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.
- 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 - Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. ANGIOGRAPHY CATH LAB, Medline Kit Number/SKUDYNJ23532C
FDA Device · Class I · 2026-05-20 · Medline Industries - Daig Livewire Steerable, Product Number 401932
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions - Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number:DYNJ56436A
FDA Device · Class II · 2026-05-13 · Medline Industries - Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I
FDA Device · Class II · 2026-05-13 · Medline Industries - Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A
FDA Device · Class II · 2026-05-13 · Medline Industries - Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B
FDA Device · Class II · 2026-05-13 · Medline Industries - Halyard VA DETROIT CATH LAB PACK kit
FDA Device · Class I · 2026-05-13 · Avid Medical - See RES for complete list
FDA Device · Class II · 2026-05-13 · Medline Industries - Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN, Model Number:PAIN0150C
FDA Device · Class II · 2026-05-13 · Medline Industries - Medline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185
FDA Device · Class II · 2026-05-13 · Medline Industries - VOCSN V+Pro package, REF: PRT-01198-000
FDA Device · Class I · 2026-05-13 · Ventec Life Systems - Medline Convenience Kits: 1) ARTHROSCOPY CDS, Model Number: CDS984609B
FDA Device · Class II · 2026-05-13 · Medline Industries - Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 Sizing catheters are single-use, sterile catheters with go…
FDA Device · Class I · 2026-05-13 · Cook - Medline Convenience Kits: 1) KIT UROLOGY SLING, Model Number: DYKMBNDL106
FDA Device · Class II · 2026-05-13 · Medline Industries - Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326
FDA Device · Class II · 2026-05-13 · Medline Industries - DEX Ophthalmic Tissue Forceps, 23ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-23
FDA Device · Class II · 2026-05-13 · Katalyst Surgical - DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-25-S
FDA Device · Class II · 2026-05-13 · Katalyst Surgical - See RES for complete list
FDA Device · Class II · 2026-05-13 · Medline Industries - LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW…
FDA Device · Class II · 2026-05-13 · Boston Scientific - QUCARE Total Cholesterol in vitro diagnostic test REF: 6407
FDA Device · Class II · 2026-05-13 · Dfi - DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-25-S
FDA Device · Class II · 2026-05-13 · Katalyst Surgical - DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27
FDA Device · Class II · 2026-05-13 · Katalyst Surgical - Medline Convenience Kits: 1) CHEST TUBE INSERTION TRAY, Model Number: DYNDA2941A
FDA Device · Class II · 2026-05-13 · Medline Industries - Halyard CATH LAB kit
FDA Device · Class I · 2026-05-13 · Avid Medical - Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000
FDA Device · Class II · 2026-05-13 · Intuitive Surgical - Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement
FDA Device · Class II · 2026-05-13 · Centinel Spine - One Step pH in vitro diagnostic test REF: 31I4P
FDA Device · Class II · 2026-05-13 · Dfi - Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures are available in a vari…
FDA Device · Class I · 2026-05-13 · Cook - Medline Convenience Kits: 1) CVC PACK, Model Number: CVI4500A
FDA Device · Class II · 2026-05-13 · Medline Industries - Halyard CARDIAC CATH PACK kit
FDA Device · Class I · 2026-05-13 · Avid Medical - Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806L
FDA Device · Class II · 2026-05-13 · Medline Industries - Halyard NEURO IR PERIPHERAL (PS 64405) kit
FDA Device · Class I · 2026-05-13 · Avid Medical - BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit
FDA Device · Class II · 2026-05-13 · Biofire Diagnostics - DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Serrated Forceps, Model/Catalog Number: DVF4016-25-S
FDA Device · Class II · 2026-05-13 · Katalyst Surgical - Uric Acid in vitro diagnostic test REF: 31H0P
FDA Device · Class II · 2026-05-13 · Dfi - Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement
FDA Device · Class II · 2026-05-13 · Centinel Spine
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)