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.
- Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722)
FDA Device · Class II · 2026-04-08 · Medtronic Minimed - Paradigm Insulin Pump (MMT-712, MMT-715)
FDA Device · Class II · 2026-04-08 · Medtronic Minimed - Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFL-SLS Model/Catalog Number: TFL-SLS conta…
FDA Device · Class II · 2026-04-08 · Olympus - ALLURA Xper FD10 OR Table
FDA Device · Class II · 2026-04-08 · Philips Medical Systems Nederland B V - eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150
FDA Device · Class II · 2026-04-08 · Civco Medical Instruments - Allura Xper FD20/15
FDA Device · Class II · 2026-04-08 · Philips Medical Systems Nederland B V - BD Kiestra" ReadA
FDA Device · Class II · 2026-04-08 · Bd Kiestra Lab Automation - Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135RH TEXP140RH TEXP150RH Textured, High &…
FDA Device · Class II · 2026-04-08 · Mentor Texas - Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, CA
FDA Device · Class I · 2026-04-08 · Abiomed - Azurion 7 B20
FDA Device · Class II · 2026-04-08 · Philips Medical Systems Nederland B V - Medline convenience kits containing Olympus biopsy valves: 1. BRONCH PACK, DYKE2096 2. NON MB BRONCHOPSCOPY CCH LH PK, DYNJT6182 3. PULMONA…
FDA Device · Class II · 2026-04-08 · Medline Industries - CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650cc
FDA Device · Class II · 2026-04-08 · Mentor Texas - Allura Xper FD10C
FDA Device · Class II · 2026-04-08 · Philips Medical Systems Nederland B V - Azurion 7 M20
FDA Device · Class II · 2026-04-08 · Philips Medical Systems Nederland B V - Burlington Medical, BAT (Breast, Axilla and Thyroid) Coverage
FDA Device · Class II · 2026-04-08 · Burlington Medical - MiniMed 780G Insulin Pump (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896)
FDA Device · Class II · 2026-04-08 · Medtronic Minimed - Sterile Radiology Procedure Kits, Model Number DYNDH1491B
FDA Device · Class II · 2026-04-08 · Medline Industries - RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
FDA Device · Class II · 2026-04-08 · Reflexion Medical - Philips Respironics Trilogy EV300, Software Version 1.05.15.00
FDA Device · Class I · 2026-04-08 · Philips Respironics - Azurion 5 M20
FDA Device · Class II · 2026-04-08 · Philips Medical Systems Nederland B V - Medline Kits containing ENFIT G-TUBE CONNECTOR 1. SKU DYKM2720 G/J TUBE CARE KIT 2. SKU ENFITDISCKIT ENFIT DISCHARGE KIT
FDA Device · Class II · 2026-04-08 · Medline Industries - Burlington Medical, Half Aprons
FDA Device · Class II · 2026-04-08 · Burlington Medical - Azurion 7 B12
FDA Device · Class II · 2026-04-08 · Philips Medical Systems Nederland B V - Azurion 3 M12
FDA Device · Class II · 2026-04-08 · Philips Medical Systems Nederland B V - Azurion 5 M12
FDA Device · Class II · 2026-04-08 · Philips Medical Systems Nederland B V - Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci S, Si Tenaculum Forceps Instrument Model/Catalog Number: 420…
FDA Device · Class II · 2026-04-08 · Intuitive Surgical - Burlington Medical, Demi Half Aprons
FDA Device · Class II · 2026-04-08 · Burlington Medical - CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-113TH, SCPX-123TH, SCPX-140TH, SCPX-146TH Smooth Tall Height Tiss…
FDA Device · Class II · 2026-04-08 · Mentor Texas - Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001
FDA Device · Class II · 2026-04-08 · Stryker Communications - ALLURA Xper FD10F
FDA Device · Class II · 2026-04-08 · Philips Medical Systems Nederland B V - Allura Xper FD20/10
FDA Device · Class II · 2026-04-08 · Philips Medical Systems Nederland B V - Burlington Medical, Wrap Aprons
FDA Device · Class II · 2026-04-08 · Burlington Medical - eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151
FDA Device · Class II · 2026-04-08 · Civco Medical Instruments - Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS-068-02 Product Descr…
FDA Device · Class II · 2026-04-08 · Recor Medical - Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H SDC-130H SDC-135H SDC-140H SDC-150H SDC-155H Smooth High Prof…
FDA Device · Class II · 2026-04-08 · Mentor Texas - 2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US
FDA Device · Class II · 2026-04-08 · Synthes Usa Products - 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
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)