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.
- 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 - Artelon FlexBand Dynamic Matrix Ref: 31057
FDA Device · Class II · 2026-03-18 · International Life Sciences - Penner Pacific Bathing Spa, Model Numbers 361910-1A, 361910-1A, 361910-XA, 361910-2I, 361910-1A, 361910-1, 361910-XI, 361910-1I, 361910-2A,…
FDA Device · Class III · 2026-03-18 · Penner Patient Care - GEM Premier 5000
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory - Penner Pacific Bathing Spa, Model Numbers 360020-1P
FDA Device · Class III · 2026-03-18 · Penner Patient Care - 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 - Penner Pacific Bathing Spa, Model Numbers 360020-1EP
FDA Device · Class III · 2026-03-18 · Penner Patient Care - Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X
FDA Device · Class II · 2026-03-18 · Exactech - Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices
FDA Device · Class I · 2026-03-18 · Trividia Health - Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART, Model Number: DYNJ902487A
FDA Device · Class II · 2026-03-18 · Medline Industries - GEM Premier 5000 PAK, Part No. 00055360004
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory - 10mL Non-Sterile BD Luer-Lok Tip Syringe Only
FDA Device · Class II · 2026-03-18 · Becton Dickinson And - GEM Premier 5000
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
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory - Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1)
FDA Device · Class II · 2026-03-18 · International Life Sciences - Endo-Model Replacement Plateau
FDA Device · Class II · 2026-03-18 · Waldemar Link And Kg Mfg Site - Artelon FlexBand Plus Ref: 41054 & 41057
FDA Device · Class II · 2026-03-18 · International Life Sciences - Penner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2
FDA Device · Class III · 2026-03-18 · Penner Patient Care - GEM Premier 5000 PAK
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory - CLARITY II Laser System
FDA Device · Class II · 2026-03-18 · Lutronic - GEM Premier 5000
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory - Raz-AT (Attendant Tilt) Mobile Shower Commode Chair, Catalog Number Z300 UDI-DI code: (01)00628758003007 Raz-ART (Attendant Rotational Tilt…
FDA Device · Class II · 2026-03-18 · Raz Design - GEM Premier 5000
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory - GEM Premier 5000 PAK
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory - HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes…
FDA Device · Class II · 2026-03-18 · Covidien - 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 - MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010
FDA Device · Class II · 2026-03-18 · Kob - Olympus Single Use Biopsy Valve
FDA Device · Class II · 2026-03-11 · Olympus - CS300 IABP. Software Version CS300 IABP C.01
FDA Device · Class II · 2026-03-11 · Datascope - Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B3050 Software Version: N/A Product Descript…
FDA Device · Class II · 2026-03-11 · B Braun Medical - Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 633012PE, 635018PE, 631516PE, 636016PE,…
FDA Device · Class II · 2026-03-11 · Vascutek - Olympus Single use Biopsy Valve
FDA Device · Class II · 2026-03-11 · Olympus - Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
FDA Device · Class II · 2026-03-11 · Esaote S P A - Impella RP with SmartAssist
FDA Device · Class I · 2026-03-11 · Abiomed - Atellica CH Urine Albumin (UAlb)
FDA Device · Class II · 2026-03-11 · Siemens Healthcare Diagnostics - EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
FDA Device · Class II · 2026-03-11 · Staar Surgical Ag
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)