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.
- 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 - Philips X3-1 Ultrasound Transducer
FDA Device · Class III · 2026-04-01 · Philips Ultrasound - Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: ES-100V3 (device)
FDA Device · Class II · 2026-04-01 · Koven Technology - CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K/A, CENFT15K, CENFT…
FDA Device · Class I · 2026-04-01 · Merit Medical Systems - Philips Mini Multi TEE Ultrasound Transducer
FDA Device · Class III · 2026-04-01 · Philips Ultrasound - Custom Abutment Ti, for Straumann RC, incl
FDA Device · Class II · 2026-04-01 · Straumann Usa - ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, DC21455550/C
FDA Device · Class I · 2026-04-01 · Merit Medical Systems - MICS3 Angled Sagittal Saw Attachment
FDA Device · Class II · 2026-03-25 · Howmedica Osteonics - Artegraft Vascular Graft
FDA Device · Class II · 2026-03-25 · Lemaitre Vascular - Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a device that displays medical images (including mammograms) and dat…
FDA Device · Class II · 2026-03-25 · Ge Medical Systems - Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm
FDA Device · Class II · 2026-03-25 · Convatec - Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: in vitro diagnostic
FDA Device · Class II · 2026-03-25 · Diagnostica Stago - Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that displays medical images (including mammograms) and da…
FDA Device · Class II · 2026-03-25 · Ge Medical Systems - Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays medical images (including mammograms) an…
FDA Device · Class II · 2026-03-25 · Ge Medical Systems - Convatec, EsteemBody Drainable Pouch REF:423657 10-35mm
FDA Device · Class II · 2026-03-25 · Convatec - Brand Name: Welch Allyn, Inc
FDA Device · Class II · 2026-03-25 · Baxter Healthcare - Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No
FDA Device · Class II · 2026-03-25 · Hologic - Battery Charging Station
FDA Device · Class III · 2026-03-25 · Datascope - Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
FDA Device · Class II · 2026-03-25 · Convatec - Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksell Gamma Knife¿ Elekta…
FDA Device · Class II · 2026-03-25 · Elekta - Cub Pediatric Crib, Model FL19H
FDA Device · Class II · 2026-03-25 · Stryker Medical Division - Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product Description: Influenza A/B v…
FDA Device · Class II · 2026-03-25 · Abbott Diagnostics Scarborough - GEM Premier 5000 PAK
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory - Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05
FDA Device · Class II · 2026-03-18 · Exactech - GEM Premier 5000
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory - Endo-Model Replacement Plateau
FDA Device · Class II · 2026-03-18 · Waldemar Link And Kg Mfg Site - Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5850.16/1 Software Version: Not applicable
FDA Device · Class II · 2026-03-18 · Medartis Ag - CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281
FDA Device · Class II · 2026-03-18 · Beckman Coulter Mishima K K - Endo-Model Replacement Plateau
FDA Device · Class II · 2026-03-18 · Waldemar Link And Kg Mfg Site - Endo-Model SL Connection Component incl
FDA Device · Class II · 2026-03-18 · Waldemar Link And Kg Mfg Site - GEM Premier 5000
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory - IBA Proton Therapy System - PROTEUS 235
FDA Device · Class II · 2026-03-18 · Ion Beam Applications - Endo-Model Replacement Plateau
FDA Device · Class II · 2026-03-18 · Waldemar Link And Kg Mfg Site - Endo-Model Replacement Plateau
FDA Device · Class II · 2026-03-18 · Waldemar Link And Kg Mfg Site - Penner Pacific Bathing Spa, Model Numbers 860010-1L
FDA Device · Class III · 2026-03-18 · Penner Patient Care - GEM Premier 5000 PAK
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory - Medline Medcrest Surgical Gowns: MDTGXC4J5XL DBQ-GOWN,SURG,XALT,L4, CRTCL CVR, GRN, 5 MDTGXC4JL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,L MDT…
FDA Device · Class II · 2026-03-18 · Medline Industries - Penner Pacific Bathing Spa, Model Numbers 560010-2L, 560010-XL, 560010-1L, 560010-XL
FDA Device · Class III · 2026-03-18 · Penner Patient Care - GEM Premier 5000 PAK
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory - Medline Surgical Drapes: MDTBTCS6070GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTBTCS6090GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTD…
FDA Device · Class II · 2026-03-18 · Medline Industries - Clearest Strep-A Cassette Test
FDA Device · Class II · 2026-03-18 · Altruan - GEM Premier 5000
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory - Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5750.16/1 Software Version: Not applicable
FDA Device · Class II · 2026-03-18 · Medartis Ag - Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X
FDA Device · Class III · 2026-03-18 · Penner Patient Care - GEM Premier 5000
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory - Brand Name: Bisaf Strep A Self-Test
FDA Device · Class II · 2026-03-18 · Altruan - Wondfo Streptococcal A At-Home Self-Test
FDA Device · Class II · 2026-03-18 · Altruan - Penner Pacific Bathing Spa, Model Numbers 760010-1, 770010-1
FDA Device · Class III · 2026-03-18 · Penner Patient Care - GEM Premier 5000 PAK
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory - Endo-Model SL Connection Component incl
FDA Device · Class II · 2026-03-18 · Waldemar Link And Kg Mfg Site - GEM Premier 5000 PAK
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory - Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices
FDA Device · Class I · 2026-03-18 · Trividia Health - Endo-Model Replacement Plateau
FDA Device · Class II · 2026-03-18 · Waldemar Link And Kg Mfg Site - Penner Pacific Bathing Spa, Model Numbers 360010-2WT, 360010-1, 370000-1W, 360010-1WT, 362010-1, 370000-1WL, 360010-1L, 360010-1W, 360010-X…
FDA Device · Class III · 2026-03-18 · Penner Patient Care - Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, 360030-1CT, 360030-1C, 360030-XC, 3600…
FDA Device · Class III · 2026-03-18 · Penner Patient Care - PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI code: 00721902629013 Catalog Numbe…
FDA Device · Class II · 2026-03-18 · Physio Control - GEM Premier 5000
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory - Endo-Model Replacement Plateau
FDA Device · Class II · 2026-03-18 · Waldemar Link And Kg Mfg Site - EndoVive Safety PEG Kit
FDA Device · Class II · 2026-03-18 · Boston Scientific - GEM Premier 5000 PAK
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory - DxC 700 AU, REF: B86444, B86446
FDA Device · Class II · 2026-03-18 · Beckman Coulter Mishima K K - Endo-Model Replacement Plateau
FDA Device · Class II · 2026-03-18 · Waldemar Link And Kg Mfg Site - Endo-Model Replacement Plateau
FDA Device · Class II · 2026-03-18 · Waldemar Link And Kg Mfg Site - Endo-Model Replacement Plateau
FDA Device · Class II · 2026-03-18 · Waldemar Link And Kg Mfg Site - GEM Premier 5000
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory
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)