FDA Device recalls
FDA device enforcement reports cover medical devices, from test kits to implants. openFDA publishes them roughly weekly with a Class I, II, or III classification.
The 50 most recent FDA Device recalls are below. Every older recall is listed in its year archive.
Recalls by year
2026 (2,497) · 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)
Recent recalls
- Scout MD, REF MDS05A-01, MDS05C-01, MDS10C-01 Contents: (1) Scout MD Delivery System, Standard for use with the SCOUT MD Surgical Guidance…
FDA Device · Class II · 2026-10-21 · Merit Medical Systems - Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a demineralized bone ma…
FDA Device · Class II · 2026-10-21 · Medtronic Sofamor Danek Usa - JenaValve Trilogy Delivery Catheter, Size 23MM REF: TRILOGY-DC-S
FDA Device · Class II · 2026-10-21 · Jenavalve Technology - Medline surgical convenience kits labeled as: 1) MAIN/LAPAROSCOPY TRANSPLA PACK, Medline product number/SKU DYNJ0656274AC
FDA Device · Class II · 2026-10-21 · Medline Industries - Generic Name: FilmArray¿ Pneumonia Panel plus Generic Name: FilmArray¿ Pneumonia Panel plus Model/Catalog Number: RFIT-ASY-0143 (30 Kit), R…
FDA Device · Class II · 2026-10-21 · Biofire Diagnostics - BD Phoenix Panel NMIC-306
FDA Device · Class II · 2026-10-21 · Becton Dickinson And - Convenience Kits containing CONMED AirSeal Access Ports GENERAL DAVINCI DYNJG901004C LAP CHOLE DYNJ88071 ROBOTIC PACK DYNJ50474F
FDA Device · Class II · 2026-10-21 · Medline Industries - Curaplex Capnography EtCO2/O2 Oral/Nasal Cannula Multipack (10 pk), Item Number 670272-KIT
FDA Device · Class II · 2026-10-21 · Sarnova Hc - JenaValve Trilogy Delivery Catheter, Size 27MM REF: TRILOGY-DC-L
FDA Device · Class II · 2026-10-21 · Jenavalve Technology - IQ200 SPRINT, REF: 700-3322,700-3322RFB, 700-3325, 700-3326, B48997
FDA Device · Class II · 2026-10-21 · Beckman Coulter - RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020116
FDA Device · Class II · 2026-10-21 · Steris - BD Phoenix Panel NMIC-312
FDA Device · Class II · 2026-10-21 · Becton Dickinson And - Medline surgical convenience kits labeled as: 1) NEURO-SPINE BASIN PACK, Medline Product Number/SKU DYNJ80055A
FDA Device · Class II · 2026-10-21 · Medline Industries - NeuroStar Advanced Therapy System
FDA Device · Class II · 2026-10-21 · Neuronetics - Medline surgical convenience kits labeled as: 1) VEIN HARVESTING PACK-LF, Medline product number/SKU DYNJ0826732J
FDA Device · Class II · 2026-10-21 · Medline Industries - Medline surgical convenience kits labeled as: 1) OPEN HEART PACK A &
FDA Device · Class II · 2026-10-21 · Medline Industries - Likorall Overhead Lifts Product Code: 3121001 Product Description: LIKORALL 200 Product Code: 3122005 Product Description: LIKORALL 242 ES,…
FDA Device · Class II · 2026-10-21 · Baxter Healthcare - TS Femoral Prep Tray, Triathlon
FDA Device · Class II · 2026-10-21 · Howmedica Osteonics - Medline surgical convenience kits labeled as: 1) CV BASIN PACK-LF, Medline Product number/SKU DYNJ0538615K
FDA Device · Class II · 2026-10-21 · Medline Industries - Medline surgical convenience kits labeled as: 1) EAR, Medline product number/SKU DYNJ909020B
FDA Device · Class II · 2026-10-21 · Medline Industries - NaviFlex LW Pusher
FDA Device · Class II · 2026-10-21 · Boston Scientific - Medline convenience kit labeled as: FOOT ANKLE. Medline Kit SKU DYNJ65395A
FDA Device · Class II · 2026-10-21 · Medline Industries - Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a demineralized bone ma…
FDA Device · Class II · 2026-10-21 · Medtronic Sofamor Danek Usa - Medline surgical convenience kits labeled as: CABG AUXILIARY PACK, Medline Product Number/SKU DYNJ44925D
FDA Device · Class II · 2026-10-21 · Medline Industries - TS Misc
FDA Device · Class II · 2026-10-21 · Howmedica Osteonics - FORWARD Gunshot Wound Kit
FDA Device · Class II · 2026-10-21 · Integrated Medcraft - Convenience Kits containing CONMED AirSeal Access Ports ADVANCE LAPAROSCOPIC DYNJ911135A CHN GYN ONCOLOGY DYNJ906731M
FDA Device · Class II · 2026-10-21 · Medline Industries - Convenience Kits containing CONMED AirSeal Access Ports CHN GYN ONCOLOGY DYNJ906731K DYNJ906731L DYNJ906731N DAVINCI PROSTATECTOMY DYNJG901…
FDA Device · Class II · 2026-10-21 · Medline Industries - PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18" TF-5, Product Code: N271H
FDA Device · Class II · 2026-10-21 · Ethicon - JenaValve Trilogy Delivery Catheter, Size 25MM REF: TRILOGY-DC-M
FDA Device · Class II · 2026-10-21 · Jenavalve Technology - MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, REF: OPRO-101
FDA Device · Class II · 2026-10-21 · Microgenics - The ABL90 FLEX and ABL90 FLEX PLUS analyzers are intended for use by trained technologists, nurses, physicians and therapists
FDA Device · Class II · 2026-10-21 · Radiometer Medical Aps - Convenience Kits containing CONMED AirSeal Access Ports HERNANDEZ DAVINCI ACC BUNDLE M DYNJ911258 KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116…
FDA Device · Class II · 2026-10-21 · Medline Industries - 1) Product Name AUD OPEN HEART PACK, Medline Kit Number/SKU DYNJ22052I
FDA Device · Class II · 2026-10-21 · Medline Industries - iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm)
FDA Device · Class II · 2026-10-21 · Si Bone - Williams Cystoscopic Injection Needles, used for cystoscopic injection into the urethra, bladder neck, and bladder wall, Reference Part Num…
FDA Device · Class II · 2026-10-21 · Cook - DxU 840m Iris, REF: C76947
FDA Device · Class II · 2026-10-21 · Beckman Coulter - HemoslL AcuStar HIT-lgG(PF-4)
FDA Device · Class I · 2026-10-21 · Instrumentation Laboratory - RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020117
FDA Device · Class II · 2026-10-21 · Steris - IntelePACS, InteleConnect Portal/Tech Portal Versions PACS-5-1-1-R102, PACS-5-2-1-R93, PACS-5-3-1-R83 through R128, PACS-5-4-1-R66 through…
FDA Device · Class II · 2026-10-21 · Intelerad Medical Systems - Generic Name: FilmArray¿ Pneumonia Panel Generic Name: FilmArray¿ Pneumonia Panel Model/Catalog Number: RFIT-ASY-0144 (30 pack), RFIT-ASY-0…
FDA Device · Class II · 2026-10-21 · Biofire Diagnostics - TS Universal Baseplate Finishing Tray, Triathlon
FDA Device · Class II · 2026-10-21 · Howmedica Osteonics - Medline surgical convenience kits labeled as: 1) SPINAL CDS, Medline Product Number/SKU CDS940087AM
FDA Device · Class II · 2026-10-21 · Medline Industries - RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020115
FDA Device · Class II · 2026-10-21 · Steris - REF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mm
FDA Device · Class II · 2026-10-21 · In2bones Usa - LeadCare II Blood Lead Test Kit
FDA Device · Class III · 2026-10-21 · Magellan Diagnostics - Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis
FDA Device · Class II · 2026-10-21 · W L Gore And Associates - Medline surgical convenience kits labeled as: VEIN HARVESTING PACK, Medline product number/SKU DYNJ51845D
FDA Device · Class II · 2026-10-21 · Medline Industries - Brand Name: IOMAX Product Name: IOMAX Cortical Module Model/Catalog Number: 190296-200 UDI-DI code: 00840067100653 Product Description: The…
FDA Device · Class II · 2026-10-21 · Cadwell Industries - Power F2 Powered Fastening System, Power F2, Item No. 0567093 used with Power X2 Stretchers, Power X2, Item No. 0015816 and PowerX2 Premium…
FDA Device · Class II · 2026-10-21 · Ferno Washington