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.
- Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
FDA Device · Class II · 2026-08-12 · Siemens Healthcare Diagnostics - Kingfisher Compact Individual First Aid Kit
FDA Device · Class II · 2026-08-12 · Integrated Medcraft - Brand Name: Quantum Rehab Product Name: Q6 Edge HD Model/Catalog Number: Q6 Edge HD Software Version: 2.0.11, new version: 2.0.13 Product D…
FDA Device · Class II · 2026-08-12 · Pride Mobility Products - Brand Name: WASPLab Product Name: WASPLab Model/Catalog Number: W087 Software Version: WebApp version 2.33.1, 2.33.3 and 2.34.2 Product Des…
FDA Device · Class II · 2026-08-12 · Copan Wasp - Philips Allura, Cardio Vascular-Allura Centron
FDA Device · Class II · 2026-08-12 · Philips Medical Systems Nederland B V - Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds
FDA Device · Class I · 2026-08-12 · Avid Medical - Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 6677300 Flow-i C40 6677400 Flow-i C20 6888520 Flow-i C30 6888530 Flow-i C40 6888540 F…
FDA Device · Class II · 2026-08-12 · Maquet Critical Care Ab - Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
FDA Device · Class III · 2026-08-12 · Siemens Healthcare Diagnostics - Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory support for patients…
FDA Device · Class I · 2026-08-05 · Resmed - Stryker Hoffmann II Connecting Rod Micro 3 x 120mm
FDA Device · Class II · 2026-08-05 · Stryker - EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Num…
FDA Device · Class II · 2026-08-05 · Medtronic Perfusion Systems - Stryker Hoffmann II Connecting Rod Micro 3 x 90mm
FDA Device · Class II · 2026-08-05 · Stryker - L-Cath PICC S/L Peripherally Inserted Central Catheter: 26ga (1.9F) 0.60mm x 30cm, REF: 384539
FDA Device · Class II · 2026-08-05 · Argon Medical Devices - Stryker Hoffmann II Connecting Rod Micro 3 x 40mm
FDA Device · Class II · 2026-08-05 · Stryker - IQon Spectral CT IQon Spectral CT Upgrades
FDA Device · Class II · 2026-08-05 · Philips Medical Systems - AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Laminectomy Pack, Pack Number AMS13574A
FDA Device · Class II · 2026-08-05 · Windstone Medical Packaging - AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Nerve Block Tray - RX, Part Number AMS13975A
FDA Device · Class II · 2026-08-05 · Windstone Medical Packaging - AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Neuro Pack, Pack Number AMS12195C
FDA Device · Class II · 2026-08-05 · Windstone Medical Packaging - Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Brilliance 64 Upgrades
FDA Device · Class II · 2026-08-05 · Philips Medical Systems - Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Portable blood analyzer system
FDA Device · Class II · 2026-08-05 · Instrumentation Laboratory - M5 Corpus Power Wheelchair REF,120032
FDA Device · Class II · 2026-08-05 · Permobil - AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Port Tray - RX, Part Number 008786-19
FDA Device · Class II · 2026-08-05 · Windstone Medical Packaging - AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Pack Number AMS12206
FDA Device · Class II · 2026-08-05 · Windstone Medical Packaging - AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Heart Cath Tray - RX, Part Number DDS1159B
FDA Device · Class II · 2026-08-05 · Windstone Medical Packaging - Power Over Fiber Base Module
FDA Device · Class II · 2026-08-05 · Terex Utilities - EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78322
FDA Device · Class II · 2026-08-05 · Medtronic Perfusion Systems - Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium Ingenuity CT Upgrades Ingenuity CT China Ingenuity Core 12…
FDA Device · Class II · 2026-08-05 · Philips Medical Systems - AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Dr Fred Chiu Single Shot Epi Tray - Rx, Part Number AMS1095(E
FDA Device · Class II · 2026-08-05 · Windstone Medical Packaging - Brand Name: GEM Premier 7000 with iQM3 Product Name: GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Intelligent Quality Manag…
FDA Device · Class II · 2026-08-05 · Instrumentation Laboratory - Stryker Hoffmann II Connecting Rod Micro 3 x 30mm
FDA Device · Class II · 2026-08-05 · Stryker - OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095
FDA Device · Class II · 2026-08-05 · Isotis Orthobiologics - AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Block Tray - RX, Part Number AMS12414
FDA Device · Class II · 2026-08-05 · Windstone Medical Packaging - EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model N…
FDA Device · Class II · 2026-08-05 · Medtronic Perfusion Systems - Pack Angiography NCMC 3/Cs BANNER, REF: NCAG62I, containing Medline Namic Angiographic Star Off Handle Manifolds
FDA Device · Class I · 2026-08-05 · Medical Action Industries 306 - AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Part Number AMS10411B
FDA Device · Class II · 2026-08-05 · Windstone Medical Packaging - L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm, REF: 384620
FDA Device · Class II · 2026-08-05 · Argon Medical Devices - EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78222
FDA Device · Class II · 2026-08-05 · Medtronic Perfusion Systems - AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Angio Pack - RX, Part Number AMS9461
FDA Device · Class II · 2026-08-05 · Windstone Medical Packaging - Stryker Hoffmann II Connecting Rod Micro 3 x 50mm
FDA Device · Class II · 2026-08-05 · Stryker - EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model N…
FDA Device · Class II · 2026-08-05 · Medtronic Perfusion Systems - Stryker Hoffmann II Connecting Rod Micro 3 x 150mm
FDA Device · Class II · 2026-08-05 · Stryker - Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Portable blood analyzer system
FDA Device · Class II · 2026-08-05 · Instrumentation Laboratory - GEM Premier 5000 with IQM2 Model/Catalog Number: 00024019255 and GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Portable bloo…
FDA Device · Class II · 2026-08-05 · Instrumentation Laboratory - EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Num…
FDA Device · Class II · 2026-08-05 · Medtronic Perfusion Systems - Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system
FDA Device · Class II · 2026-08-05 · Instrumentation Laboratory - Permobil M3 Corpus Power Wheelchair with Heavy Duty Shock REF:120031, Model version 3
FDA Device · Class II · 2026-08-05 · Permobil - AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: SPINAL KIT, Part Number AMS13683A
FDA Device · Class II · 2026-08-05 · Windstone Medical Packaging - Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system
FDA Device · Class II · 2026-08-05 · Instrumentation Laboratory - Stryker Hoffmann II Connecting Rod Micro 3 x 60mm
FDA Device · Class II · 2026-08-05 · Stryker - AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Loop Recorder Pack 2 -RX, Part Number AMS10164
FDA Device · Class II · 2026-08-05 · Windstone Medical Packaging - MEDLINE medical procedure convenience kit labeled as: HIP CDS-LF, Medline kit SKU CDS984556N
FDA Device · Class I · 2026-07-29 · Medline Industries - FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M…
FDA Device · Class II · 2026-07-29 · Boston Scientific - Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4
FDA Device · Class II · 2026-07-29 · Olympus - Ventriculostomy Kit, REF: 46154
FDA Device · Class II · 2026-07-29 · Medtronic Neurosurgery - Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons
FDA Device · Class II · 2026-07-29 · Medline Industries - MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G
FDA Device · Class I · 2026-07-29 · Medline Industries - 3mensio Workstation (Vascular Fenestrated) software
FDA Device · Class II · 2026-07-29 · Pie Medical Imaging B V - Medline medical convenience kits labeled as: 1) SHOULDER PACK, Medline Kit SKU DYNJ39590O
FDA Device · Class II · 2026-07-29 · Medline Industries - FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401
FDA Device · Class II · 2026-07-29 · Boston Scientific - FARASTAR PFA Generator, Product ID M004PFCE61M460
FDA Device · Class II · 2026-07-29 · Boston Scientific - Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons
FDA Device · Class II · 2026-07-29 · Medline Industries - Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
FDA Device · Class II · 2026-07-29 · Penumbra - FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402,…
FDA Device · Class II · 2026-07-29 · Boston Scientific - Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons
FDA Device · Class II · 2026-07-29 · Medline Industries - Medline medical convenience kits labeled as: NEURO PACK, Medline Kit SKU DYNJ59397P
FDA Device · Class II · 2026-07-29 · Medline Industries - Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF PED2-300-12
FDA Device · Class II · 2026-07-29 · Micro Therapeutics - Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons
FDA Device · Class II · 2026-07-29 · Medline Industries - Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons
FDA Device · Class II · 2026-07-29 · Medline Industries - Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the patient's intravenou…
FDA Device · Class II · 2026-07-29 · Icu Medical - Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons
FDA Device · Class II · 2026-07-29 · Medline Industries - Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01
FDA Device · Class II · 2026-07-29 · Avid Medical - SnapshotGLO Wound Imaging Device, Model KB100, KB100AA
FDA Device · Class II · 2026-07-29 · Kent Imaging - MEDLINE convenience kits labeled as: 1) TOTAL JOINT KIT, Medline Kit SKU DYKS1574A
FDA Device · Class I · 2026-07-29 · Medline Industries - Emano Flow with software version v2.0.0 GS1 GTIN code: 199874903484 Emano Flow is a smartphone-based acoustic uroflowmetry system
FDA Device · Class II · 2026-07-29 · Emano Metrics - Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons
FDA Device · Class II · 2026-07-29 · Medline Industries - The intended use is to be paired with a weapon for aiming purposes
FDA Device · Class II · 2026-07-29 · Wilcox Industries - Medline medical convenience kits labeled as: 1) KIT PEDIATRIC OPEN HEART MOSES, Medline Kit SKU DYNJ910103B
FDA Device · Class II · 2026-07-29 · Medline Industries - SeaSpine Polyaxial Head REF Number: 41-3010
FDA Device · Class II · 2026-07-29 · Seaspine Orthopedics - MEDLINE convenience kits labeled as: 1) C-SECTION, Medline SKU DYNJ910835
FDA Device · Class I · 2026-07-29 · Medline Industries - FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401
FDA Device · Class II · 2026-07-29 · Boston Scientific - Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons
FDA Device · Class II · 2026-07-29 · Medline Industries - Power F2 Powered Fastening System, Product No. 0567091 Powered fastening system intended for professional use only
FDA Device · Class II · 2026-07-29 · Ferno Washington - Halyard EYE PACK. Model/Catalog Number: LVEY27 Convenience kit
FDA Device · Class II · 2026-07-29 · Avid Medical - Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20
FDA Device · Class II · 2026-07-29 · Micro Therapeutics - FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004…
FDA Device · Class II · 2026-07-29 · Boston Scientific - SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
FDA Device · Class II · 2026-07-29 · Alphatec Spine - Brand Name: Silent Nite Product Name: Silent Nite Sleep Appliance Model/Catalog Number: SILNT Product Description: Silent Nite Sleep Applia…
FDA Device · Class II · 2026-07-29 · Prismatik Dentalcraft - Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons
FDA Device · Class II · 2026-07-29 · Medline Industries - Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001
FDA Device · Class II · 2026-07-29 · Boston Scientific - FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401
FDA Device · Class II · 2026-07-29 · Boston Scientific - MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)
FDA Device · Class II · 2026-07-29 · Medtronic Minimed - Olympus 4K UHD LCD Monitor
FDA Device · Class II · 2026-07-29 · Olympus - Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1
FDA Device · Class II · 2026-07-29 · Karl Storz Endoscopy - MEDLINE medical procedure convenience kit labeled as: 1) TOTAL KNEE-LF, Medline kit SKU CDSOPT590T
FDA Device · Class I · 2026-07-29 · Medline Industries - FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21C6…
FDA Device · Class II · 2026-07-29 · Boston Scientific - P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm, ITem number P31-955-…
FDA Device · Class II · 2026-07-29 · Paragon 28 - Medline medical convenience kits labeled as: 1) TOTAL JOINT PACK Medline Kit SKU DYNJ65065A: 2) EXTREMITY/FOOT PACK Medline Kit SKU DYNJ650…
FDA Device · Class II · 2026-07-29 · Medline Industries - Papablic Replacement Brush Heads
FDA Device · Class II · 2026-07-22 · Papablic - ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit, 14Fr Introducer, 25cm, Long Taper, Introducer Prod…
FDA Device · Class I · 2026-07-22 · Abiomed - ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr Introducer, 11cm, Sterile, Introducer Product Code 2000342…
FDA Device · Class I · 2026-07-22 · Abiomed
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)