FDA Device · 2026
FDA Device recalls in 2026
RecallRadar indexes 2,024 FDA Device recall notices published in 2026. By classification: 254 Class I, 1,736 Class II, 34 Class III.
- Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-5320
FDA Device · Class II · 2026-06-17 · Avanos Medical - Halyard, Towel Six Pack
FDA Device · Class II · 2026-06-17 · Avid Medical - Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-4320
FDA Device · Class II · 2026-06-17 · Avanos Medical - Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PUSH OTW Model/Catalog Number: 8170-14 Pro…
FDA Device · Class II · 2026-06-17 · Avanos Medical - CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030
FDA Device · Class II · 2026-06-17 · Inspiremd - CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040
FDA Device · Class II · 2026-06-17 · Inspiremd - Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
FDA Device · Class II · 2026-06-17 · Boston Scientific Neuromodulation - NeoSpan¿ SuperElastic Compression Staple w/Instruments Catalog Number and Product Name T50 SN010 NeoSpan¿ SuperElastic Compression Staple w…
FDA Device · Class II · 2026-06-17 · In2bones Usa - Boston Scientific TCN Electrodes: REF: TCN-5, TCN Electrode, NITINOL, 5 cm x 0.45 mm (0.0175 in)
FDA Device · Class II · 2026-06-17 · Boston Scientific Neuromodulation - SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, Software Version: firmware 2021.02, 2022.01 or 2022.02
FDA Device · Class II · 2026-06-17 · Micromed S P A - Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Model/Catalog…
FDA Device · Class II · 2026-06-17 · Hf Acquisition - Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PUSH OTW Model/Catalog Number: 7170-24 Product Description: Feed…
FDA Device · Class II · 2026-06-17 · Avanos Medical - Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
FDA Device · Class II · 2026-06-17 · Abbott Medical - TDC VELOCE", 23G Two Dimensional Cutter - 20k CPM
FDA Device · Class II · 2026-06-17 · D O R C Dutch Opthalmic Research Center Intl B V - Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PUSH OTW Model/Catalog Number: 7170-20 Product Description: Feed…
FDA Device · Class II · 2026-06-17 · Avanos Medical - Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6316
FDA Device · Class II · 2026-06-17 · Avanos Medical - Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PUSH OTW Model/Catalog Number: 7170-14 Product Description: Feed…
FDA Device · Class II · 2026-06-17 · Avanos Medical - Allia IGS 7 Pulse angiographic X-ray system
FDA Device · Class II · 2026-06-17 · Ge Medical Systems - Plum Duo Infusion Pump, 40002-0401
FDA Device · Class II · 2026-06-17 · Icu Medical - CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND0930
FDA Device · Class II · 2026-06-17 · Inspiremd - Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PUSH OTW Model/Catalog Number: 8170-20
FDA Device · Class II · 2026-06-17 · Avanos Medical - Allia IGS 5 Pulse angiographic X-ray system
FDA Device · Class II · 2026-06-17 · Ge Medical Systems - Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PULL Model/Catalog Number: 8180-24
FDA Device · Class II · 2026-06-17 · Avanos Medical - BD Pyxis MedStation ES Tower REF: 352 Medication cabinet
FDA Device · Class II · 2026-06-10 · Carefusion 303 - Digital Angiography System Trinias:UD150G-40 / D150GC-40
FDA Device · Class II · 2026-06-10 · Shimadzu Medical Systems - Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro So…
FDA Device · Class II · 2026-06-10 · Philips Medical Systems Nederland B V - Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK SHANDS JACKSONVILLE 20055717 Model/Catalog Number: 555884 Software Version: N/A Produc…
FDA Device · Class II · 2026-06-10 · B Braun Medical - Design Options Spinal Tray Spinal Needle Anesthesia procedure kits: Material Description (Material Number): SSK H M C 20061890 (560074), SS…
FDA Device · Class I · 2026-06-10 · B Braun Medical - ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
FDA Device · Class II · 2026-06-10 · Siemens Medical Solutions Usa - Sharpoint 2.2MM, ANGLED, DOUBLE- BEVEL Model/Catalog Number: 72-2231 Microsurgical Knife
FDA Device · Class II · 2026-06-10 · Ssc Surgical Specialties - Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Model/Catalog Number: CI-1601-04 Software Ver…
FDA Device · Class II · 2026-06-10 · Advanced Bionics - Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK RIVERSIDE HEALTH SYSTEM Model/Catalog Number: 552126 Software Version: N/A Product Des…
FDA Device · Class II · 2026-06-10 · B Braun Medical - BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in., BD¿Quincke Needle 22 G x 3.5 in
FDA Device · Class I · 2026-06-10 · Becton Dickinson And - Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042
FDA Device · Class II · 2026-06-10 · Covidien - Brand Name: B. BRAUN MEDICAL INC. Product Name: LYNDON B JOHNSON HOSPITAL SPINAL EPID Model/Catalog Number: 530184 Software Version: N/A Pr…
FDA Device · Class II · 2026-06-10 · B Braun Medical - BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in
FDA Device · Class I · 2026-06-10 · Becton Dickinson And - PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050
FDA Device · Class II · 2026-06-10 · Oculus Technologies - Brand Name: B. BRAUN MEDICAL INC. Product Name: BPSK, BLOCKJOCKS TRAY Model/Catalog Number: 570246 Software Version: N/A Product Descriptio…
FDA Device · Class II · 2026-06-10 · B Braun Medical - Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software k…
FDA Device · Class II · 2026-06-10 · Philips Medical Systems Nederland B V - BD Pyxis Anesthesia Station ES REF: 327 Medication cabinet
FDA Device · Class II · 2026-06-10 · Carefusion 303 - ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600
FDA Device · Class II · 2026-06-10 · Siemens Medical Solutions Usa - CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3
FDA Device · Class II · 2026-06-10 · Ge Medical Systems Information Technologies - BD¿Spinal Tray with BD¿Whitacre Needle 24 G x 3.5 in
FDA Device · Class I · 2026-06-10 · Becton Dickinson And - Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050
FDA Device · Class II · 2026-06-10 · Covidien - Brand Name: B. BRAUN MEDICAL INC. Product Name: SESK UPMC DOUBLE CATHETER TRAY Model/Catalog Number: 530134 Software Version: N/A Product D…
FDA Device · Class II · 2026-06-10 · B Braun Medical - Philips Azurion 7M12, Model Numbers: 722078, 722223 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro So…
FDA Device · Class II · 2026-06-10 · Philips Medical Systems Nederland B V - BD¿Spinal Tray with BD¿Quincke Needle 25 G x 3.5 in
FDA Device · Class I · 2026-06-10 · Becton Dickinson And - Brand Name: B. BRAUN MEDICAL INC. Product Name: NES1725KFXL SPINAL EPID CLOSED TIP CATH Model/Catalog Number: 530201 Software Version: N/A…
FDA Device · Class II · 2026-06-10 · B Braun Medical - COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are intended for use in provid…
FDA Device · Class II · 2026-06-10 · Covidien - BD Pyxis MedBank Tower REF: 1145-00 Medication cabinet
FDA Device · Class II · 2026-06-10 · Carefusion 303 - Covidien EndoStitch" Polysorb Single Use Loading Unit
FDA Device · Class II · 2026-06-10 · Covidien - Atlan A350XL. Model Number: 8621600. anesthesia workstation
FDA Device · Class I · 2026-06-10 · Draeger - Spinocan Spinal Needle procedure kits: Material Description (Material Number): Spinocan 26 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with…
FDA Device · Class I · 2026-06-10 · B Braun Medical - BD¿Spinal Tray with BD¿Quincke Needle 22 G x 3.5 in
FDA Device · Class I · 2026-06-10 · Becton Dickinson And - Pediatric care bed
FDA Device · Class I · 2026-06-10 · Kayserbetten And Kg - Spinal Needle procedure kits: Material Description (Material Number) 24GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333867)
FDA Device · Class I · 2026-06-10 · B Braun Medical - LVP software of the Ivenix Infusion System (IIS)
FDA Device · Class I · 2026-06-10 · Fresenius Kabi Usa - Philips Azurion 7B12/12, Model Numbers: 722067, 722225 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro…
FDA Device · Class II · 2026-06-10 · Philips Medical Systems Nederland B V - BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in
FDA Device · Class I · 2026-06-10 · Becton Dickinson And - Aligned Medical AMS16835 Fluids Kit RX
FDA Device · Class II · 2026-06-10 · Windstone Medical Packaging - Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK HARRIS METHODIST Model/Catalog Number: 555498 Software Version: N/A Product Descriptio…
FDA Device · Class II · 2026-06-10 · B Braun Medical - TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis
FDA Device · Class II · 2026-06-10 · Grace Medical - Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog Number: H938175 Product Description: Tubing sets with push-on…
FDA Device · Class II · 2026-06-10 · Baxter Healthcare - Arvis Hip & Knee 3.0 Instrument Set, REF: IN-28000 containing one of the following components: IN-10500, Impactor V-Block Assembly
FDA Device · Class II · 2026-06-10 · Kico Knee Innovation - Covidien Mon-a-Therm General Purpose Temperature Probe REF: 90044
FDA Device · Class II · 2026-06-10 · Covidien - Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro So…
FDA Device · Class II · 2026-06-10 · Philips Medical Systems Nederland B V - Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
FDA Device · Class I · 2026-06-10 · Fresenius Kabi Usa - Atlan A350
FDA Device · Class I · 2026-06-10 · Draeger - The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004
FDA Device · Class II · 2026-06-10 · Fresenius Kabi Usa - BD Pyxis MedBank Mini REF: 1147-00 Medication cabinet
FDA Device · Class II · 2026-06-10 · Carefusion 303 - BD Pyxis Anesthesia Station 4000 REF: 338 Medication cabinet
FDA Device · Class II · 2026-06-10 · Carefusion 303 - BD Pyxis MedStation ES REF: 323 Medication cabinet
FDA Device · Class II · 2026-06-10 · Carefusion 303 - MAC 5 A4 Resting ECG Analysis System 855001-001
FDA Device · Class II · 2026-06-10 · Ge Medical Systems China - DeRoyal Industries Inc
FDA Device · Class II · 2026-06-10 · Deroyal Industries - Neptune Smart Docking Station (120V), Catalog Number 0770-100-000, part of the Neptune Waste Management System
FDA Device · Class II · 2026-06-10 · Stryker - BD Pyxis MedStation 4000 REF: 303 Medication cabinet
FDA Device · Class II · 2026-06-10 · Carefusion 303 - BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in
FDA Device · Class I · 2026-06-10 · Becton Dickinson And - Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software k…
FDA Device · Class II · 2026-06-10 · Philips Medical Systems Nederland B V - Philips Azurion 7B20/15, Model Numbers: 722068, 722226 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro…
FDA Device · Class II · 2026-06-10 · Philips Medical Systems Nederland B V - Phothera 200, Phototherapy Devices indicated for use to treat diagnosed skin disorders such as, but not limited to, Psoriasis, Vitiligo, an…
FDA Device · Class II · 2026-06-10 · Daavlin Distributing - BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in
FDA Device · Class I · 2026-06-10 · Becton Dickinson And - BD¿Spinal Tray with BD¿Quincke Needle 26 G x 3.5 in
FDA Device · Class I · 2026-06-10 · Becton Dickinson And - Brand Name: B. BRAUN MEDICAL INC Product Name: CESK NORTHSIDE ANESTHESIA TRAY Model/Catalog Number: 555076 Software Version: N/A Product De…
FDA Device · Class II · 2026-06-10 · B Braun Medical - Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the Medrad¿ Avanta Injection System
FDA Device · Class II · 2026-06-10 · Bayer Medical Care - Arvis Hip & Knee 2.0 Instrument Set, REF: IN-21200 containing one of the following components: IN-10500, Impactor V-Block Assembly
FDA Device · Class II · 2026-06-10 · Kico Knee Innovation - Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface:…
FDA Device · Class II · 2026-06-10 · Intuitive Surgical - Philips Azurion 7M20, Model Numbers: 722079, 722224 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro So…
FDA Device · Class II · 2026-06-10 · Philips Medical Systems Nederland B V - BD Pyxis Mini Main REF: 349 Medication cabinet
FDA Device · Class II · 2026-06-10 · Carefusion 303 - BD¿Spinal Tray with BD¿Whitacre Needle 22 G x 3.5 in
FDA Device · Class I · 2026-06-10 · Becton Dickinson And - Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA
FDA Device · Class I · 2026-06-03 · Abiomed - GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA
FDA Device · Class II · 2026-06-03 · Ge Medical Systems Information Technologies - Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) ANESTHESIA TRAY, Medline SKU DYNJRA1355A
FDA Device · Class I · 2026-06-03 · Medline Industries - Medline medical convenience kit labeled as EYE TRAY-LF, Medline Kit SKU DYNJ21627P
FDA Device · Class II · 2026-06-03 · Medline Industries - Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) PAIN TRAY, Medline Kit SKU DYNJRA1555
FDA Device · Class I · 2026-06-03 · Medline Industries - Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002
FDA Device · Class II · 2026-06-03 · Medtronic Neuromodulation - Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA1097
FDA Device · Class I · 2026-06-03 · Medline Industries - Azurion system
FDA Device · Class II · 2026-06-03 · Philips Medical Systems Nederland B V - GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV
FDA Device · Class II · 2026-06-03 · Ge Medical Systems Information Technologies - GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER, REF #2108729-901, Product Code SS9
FDA Device · Class II · 2026-06-03 · Ge Medical Systems Information Technologies - GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product Code KSA
FDA Device · Class II · 2026-06-03 · Ge Medical Systems Information Technologies
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)