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.
- Brand Name: Quantum Rehab Product Name: Q6 Edge 2.0 (ilevel) Model/Catalog Number: Q6 Edge 2.0 (ilevel) Software Version: 2.0.11, new versi…
FDA Device · Class II · 2026-08-12 · Pride Mobility Products - Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 0mm and 4mm Model/Catalog Number: 9323-5310 Software Version: N/A Pr…
FDA Device · Class II · 2026-08-12 · United Orthopedic - Brand Name: COAPTIUM Connect Product Name: COAPTIUM Connect Model/Catalog Number: NCOCO1510 Software Version: N/A Product Description: In s…
FDA Device · Class II · 2026-08-12 · Tissium - Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System
FDA Device · Class II · 2026-08-12 · Innovasis - Brand Name: Quantum Rehab Product Name: Q6 Edge 3 Stretto Model/Catalog Number: Q6 Edge 3 Stretto Software Version: 2.0.11, new version: 2.…
FDA Device · Class II · 2026-08-12 · Pride Mobility Products - Brand Name: Quantum Rehab Product Name: Q6 Edge 4 Model/Catalog Number: Q6 Edge 4 Software Version: 2.0.11, new version: 2.0.13 Product Des…
FDA Device · Class II · 2026-08-12 · Pride Mobility Products - Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475625 Product Description: Intramedullary Bone Saw Blade Assembly 13mm
FDA Device · Class II · 2026-08-12 · Biomet - Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO5010 Software Version: N/A Product Description: In s…
FDA Device · Class II · 2026-08-12 · Tissium - Brand Name: Quantum Rehab Product Name: Quantum 4Front 2 Model/Catalog Number: Quantum 4Front 2 Software Version: 2.0.11, new version: 2.0.…
FDA Device · Class II · 2026-08-12 · Pride Mobility Products - Brand Name: Quantum Rehab Product Name: Q6 Edge 3 Model/Catalog Number: Q6 Edge 3 Software Version: 2.0.11, new version: 2.0.13 Product Des…
FDA Device · Class II · 2026-08-12 · Pride Mobility Products - Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 LC 240cm Box 20
FDA Device · Class II · 2026-08-12 · Boston Scientific - REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the following instruments: - B1018-280 MicroScan autoSCAN-4 Instrument…
FDA Device · Class II · 2026-08-12 · Beckman Coulter - Brand Name: Quantum rehab Product Name: Q6 Edge 2.0 Model/Catalog Number: Q6 Edge 2.0 Software Version: 2.0.11, new version: 2.0.13 Product…
FDA Device · Class II · 2026-08-12 · Pride Mobility Products - Merge PACS, medical imaging diagnostic workstation
FDA Device · Class II · 2026-08-12 · Merge Healthcare - INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500
FDA Device · Class I · 2026-08-12 · Boston Scientific Neuromodulation - STRYKER AHTO TUBE SET WITH TIP PACKAGING, Catalog Number 0250070620
FDA Device · Class II · 2026-08-12 · Stryker - STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING, Catalog Number 0250070640
FDA Device · Class II · 2026-08-12 · Stryker - Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2010 Software Version: N/A Product Description: In s…
FDA Device · Class II · 2026-08-12 · Tissium - Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL
FDA Device · Class III · 2026-08-12 · Siemens Healthcare Diagnostics - Happiest Baby, Inc Pre-loved SNOO Smart Sleeper Model:S1000
FDA Device · Class II · 2026-08-12 · Happiest Baby - Merge OrthoPACS, medical imaging diagnostic workstation
FDA Device · Class II · 2026-08-12 · Merge Healthcare - Brand Name: Quantum Rehab Product Name: Quantum Rival Model/Catalog Number: Quantum Rival Software Version: 2.0.11, new version: 2.0.13 Pro…
FDA Device · Class II · 2026-08-12 · Pride Mobility Products - Charger for the Therabody Theragun, G4 PRO massage device, and products which include the 4th Generation Theragun PRO charger
FDA Device · Class II · 2026-08-12 · Therabody - 5-PLASMA Bivalirudin Control, Model Number 5D-44905
FDA Device · Class II · 2026-08-12 · Aniara Diagnostica - Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO3010 Software Version: N/A Product Description: In s…
FDA Device · Class II · 2026-08-12 · Tissium - Brand Name: Quantum Rehab Product Name: R-TRAK Model/Catalog Number: R-TRAK Software Version: 2.0.11, new version: 2.0.13 Product Descripti…
FDA Device · Class II · 2026-08-12 · Pride Mobility Products - Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF
FDA Device · Class II · 2026-08-12 · Freudenberg Medical - FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The FilmArray NGDS Warrior Panel is a qualitative, multiplex…
FDA Device · Class II · 2026-08-12 · Biofire Defense - Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO1575 Software Version: N/A Product Description: In s…
FDA Device · Class II · 2026-08-12 · Tissium - Nerivio Infinity
FDA Device · Class II · 2026-08-12 · Theranica Bioelectronics - Philips Allura under the following System Descriptions and corresponding model numbers: 1. Allura Xper FD10
FDA Device · Class II · 2026-08-12 · Philips Medical Systems Nederland B V - Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 SC 240cm Box 20
FDA Device · Class II · 2026-08-12 · Boston Scientific - Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF
FDA Device · Class II · 2026-08-12 · Freudenberg Medical - Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product Description: Intramedullary Bone Saw Blade Assembly 12mm
FDA Device · Class II · 2026-08-12 · Biomet - Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475640 Product Description: Intramedullary Bone Saw Blade Assembly 16mm
FDA Device · Class II · 2026-08-12 · Biomet - Brand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left and Femoral valgus offset adaptor, 2mm, 4…
FDA Device · Class II · 2026-08-12 · United Orthopedic - Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO6010 Software Version: N/A Product Description: In s…
FDA Device · Class II · 2026-08-12 · Tissium - Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product Description: Intramedullary Bone Saw Blade Assembly 15mm
FDA Device · Class II · 2026-08-12 · Biomet - Brand Name: OXOS Medical, Inc Product Name: MC2 Portable X-Ray System Model/Catalog Number: MC2, MC2.1 Software Version: 5.7.0 Product Desc…
FDA Device · Class II · 2026-08-12 · Oxos Medical - Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2 Product…
FDA Device · Class II · 2026-08-12 · Nuclein - STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600
FDA Device · Class II · 2026-08-12 · Stryker - munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smart Glasses Interface/Wheelchair Head Control System
FDA Device · Class II · 2026-08-12 · Munevo - GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 00077415008 00077415010 00077430010 Product Description: The G…
FDA Device · Class II · 2026-08-12 · Instrumentation Laboratory - 5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905
FDA Device · Class II · 2026-08-12 · Aniara Diagnostica - Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475630 Product Description: Intramedullary Bone Saw Blade Assembly 14mm
FDA Device · Class II · 2026-08-12 · Biomet - Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 2mm and 6mm Model/Catalog Number: 9323-5312 Software Version: N/A Pr…
FDA Device · Class II · 2026-08-12 · United Orthopedic - Brand Name: Quantum Rehab Product Name: Quantum 4Front 2HD Model/Catalog Number: Quantum 4Front 2HD Software Version: 2.0.11, new version:…
FDA Device · Class II · 2026-08-12 · Pride Mobility Products - Brand Name: USTAR II Knee System Product Name: Hinge Box Trial, L, #1-6 and Hinge Box Trial, R, #1-6 Model/Catalog Number: 9325-5711 thru 9…
FDA Device · Class II · 2026-08-12 · United Orthopedic - REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the following instruments: - B1018-280 MicroScan autoSCA…
FDA Device · Class II · 2026-08-12 · Beckman Coulter - GE Healthcare MAC VU360, REF# part number 2030361-023
FDA Device · Class II · 2026-08-12 · Ge Medical Systems Information Technologies - Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number: 9323-5511 thru 9323-…
FDA Device · Class II · 2026-08-12 · United Orthopedic - Philips Azurion under the following System Descriptions and corresponding model numbers: 1. Azurion 3 M12
FDA Device · Class II · 2026-08-12 · Philips Medical Systems Nederland B V - Brand Name: Quantum Rehab Product Name: Quantum 1450 Model/Catalog Number: Quantum 1450 Software Version: 2.0.11, new version: 2.0.13 Produ…
FDA Device · Class II · 2026-08-12 · Pride Mobility Products - STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540
FDA Device · Class II · 2026-08-12 · Stryker - Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2075 Software Version: N/A Product Description: In s…
FDA Device · Class II · 2026-08-12 · Tissium - Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds
FDA Device · Class I · 2026-08-12 · Avid Medical - REMISOL Advance with Software Version 2.5 UDI-DI code: 15099590802073 The Normand Info REMISOL Advance Data Manager collects and manages da…
FDA Device · Class II · 2026-08-12 · Beckman Coulter Biomedical - Brand Name: Quantum Rehab Product Name: 4Front Model/Catalog Number: 4Front Software Version: 2.0.11, new version: 2.0.13 Product Descripti…
FDA Device · Class II · 2026-08-12 · Pride Mobility Products - Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF: NG-06…
FDA Device · Class II · 2026-08-12 · Contego Medical - Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4 Jumbo 240cm Box 5
FDA Device · Class II · 2026-08-12 · Boston Scientific - Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds
FDA Device · Class I · 2026-08-12 · Avid Medical - FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12)
FDA Device · Class II · 2026-08-12 · Integrated Medcraft - Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO4010 Software Version: N/A Product Description: In s…
FDA Device · Class II · 2026-08-12 · Tissium - 5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905
FDA Device · Class II · 2026-08-12 · Aniara Diagnostica - 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
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)