FDA Device · 2025

FDA Device recalls in 2025

RecallRadar indexes 2,908 FDA Device recall notices published in 2025. By classification: 380 Class I, 2,433 Class II, 95 Class III.

• AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) SFCH CRANI PACK (PS 132432), MODEL/ITEM NUMBER UICR10W
  FDA Device · Class II · 2025-09-03 · American Contract Systems
• Orascoptic Superior Visualization Phantom Nose Pad Accessory Kit ( nose pad and screw) 1 pk. and 20 pk
  FDA Device · Class II · 2025-09-03 · Orascoptic Surgical Acuity
• AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL KIT, Model/Item Number LLBN11C
  FDA Device · Class II · 2025-09-03 · American Contract Systems
• STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Sat…
  FDA Device · Class II · 2025-09-03 · Diagnostica Stago
• L15-7io Transducer Probe
  FDA Device · Class III · 2025-09-03 · Philips Ultrasound
• C8-5 Transducer Probe
  FDA Device · Class III · 2025-09-03 · Philips Ultrasound
• S4-1 Transducer Probe
  FDA Device · Class III · 2025-09-03 · Philips Ultrasound
• VL13-5 Transducer Probe
  FDA Device · Class III · 2025-09-03 · Philips Ultrasound
• PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724
  FDA Device · Class II · 2025-09-03 · Vantive Us Healthcare
• Orascoptic Superior Visualization Custom loupes configured with Phantom Frames
  FDA Device · Class II · 2025-09-03 · Orascoptic Surgical Acuity
• V6-2 Transducer Probe
  FDA Device · Class III · 2025-09-03 · Philips Ultrasound
• C5-2 Lumify Transducer Probe
  FDA Device · Class III · 2025-09-03 · Philips Ultrasound
• S4-2 Transducer Probe
  FDA Device · Class III · 2025-09-03 · Philips Ultrasound
• D2cwc Transducer Probe
  FDA Device · Class III · 2025-09-03 · Philips Ultrasound
• X7-2 Transducer Probe
  FDA Device · Class III · 2025-09-03 · Philips Ultrasound
• Transducer C10-3v Transducer Probe
  FDA Device · Class III · 2025-09-03 · Philips Ultrasound
• X5-1c Transducer Probe
  FDA Device · Class III · 2025-09-03 · Philips Ultrasound
• 3D9-3v Transducer Probe
  FDA Device · Class III · 2025-09-03 · Philips Ultrasound
• Brand Name: THOR Product Name: NovoTHOR Model/Catalog Number: S2188 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL…
  FDA Device · Class II · 2025-09-03 · Thor Photomedicine
• TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631
  FDA Device · Class II · 2025-09-03 · Vantive Us Healthcare
• PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701
  FDA Device · Class II · 2025-09-03 · Vantive Us Healthcare
• L12-4 Lumify Transducer Probe
  FDA Device · Class III · 2025-09-03 · Philips Ultrasound
• GE HealthCare OEC 9800
  FDA Device · Class II · 2025-09-03 · Ge Medical Systems
• AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH40N
  FDA Device · Class II · 2025-09-03 · American Contract Systems
• Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: CDS984076J GYN ROBOTIC DYNJG001004A LAVH MINOR DYNJG901001B CRANIO…
  FDA Device · Class II · 2025-09-03 · Medline Industries Northfield
• C6-2 Transducer Probe
  FDA Device · Class III · 2025-09-03 · Philips Ultrasound
• L12-5 50 Transducer Probe
  FDA Device · Class III · 2025-09-03 · Philips Ultrasound
• Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2189 Software Version: N/A Product Description: The NovoTHOR…
  FDA Device · Class II · 2025-09-03 · Thor Photomedicine
• L18-5 Transducer Probe
  FDA Device · Class III · 2025-09-03 · Philips Ultrasound
• IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834
  FDA Device · Class II · 2025-09-03 · Medtronic Xomed
• Orascoptic Superior Visualization Phantom Essential kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdrive…
  FDA Device · Class II · 2025-09-03 · Orascoptic Surgical Acuity
• C9-4 Transducer Probe
  FDA Device · Class III · 2025-09-03 · Philips Ultrasound
• C10-4ec Transducer Probe
  FDA Device · Class III · 2025-09-03 · Philips Ultrasound
• C9-3v Transducer Probe
  FDA Device · Class III · 2025-09-03 · Philips Ultrasound
• Orascoptic Superior Visualization Dragonfly Nose Pad Accessory Kit ( nose pad and screw) 1 pk and 20 pk
  FDA Device · Class II · 2025-09-03 · Orascoptic Surgical Acuity
• Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2186 Software Version: N/A Product Description: The NovoTHOR…
  FDA Device · Class II · 2025-09-03 · Thor Photomedicine
• AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) CYSTO, Model/Item Number ASCY24A
  FDA Device · Class II · 2025-09-03 · American Contract Systems
• L12-3 Transducer Probe
  FDA Device · Class III · 2025-09-03 · Philips Ultrasound
• C9-3io Transducer Probe
  FDA Device · Class III · 2025-09-03 · Philips Ultrasound
• X5-1 Transducer Probe
  FDA Device · Class III · 2025-09-03 · Philips Ultrasound
• S7-3t Transducer Probe
  FDA Device · Class III · 2025-09-03 · Philips Ultrasound
• OMNI II TEE Transducer Probe
  FDA Device · Class III · 2025-09-03 · Philips Ultrasound
• X3-1 Transducer Probe
  FDA Device · Class III · 2025-09-03 · Philips Ultrasound
• C6-3 Transducer Probe
  FDA Device · Class III · 2025-09-03 · Philips Ultrasound
• S8-3t Transducer Probe
  FDA Device · Class III · 2025-09-03 · Philips Ultrasound
• The Medline General Surgery Tray is customized to meet requirements of the hospitals and health care professionals utilizing them
  FDA Device · Class II · 2025-09-03 · Medline Industries Northfield
• D2TCD Transducer Probe
  FDA Device · Class III · 2025-09-03 · Philips Ultrasound
• Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon, REF: 119314
  FDA Device · Class II · 2025-09-03 · C R Bard
• STA - Fibrinogen 5. Model/Catalog Number: 00674
  FDA Device · Class II · 2025-09-03 · Diagnostica Stago
• Orascoptic Superior Visualization Dragonfly Essentials Kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdr…
  FDA Device · Class II · 2025-09-03 · Orascoptic Surgical Acuity
• C8-4v Transducer Probe
  FDA Device · Class III · 2025-09-03 · Philips Ultrasound
• mC7-2 Transducer Probe
  FDA Device · Class III · 2025-09-03 · Philips Ultrasound
• AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) A-C SUPPLEMENT PACK - 205946, Model/Item Number ANCV67X
  FDA Device · Class II · 2025-09-03 · American Contract Systems
• C9-5ec Transducer Probe
  FDA Device · Class III · 2025-09-03 · Philips Ultrasound
• Brand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04B / 68020033 Software Version: n/a Product Descr…
  FDA Device · Class II · 2025-09-03 · Dentsply Ih
• ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants
  FDA Device · Class II · 2025-09-03 · Onkos Surgical
• L10-4LAP Transducer Probe
  FDA Device · Class III · 2025-09-03 · Philips Ultrasound
• BD PhaSeal Injector Luer (N30C), REF: 515001 BD PhaSeal Injector Luer Lock (N35), REF: 515003 BD PhaSeal Injector Luer Lock (N35C), REF: 51…
  FDA Device · Class II · 2025-09-03 · Bd Switzerland Sarl
• AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) HEART PACK - 205947, MODEL/ITEM NUMBER ANCV78BC
  FDA Device · Class II · 2025-09-03 · American Contract Systems
• STA Satellite
  FDA Device · Class II · 2025-09-03 · Diagnostica Stago
• Brand Name: HOMEDICS Product Name: Air Compression Leg Massager Model/Catalog Number: SR-160HJ Product Description: Powered Inflatable Tube…
  FDA Device · Class II · 2025-09-03 · Zhejiang Luyao Electronics Technology
• L12-5 38mm Transducer Probe
  FDA Device · Class III · 2025-09-03 · Philips Ultrasound
• L11-3 Transducer Probe
  FDA Device · Class III · 2025-09-03 · Philips Ultrasound
• S5-2 Transducer Probe
  FDA Device · Class III · 2025-09-03 · Philips Ultrasound
• GE HealthCare OEC 9900 Elite C-arm Systems
  FDA Device · Class II · 2025-09-03 · Ge Medical Systems
• C5-2 Transducer Probe
  FDA Device · Class III · 2025-09-03 · Philips Ultrasound
• STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Sat…
  FDA Device · Class II · 2025-09-03 · Diagnostica Stago
• OMNI III TEE Transducer Probe
  FDA Device · Class III · 2025-09-03 · Philips Ultrasound
• X7-2t Transducer Probe
  FDA Device · Class III · 2025-09-03 · Philips Ultrasound
• mL26-8 Transducer Probe
  FDA Device · Class III · 2025-09-03 · Philips Ultrasound
• ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED 2/3 PLASMA. Canal filling stem implants
  FDA Device · Class II · 2025-09-03 · Onkos Surgical
• XL14-3 Transducer Probe
  FDA Device · Class III · 2025-09-03 · Philips Ultrasound
• X11-4t Transducer Probe
  FDA Device · Class III · 2025-09-03 · Philips Ultrasound
• C9-4v Transducer Probe
  FDA Device · Class III · 2025-09-03 · Philips Ultrasound
• AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ROBOT HYST PACK, MODEL/ITEM NUMBER GRRB10E
  FDA Device · Class II · 2025-09-03 · American Contract Systems
• Akreos, SKU: AO60P0300
  FDA Device · Class III · 2025-09-03 · Bausch And Lomb Surgical
• C8-4v Transducer Probe
  FDA Device · Class III · 2025-09-03 · Philips Ultrasound
• S3-1 Transducer Probe
  FDA Device · Class III · 2025-09-03 · Philips Ultrasound
• Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator intended to provide positive pres…
  FDA Device · Class I · 2025-08-27 · Hamilton Medical Ag
• Burr Hole Cover Kit, REF: M365DB4600C0
  FDA Device · Class II · 2025-08-27 · Boston Scientific Neuromodulation
• Pentax Medical Video Processor
  FDA Device · Class II · 2025-08-27 · Pentax
• Electrosurgical, Cutting and Coagulation and Accessories
  FDA Device · Class II · 2025-08-27 · Olympus
• ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Permanent Defibrillator Electrodes
  FDA Device · Class I · 2025-08-27 · Boston Scientific
• ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter defibrillator (non-CRT)
  FDA Device · Class I · 2025-08-27 · Boston Scientific
• Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA is an in vitro diagnostic manual medical device used by healthcare…
  FDA Device · Class II · 2025-08-27 · Immunotech A S
• Brand Name: Q-Stop Product Name: Suture Retention Device Model/Catalog Number: QS Software Version: N/A Product Description: The DRS Vascul…
  FDA Device · Class II · 2025-08-27 · Drs Vascular
• VITROS Chemistry Products Ca Slides
  FDA Device · Class II · 2025-08-27 · Ortho Clinical Diagnostics
• RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lead, Permanent Defibrillator Electrodes
  FDA Device · Class I · 2025-08-27 · Boston Scientific
• OtoLase Starter Kit
  FDA Device · Class II · 2025-08-27 · Lumenis
• Dynex Agility Sample Tips
  FDA Device · Class II · 2025-08-27 · Dynex Technologies
• Injection needle, bayonet, Luer-Lock, 1. Model no. 50-353-23, working length 25 cm, total length 31cm, nonsterile
  FDA Device · Class II · 2025-08-27 · Spiggle And Theis Mt
• Electrosurgical, Cutting and Coagulation and Accessories
  FDA Device · Class II · 2025-08-27 · Olympus
• Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived
  FDA Device · Class II · 2025-08-27 · Mckesson Medical Surgical Corporate Office
• Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/CS…
  FDA Device · Class II · 2025-08-20 · Carefree Surgical Specialties
• Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MINI 4HM/169-113, BD PYXIS MEDBANK MINI 4HH/169-112, BD PYXIS MEDB…
  FDA Device · Class III · 2025-08-20 · Carefusion 303
• DreamStation Auto CPAP. Non-Continuous Ventilator
  FDA Device · Class I · 2025-08-20 · Philips Respironics
• GE SIGNA Hero MAX (China Only), Nuclear Magnetic Resonance Imaging System
  FDA Device · Class II · 2025-08-20 · Ge Medical Systems
• GE SIGNA PET/MR AIR (China Only), Nuclear Magnetic Resonance Imaging System
  FDA Device · Class II · 2025-08-20 · Ge Medical Systems
• GE Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System
  FDA Device · Class II · 2025-08-20 · Ge Medical Systems
• Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Roll Gauze + Tail Medium 4 Long X-Ray Detectable 5pk 25…
  FDA Device · Class II · 2025-08-20 · Carefree Surgical Specialties

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)