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.
- Atellica CH Enzymatic Hemoglobin A1c (A1c_E)
FDA Device · Class II · 2026-04-08 · Siemens Healthcare Diagnostics - Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar Curved Scissors Instrument Model/…
FDA Device · Class II · 2026-04-08 · Intuitive Surgical - Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/Catalog Number: TFL-P…
FDA Device · Class II · 2026-04-08 · Olympus - MiniMed 700G Insulin Pump (MMT-1801, MMT-1805, MMT-1850, MMT-1851)
FDA Device · Class II · 2026-04-08 · Medtronic Minimed - MiniMed 670G Insulin Pump (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782)
FDA Device · Class II · 2026-04-08 · Medtronic Minimed - ALLURA Xper FD20 OR Table
FDA Device · Class II · 2026-04-08 · Philips Medical Systems Nederland B V - OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests
FDA Device · Class II · 2026-04-08 · Oxoid Australia - Medline kits containing Olympus biopsy valves: 1. BAL KIT, DYNDA2137B 2. ENDO KIT, DYKE1915
FDA Device · Class II · 2026-04-08 · Medline Industries - Burlington Medical, Blockers
FDA Device · Class II · 2026-04-08 · Burlington Medical - eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152
FDA Device · Class II · 2026-04-08 · Civco Medical Instruments - MiniMed 770G Insulin Pump (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)
FDA Device · Class II · 2026-04-08 · Medtronic Minimed - Allura Xper FD20/20 OR Table
FDA Device · Class II · 2026-04-08 · Philips Medical Systems Nederland B V - Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011
FDA Device · Class II · 2026-04-08 · Ultradent Products - MiniMed 740G Insulin Pump (MMT-1811, MMT-1812, MMT-1861, MMT-1862)
FDA Device · Class II · 2026-04-08 · Medtronic Minimed - ALLURA Xper FD20 Biplane
FDA Device · Class II · 2026-04-08 · Philips Medical Systems Nederland B V - Purge Cassette, sold within Impella Pump Sets and Individually Packaged
FDA Device · Class I · 2026-04-08 · Abiomed - Burlington Medical, Thyroid Shield
FDA Device · Class II · 2026-04-08 · Burlington Medical - Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si Permanent Cautery Hook Instrument Model/Catalog N…
FDA Device · Class II · 2026-04-08 · Intuitive Surgical - ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC
FDA Device · Class II · 2026-04-08 · Medline Industries - CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissue Expander Style (9…
FDA Device · Class II · 2026-04-08 · Mentor Texas - Azurion 3 M15
FDA Device · Class II · 2026-04-08 · Philips Medical Systems Nederland B V - Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si Mega Needle Driver Instrument Model/Catalog Number: 4…
FDA Device · Class II · 2026-04-08 · Intuitive Surgical - MEDLINE ANTERIOR HIP PACK DYNJ64672B
FDA Device · Class II · 2026-04-08 · Medline Industries - ALLURA Xper FD10/10
FDA Device · Class II · 2026-04-08 · Philips Medical Systems Nederland B V - Allura Xper FD20/20
FDA Device · Class II · 2026-04-08 · Philips Medical Systems Nederland B V - Allura Xper FD20/15 OR Table
FDA Device · Class II · 2026-04-08 · Philips Medical Systems Nederland B V - Medline kits containing Olympus biopsy valves: 1. BRONCHOSCOPY, DYNJ900898I DYNJ901922G 2. FLEXIBLE BRONCHOSCOPY KIT, DYKM1417I DYKM1417J 3…
FDA Device · Class II · 2026-04-08 · Medline Industries - ALLURA Xper FD20
FDA Device · Class II · 2026-04-08 · Philips Medical Systems Nederland B V - Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135UH SDC-140UH Smooth Ultra High Profile Ti…
FDA Device · Class II · 2026-04-08 · Mentor Texas - eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159
FDA Device · Class II · 2026-04-08 · Civco Medical Instruments - CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-107MH, SCPX-117MH,SCPX-127MH, SCPX-135MH, SCPX-146MH, SCPX-156MH…
FDA Device · Class II · 2026-04-08 · Mentor Texas - THORACIC ROBOTS, DYNJ908777B
FDA Device · Class II · 2026-04-08 · Medline Industries - Airway Exam Kit, DYKE1796
FDA Device · Class II · 2026-04-08 · Medline Industries - Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci S, Si Grasping Retractor Instrument Model/Catalog Number: 4…
FDA Device · Class II · 2026-04-08 · Intuitive Surgical - ALLURA Xper FD10
FDA Device · Class II · 2026-04-08 · Philips Medical Systems Nederland B V - Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00
FDA Device · Class I · 2026-04-08 · Philips Respironics - Burlington Medical, Vest
FDA Device · Class II · 2026-04-08 · Burlington Medical - Medline kits containing Olympus biopsy valves: 1. BRONCH PROCEDURE KIT, DYKE2091 2. BRONCHSCOPY, DYNJ900898G DYNJ901922I 3. BRONCHSCOPY PAC…
FDA Device · Class II · 2026-04-08 · Medline Industries - MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
FDA Device · Class II · 2026-04-08 · Medtronic Minimed - eTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156
FDA Device · Class II · 2026-04-08 · Civco Medical Instruments - Handy Solutions Neck & Shoulders Heating Pad, Number: 25607, Manufactured by Ninbo Unico Products Co., Ltd
FDA Device · Class I · 2026-04-01 · Navajo Manufacturing - Olympus Endoscope Air/Water Valve - MAJ-1444
FDA Device · Class II · 2026-04-01 · Olympus - Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILE EO. For surgical use
FDA Device · Class I · 2026-04-01 · Erbe Usa - Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410
FDA Device · Class I · 2026-04-01 · Erbe Usa - HLS - Hand Locking Plates System with the below descriptions and corresponding article numbers. 1. Cortical Screw
FDA Device · Class II · 2026-04-01 · I T S - MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61
FDA Device · Class II · 2026-04-01 · Medtronic Minimed - I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the below descriptions and corresponding article numbe…
FDA Device · Class II · 2026-04-01 · I T S - Embrace Drill Tower, Standard/Lateral (25mm)
FDA Device · Class II · 2026-04-01 · Waldemar Link And Kg Mfg Site - Philips C9-4 Ultrasound Transducer
FDA Device · Class III · 2026-04-01 · Philips Ultrasound - DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H787103028035/A, H787103028041/A, H787103028…
FDA Device · Class I · 2026-04-01 · Merit Medical Systems - HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated
FDA Device · Class II · 2026-04-01 · I T S - Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog Number: PK-CF0533 Product Description: An a…
FDA Device · Class II · 2026-04-01 · Olympus - Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920000PK Product Descripti…
FDA Device · Class II · 2026-04-01 · Olympus - Olecranonplate with Angular Stability with the below descriptions and corresponding article numbers. 1. Olecranon Hook Plate
FDA Device · Class II · 2026-04-01 · I T S - FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptions and corresponding article numbers. 1.…
FDA Device · Class II · 2026-04-01 · I T S - Philips X7-2 Ultrasound Transducer
FDA Device · Class III · 2026-04-01 · Philips Ultrasound - Philips L17-5 Ultrasound Transducer
FDA Device · Class III · 2026-04-01 · Philips Ultrasound - Custom Abutment AS Ti, for Straumann RC, incl
FDA Device · Class II · 2026-04-01 · Straumann Usa - Distal Humeral Plates with Angular Stability with the below descriptions and corresponding article numbers. 1. Cortical Screw, Locking
FDA Device · Class II · 2026-04-01 · I T S - Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920005PK Product Description: The…
FDA Device · Class II · 2026-04-01 · Olympus - Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP
FDA Device · Class II · 2026-04-01 · Ge Medical Systems - Philips OMNI III TEE Ultrasound Transducer
FDA Device · Class III · 2026-04-01 · Philips Ultrasound - Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3…
FDA Device · Class II · 2026-04-01 · Olympus - Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery Sy…
FDA Device · Class II · 2026-04-01 · Amo Puerto Rico Manufacturing - Drill Plate, Ortho Dev
FDA Device · Class II · 2026-04-01 · Orthalign - 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B
FDA Device · Class I · 2026-04-01 · Merit Medical Systems - FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate
FDA Device · Class II · 2026-04-01 · I T S - Brand Name: Humeral Head Plate with Angular Stability, with the following description: Proximal Humeral Plate
FDA Device · Class II · 2026-04-01 · I T S - Philips S4-1 Ultrasound Transducer
FDA Device · Class III · 2026-04-01 · Philips Ultrasound - Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 21031-3, 21031-5, 21032…
FDA Device · Class II · 2026-04-01 · I T S - Philips 3D6-2 Ultrasound Transducer
FDA Device · Class III · 2026-04-01 · Philips Ultrasound - Philips L12-5 Ultrasound Transducer
FDA Device · Class III · 2026-04-01 · Philips Ultrasound - Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP DRESSING,COLLAGEN,PURACOL PLUS,…
FDA Device · Class II · 2026-04-01 · Medline Industries - Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers. 1. Fixation Screw
FDA Device · Class II · 2026-04-01 · I T S - Olympus Endoscope Reprocessor OER-Pro
FDA Device · Class II · 2026-04-01 · Olympus - BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU, H965103028041/A, H9651…
FDA Device · Class I · 2026-04-01 · Merit Medical Systems - Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forceps Model/Catalog Number: HACF0533 Product Descri…
FDA Device · Class II · 2026-04-01 · Olympus - MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for use in determining antimicrobial agent suscep…
FDA Device · Class II · 2026-04-01 · Beckman Coulter - BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
FDA Device · Class II · 2026-04-01 · Carefusion 303 - Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00
FDA Device · Class I · 2026-04-01 · Philips Respironics - I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article numbers. 1. Forearm Plate, Curved
FDA Device · Class II · 2026-04-01 · I T S - I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article numbers. 1. DFL (Distal Femur Locking) Dis…
FDA Device · Class II · 2026-04-01 · I T S - Philips Respironics Trilogy EV300, Software Version 1.05.15.00
FDA Device · Class I · 2026-04-01 · Philips Respironics - Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411
FDA Device · Class I · 2026-04-01 · Erbe Usa - Philips S5-2 Ultrasound Transducer
FDA Device · Class III · 2026-04-01 · Philips Ultrasound - I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers. 1. Distal Tubular Plate
FDA Device · Class II · 2026-04-01 · I T S - Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 3005PK Product Description: The P…
FDA Device · Class II · 2026-04-01 · Olympus - Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3005 Pr…
FDA Device · Class II · 2026-04-01 · Olympus - Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin
FDA Device · Class II · 2026-04-01 · Tandem Diabetes Care - I.T.S. Screw System with the below descriptions and corresponding article numbers. 1. Cancellous Screw, Cannulated
FDA Device · Class II · 2026-04-01 · I T S - Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00
FDA Device · Class I · 2026-04-01 · Philips Respironics - Olympus Endoscope Suction Valve - MAJ-1443
FDA Device · Class II · 2026-04-01 · Olympus - Pilonplate with Angular Stability, with the below descriptions and corresponding article numbers. 1. Anterolateral Tibia Plate
FDA Device · Class II · 2026-04-01 · I T S - Brand Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) with the below descriptions and corresponding article numbers. 1. An…
FDA Device · Class II · 2026-04-01 · I T S - Philips OMNI II TEE Ultrasound Transducer
FDA Device · Class III · 2026-04-01 · Philips Ultrasound - Olympus Endoscope Reprocessor OER-Elite
FDA Device · Class II · 2026-04-01 · Olympus - Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. 1. Anterior Clavicle Plate, Medial
FDA Device · Class II · 2026-04-01 · I T S - Philips Respironics Trilogy Evo, Software Version 1.05.15.00
FDA Device · Class I · 2026-04-01 · Philips Respironics - Embrace Drill Tower, Wedged (25mm)
FDA Device · Class II · 2026-04-01 · Waldemar Link And Kg Mfg Site - Drill Plate, Ortho Dev
FDA Device · Class II · 2026-04-01 · Orthalign
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)