-08 · Olympus - ALLURA Xper FD10 OR Table
FDA Device · Class II · 2026-04-08 · Philips Medical Systems Nederland B V - eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150
FDA Device · Class II · 2026-04-08 · Civco Medical Instruments - Allura Xper FD20/15
FDA Device · Class II · 2026-04-08 · Philips Medical Systems Nederland B V - BD Kiestra" ReadA
FDA Device · Class II · 2026-04-08 · Bd Kiestra Lab Automation - Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135RH TEXP140RH TEXP150RH Textured, High &…
FDA Device · Class II · 2026-04-08 · Mentor Texas - Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, CA
FDA Device · Class I · 2026-04-08 · Abiomed - Azurion 7 B20
FDA Device · Class II · 2026-04-08 · Philips Medical Systems Nederland B V - Medline convenience kits containing Olympus biopsy valves: 1. BRONCH PACK, DYKE2096 2. NON MB BRONCHOPSCOPY CCH LH PK, DYNJT6182 3. PULMONA…
FDA Device · Class II · 2026-04-08 · Medline Industries - CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650cc
FDA Device · Class II · 2026-04-08 · Mentor Texas - Allura Xper FD10C
FDA Device · Class II · 2026-04-08 · Philips Medical Systems Nederland B V - Azurion 7 M20
FDA Device · Class II · 2026-04-08 · Philips Medical Systems Nederland B V - Burlington Medical, BAT (Breast, Axilla and Thyroid) Coverage
FDA Device · Class II · 2026-04-08 · Burlington Medical - MiniMed 780G Insulin Pump (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896)
FDA Device · Class II · 2026-04-08 · Medtronic Minimed - Sterile Radiology Procedure Kits, Model Number DYNDH1491B
FDA Device · Class II · 2026-04-08 · Medline Industries - RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
FDA Device · Class II · 2026-04-08 · Reflexion Medical - Philips Respironics Trilogy EV300, Software Version 1.05.15.00
FDA Device · Class I · 2026-04-08 · Philips Respironics - Azurion 5 M20
FDA Device · Class II · 2026-04-08 · Philips Medical Systems Nederland B V - Medline Kits containing ENFIT G-TUBE CONNECTOR 1. SKU DYKM2720 G/J TUBE CARE KIT 2. SKU ENFITDISCKIT ENFIT DISCHARGE KIT
FDA Device · Class II · 2026-04-08 · Medline Industries - Burlington Medical, Half Aprons
FDA Device · Class II · 2026-04-08 · Burlington Medical - Azurion 7 B12
FDA Device · Class II · 2026-04-08 · Philips Medical Systems Nederland B V - Azurion 3 M12
FDA Device · Class II · 2026-04-08 · Philips Medical Systems Nederland B V - Azurion 5 M12
FDA Device · Class II · 2026-04-08 · Philips Medical Systems Nederland B V - Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci S, Si Tenaculum Forceps Instrument Model/Catalog Number: 420…
FDA Device · Class II · 2026-04-08 · Intuitive Surgical - Burlington Medical, Demi Half Aprons
FDA Device · Class II · 2026-04-08 · Burlington Medical - CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-113TH, SCPX-123TH, SCPX-140TH, SCPX-146TH Smooth Tall Height Tiss…
FDA Device · Class II · 2026-04-08 · Mentor Texas - Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001
FDA Device · Class II · 2026-04-08 · Stryker Communications - ALLURA Xper FD10F
FDA Device · Class II · 2026-04-08 · Philips Medical Systems Nederland B V - Allura Xper FD20/10
FDA Device · Class II · 2026-04-08 · Philips Medical Systems Nederland B V - Burlington Medical, Wrap Aprons
FDA Device · Class II · 2026-04-08 · Burlington Medical - eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151
FDA Device · Class II · 2026-04-08 · Civco Medical Instruments - Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS-068-02 Product Descr…
FDA Device · Class II · 2026-04-08 · Recor Medical - Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H SDC-130H SDC-135H SDC-140H SDC-150H SDC-155H Smooth High Prof…
FDA Device · Class II · 2026-04-08 · Mentor Texas - 2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US
FDA Device · Class II · 2026-04-08 · Synthes Usa Products
Other years
2026 (2,388) · 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)