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.
- 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 - 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
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)