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.
- Cardinal Health Presource Kits: 1) KIT, MER NEURO BACK , Catalog Number: PN33NBMYD
FDA Device · Class II · 2026-08-19 · Cardinal Health 200 - Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Number: 21-4720B
FDA Device · Class II · 2026-08-19 · Cardinal Health 200 - Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16
FDA Device · Class II · 2026-08-19 · Waldemar Link And Kg Mfg Site - Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058
FDA Device · Class II · 2026-08-19 · Philips Medical Systems Nederland B V - Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMB
FDA Device · Class II · 2026-08-19 · Cardinal Health 200 - GM Helix Implant, Endosseous Dental Implant Article No. 109.984
FDA Device · Class II · 2026-08-19 · Straumann Usa - Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507
FDA Device · Class I · 2026-08-19 · Baxter Healthcare - Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314)
FDA Device · Class II · 2026-08-19 · Straumann Usa - BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic
FDA Device · Class II · 2026-08-19 · Biofire Diagnostics - Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version Numbers: R3.0 and…
FDA Device · Class II · 2026-08-19 · Philips Medical Systems Nederland B V - Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC27
FDA Device · Class II · 2026-08-19 · Cardinal Health 200 - 60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 MaxPlus Ext Set w/Needleless and Y-Site REF MPX5305-C UDI-DI c…
FDA Device · Class II · 2026-08-19 · Bd Switzerland Sarl - Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-03) Sheath with Dilator , Stiffen Dilator, Nitinol…
FDA Device · Class II · 2026-08-19 · Galt Medical - ProNephro AKI (NGAL) Reagent Kit (100 tests)
FDA Device · Class II · 2026-08-19 · Bioporto Diagnostics A S - Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0 BLU 75CM C14 88861799-31
FDA Device · Class II · 2026-08-19 · Covidien - Medline Micro-Kill Bleach Germicidal Bleach Wipes,7" x 8", 150 count, 150 count, Product Number MSC351400AN
FDA Device · Class II · 2026-08-19 · Medline Industries - Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalog Number: AMPUL10ML…
FDA Device · Class I · 2026-08-19 · Spectra Medical Devices - Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, 722225, 722226, 72222…
FDA Device · Class II · 2026-08-19 · Philips Medical Systems Nederland B V - Cardinal Health Presource Kits: 1) SEPTO RHINO PACK , Catalog Number: SEN73NSKCF
FDA Device · Class II · 2026-08-19 · Cardinal Health 200 - Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX
FDA Device · Class II · 2026-08-19 · Covidien - Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC
FDA Device · Class II · 2026-08-19 · Cardinal Health 200 - Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count, Product Number MSC351450AN
FDA Device · Class II · 2026-08-19 · Medline Industries - ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000
FDA Device · Class II · 2026-08-19 · Erbe Usa - GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box
FDA Device · Class II · 2026-08-19 · Terumo Medical - OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF: C020130-1
FDA Device · Class II · 2026-08-19 · Obp Medical - GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010
FDA Device · Class II · 2026-08-19 · W L Gore And Associates - GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006
FDA Device · Class II · 2026-08-19 · W L Gore And Associates - Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623
FDA Device · Class II · 2026-08-19 · Covidien - Medline Micro-Kill Bleach Germicidal Bleach Wipes, 6" x 5", 150 count, Product Number MSC351410AN
FDA Device · Class II · 2026-08-19 · Medline Industries - Brand Name: Medical Action Industries Product Name: Dialysis Change Tray Clear Sequence Model/Catalog Number: 78791
FDA Device · Class II · 2026-08-12 · Medical Action Industries 306 - STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530
FDA Device · Class II · 2026-08-12 · Stryker - Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalog Number: 9323-5333 and 9323-5334 Softwar…
FDA Device · Class II · 2026-08-12 · United Orthopedic - GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitoring system
FDA Device · Class II · 2026-08-12 · Ge Medical Systems Information Technologies - Brand Name: Quantum Rehab Product Name: Quantum Outback Model/Catalog Number: Quantum Outback Software Version: 2.0.11, new version: 2.0.13…
FDA Device · Class II · 2026-08-12 · Pride Mobility Products - GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 00055445010 00055445011 00055360…
FDA Device · Class II · 2026-08-12 · Instrumentation Laboratory - HardyDisk AST Cefiderocol 30¿g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30¿g (FDC30) for in vitro agar diffusion susceptibility testing…
FDA Device · Class II · 2026-08-12 · Hardy Diagnostics - 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
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)