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.
- Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL ANESTHESIA TRAY-LF, Medline Kit SKU DYN…
FDA Device · Class I · 2026-06-03 · Medline Industries - GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by GE Service only, REF #2108523-01
FDA Device · Class II · 2026-06-03 · Ge Medical Systems Information Technologies - Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001
FDA Device · Class II · 2026-06-03 · Medtronic Neuromodulation - Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL TRAY W/PENCIL POINT NDL, Medline Kit SK…
FDA Device · Class I · 2026-06-03 · Medline Industries - Automated Impella Controller (AIC)
FDA Device · Class I · 2026-06-03 · Abiomed - Allura system
FDA Device · Class II · 2026-06-03 · Philips Medical Systems Nederland B V - HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
FDA Device · Class II · 2026-06-03 · Devicor Medical Products - Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.), 48775 (Xl)
FDA Device · Class II · 2026-06-03 · O And M Halyard - Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: SPINAL BLOCK 22G QUINCKE 5S BU, Medline Kit SKU D…
FDA Device · Class I · 2026-06-03 · Medline Industries - GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Product Code SS9
FDA Device · Class II · 2026-06-03 · Ge Medical Systems Information Technologies - RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-164-28U 28-N4-32-164-32U 28-N4-32-209-28U…
FDA Device · Class I · 2026-06-03 · Bolton Medical - Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) BLOCK TRAY, Medline Kit SKU DYNJRA1181C
FDA Device · Class I · 2026-06-03 · Medline Industries - Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725
FDA Device · Class II · 2026-05-27 · Medtronic Perfusion Systems - Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T
FDA Device · Class II · 2026-05-27 · Medtronic Perfusion Systems - Swan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6/096F6P, C144F7, 782F75M, 132F5, C146F7, 831F75/831F75P, TS105…
FDA Device · Class II · 2026-05-27 · Becton Dickinson And - Tangent Endoscopy, Tangent Single Use Digital Catheter
FDA Device · Class II · 2026-05-27 · Tangent Endoscopy - OneLIF Interbody Cage (REF/Description): 010-107-1007/Small 7 Degree 10mm X 7mm, 010-107-1007-2/Small 7 Degree 10mm X 7mm - Oblique, 010-10…
FDA Device · Class II · 2026-05-27 · Novapproach Spine - Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros
FDA Device · Class II · 2026-05-27 · Icu Medical - Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33418 33420 33422 33424 Silastic Brand Foley Catheter 5cc REF: 33614…
FDA Device · Class II · 2026-05-27 · C R Bard - Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913
FDA Device · Class II · 2026-05-27 · Medtronic Perfusion Systems - Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T
FDA Device · Class II · 2026-05-27 · Medtronic Perfusion Systems - Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965
FDA Device · Class II · 2026-05-27 · Medtronic Perfusion Systems - Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P
FDA Device · Class II · 2026-05-27 · Becton Dickinson And - Integris-Allura system
FDA Device · Class II · 2026-05-27 · Philips Medical Systems Nederland B V - Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665
FDA Device · Class II · 2026-05-27 · Medtronic Perfusion Systems - Azurion system
FDA Device · Class II · 2026-05-27 · Philips Medical Systems Nederland B V - Swan-Ganz Pacing Catheter, Models: D200F7
FDA Device · Class II · 2026-05-27 · Becton Dickinson And - Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T
FDA Device · Class II · 2026-05-27 · Medtronic Perfusion Systems - Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915
FDA Device · Class II · 2026-05-27 · Medtronic Perfusion Systems - Philips Azurion systems not configured with an optional auxiliary pan handle
FDA Device · Class II · 2026-05-27 · Philips Medical Systems Nederland B V - Allura system
FDA Device · Class II · 2026-05-27 · Philips Medical Systems Nederland B V - Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L
FDA Device · Class II · 2026-05-27 · Medtronic Perfusion Systems - BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions - Daig Livewire Steerable, Product Number 401652
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions - Philips Azurion
FDA Device · Class II · 2026-05-20 · Philips Medical Systems Nederland B V - BARD Dynamic Tip Steerable, Product Number 200344
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions - Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23
FDA Device · Class II · 2026-05-20 · Ge Medical Systems - Daig Livewire Steerable, Product Number 401582
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions - Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200
FDA Device · Class I · 2026-05-20 · Medline Industries - Namic Preceptor Manifold, custom, Medline Product Number/SKU 64037107
FDA Device · Class I · 2026-05-20 · Medline Industries - BW Webster Duo-Decapolar, Product Number D728260RT
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions - Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
FDA Device · Class II · 2026-05-20 · Edwards Lifesciences - BARD Dynamic Tip Steerable, Product Number 6DYNTP001
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions - Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15
FDA Device · Class II · 2026-05-20 · Ge Medical Systems - Daig Livewire Steerable, Product Number 401575
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions - Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27
FDA Device · Class II · 2026-05-20 · Ge Medical Systems - Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Number: SW13355 Software V…
FDA Device · Class II · 2026-05-20 · Dexcom - Cannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-15322-VSP, CS-15362-VSP, CS-15552-VSP, CSD-15242-SP, CSD-15282-SP
FDA Device · Class I · 2026-05-20 · Arrow International - Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following devices: 1. PROG CT900A C…
FDA Device · Class II · 2026-05-20 · Medtronic Neuromodulation - Brand Name: DONJOY Product Name: ICEMAN CLASSIC CUBE Model/Catalog Number: 11-0494 Software Version: no Product Description: 11-0494 - ICEM…
FDA Device · Class II · 2026-05-20 · Djo - Daig Livewire Steerable, Product Number 401923
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions - Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038402
FDA Device · Class I · 2026-05-20 · Medline Industries - Daig Livewire Steerable, Product Number 401908
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions - Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301
FDA Device · Class I · 2026-05-20 · Medline Industries - 3DIMENSIONS MAMMOGRAPHY SYSTEM
FDA Device · Class II · 2026-05-20 · Hologic - 1. DBD-MTS,3V,MAN,KIT, Medline Kit Number/SKU 60010195
FDA Device · Class I · 2026-05-20 · Medline Industries - Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA Syringes) Angio Pack…
FDA Device · Class I · 2026-05-20 · Windstone Medical Packaging - Namic Preceptor Manifold, custom, Medline Product Number/SKU 64039307
FDA Device · Class I · 2026-05-20 · Medline Industries - Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028, LABEL, STERILE, IVSTATION SYRINGE (40MMX40MM). 2. Part N…
FDA Device · Class I · 2026-05-20 · Omnicell - Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I
FDA Device · Class I · 2026-05-20 · Arrow International - Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,RH Model/Catalog Number: 11-1422 Software Version: no Product Description: 11-1422…
FDA Device · Class II · 2026-05-20 · Djo - Brand Name: DONJOY Product Name: ICEMAN, W/COLDPAD, NS, RH Model/Catalog Number: 11-9099 Software Version: No Product Description: 11-9099…
FDA Device · Class II · 2026-05-20 · Djo - Daig Livewire Steerable, Product Number 401914
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions - Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. MTS,RT,HANDED/LFT,HRT,KIT, Medline Kit Number/SKU 60010508
FDA Device · Class I · 2026-05-20 · Medline Industries - Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets are intended to be used with the Fluid…
FDA Device · Class II · 2026-05-20 · Stryker - BARD Dynamic Deca Steerable, Product Number 201101
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions - Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-VFI, ACS-15232-VFI, ACS-15272-VFI, CS-15192-VFI, CS-15192-VF…
FDA Device · Class I · 2026-05-20 · Arrow International - Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions - ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref
FDA Device · Class II · 2026-05-20 · Aniara Diagnostica - BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions - Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Model/Catalog Number: SW12300 Software Versi…
FDA Device · Class II · 2026-05-20 · Dexcom - On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
FDA Device · Class II · 2026-05-20 · On X Life Technologies - Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25
FDA Device · Class II · 2026-05-20 · Ge Medical Systems - Medtronic Marinr Steerable, Product Number 72402
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions - Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6
FDA Device · Class II · 2026-05-20 · Ge Medical Systems - LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UDI-DI code: 00883873904565 LUCAS 3 Model Number: 99576 Catalog…
FDA Device · Class II · 2026-05-20 · Jolife Ab - Daig Livewire Steerable, Product Number 401915
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions - BARD Dynamic XT Steerable, Product Number 201104
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions - BARD EP XT Steerable, Product Number 200794
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions - Codman CerebroFlo EVD Catheter with Endexo Technology
FDA Device · Class II · 2026-05-20 · Integra Lifesciences Neurosciences - CS Uni-Directional w Auto ID, Product Number D135303
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions - Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions - Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300
FDA Device · Class II · 2026-05-20 · Ge Medical Systems - BARD Dynamic Tip Steerable, Product Number 200131
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions - CS Uni-Directional w Auto ID, Product Number D135304
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions - Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Number: 11-1424 Software Version: No Product Description: 11-1424…
FDA Device · Class II · 2026-05-20 · Djo - Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software V…
FDA Device · Class II · 2026-05-20 · Dexcom - QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp
FDA Device · Class II · 2026-05-20 · Quidel - Medline medical convenience kits, containing Namic Manifold, Labeled as: TAVI, Medline Kit Number/SKU DYNJ904981C
FDA Device · Class I · 2026-05-20 · Medline Industries - Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART CATH PACK-LF, Medline Kit Number/SKU DYNJ36478B
FDA Device · Class I · 2026-05-20 · Medline Industries - LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 214022-CAS/4.0 mm x 22 mm x 18 mm, 214518-C…
FDA Device · Class II · 2026-05-20 · Microvention - SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D, SDM-00001-2D…
FDA Device · Class II · 2026-05-20 · Hologic - BARD EP XT Decapolar Steerable, Product Number 201007
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions - Daig Livewire Steerable, Product Number 401905
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions - Daig Livewire Steerable, Product Number 401904
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions - 1. 3 VALVE MAN KIT, Medline Kit SKU Number: 65101544
FDA Device · Class I · 2026-05-20 · Medline Industries - Daig Livewire Steerable, Product Number 401581
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions - Diowave Laser System, REF: Diowave 250W
FDA Device · Class II · 2026-05-20 · Technological Medical Advancements - NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SFX, CS-15192-SFX, CS-15232-SFX, CS-15272-SFX, CS-15312-SFX,…
FDA Device · Class I · 2026-05-20 · Arrow International - Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20
FDA Device · Class II · 2026-05-20 · Ge Medical Systems
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)