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.
- Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509340 Software…
FDA Device · Class II · 2025-12-31 · Zimmer - Brand Name: Alcon Laboratories, Inc
FDA Device · Class I · 2025-12-31 · Alcon Research - Brand Name: Diasol Product Name: 100230-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
FDA Device · Class II · 2025-12-31 · Diasol - Brand Name: Diasol Product Name: 100125-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
FDA Device · Class II · 2025-12-31 · Diasol - BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324, BD Pyxis MedStation ES Tower, REF: 352, BD Pyxis Pro…
FDA Device · Class II · 2025-12-31 · Carefusion 303 - Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers: 1) RTPS-100
FDA Device · Class II · 2025-12-31 · Cook - Draeger Vapor 2000
FDA Device · Class I · 2025-12-31 · Draeger - KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K
FDA Device · Class II · 2025-12-31 · Microbiologics - Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509440 Software…
FDA Device · Class II · 2025-12-31 · Zimmer - The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emi…
FDA Device · Class II · 2025-12-31 · Howmedica Osteonics - Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509400 Software…
FDA Device · Class II · 2025-12-31 · Zimmer - Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
FDA Device · Class II · 2025-12-31 · Diasol - LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
FDA Device · Class II · 2025-12-31 · Icu Medical - Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509360 Software…
FDA Device · Class II · 2025-12-31 · Zimmer - Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609340 Software…
FDA Device · Class II · 2025-12-31 · Zimmer - Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509300 Software…
FDA Device · Class II · 2025-12-31 · Zimmer - LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L
FDA Device · Class II · 2025-12-31 · Microbiologics - Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609360 Software…
FDA Device · Class II · 2025-12-31 · Zimmer - Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509420 Software…
FDA Device · Class II · 2025-12-31 · Zimmer - Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
FDA Device · Class II · 2025-12-31 · Diasol - Draeger Vapor 3000
FDA Device · Class I · 2025-12-31 · Draeger - Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609320 Software…
FDA Device · Class II · 2025-12-31 · Zimmer - KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P
FDA Device · Class II · 2025-12-31 · Microbiologics - Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609400 Software…
FDA Device · Class II · 2025-12-31 · Zimmer - R¿sch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100
FDA Device · Class II · 2025-12-31 · Cook - Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0-18/38-45-RB-ANL0-HC
FDA Device · Class II · 2025-12-31 · Cook - LifeShield Drug Library Management (DLM)
FDA Device · Class II · 2025-12-31 · Icu Medical - da Vinci 5, Surgeon Console Column Motor Connector
FDA Device · Class II · 2025-12-31 · Intuitive Surgical - Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609380 Software…
FDA Device · Class II · 2025-12-31 · Zimmer - Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609300 Software…
FDA Device · Class II · 2025-12-31 · Zimmer - Brand Name: Diasol Product Name: 100220-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
FDA Device · Class II · 2025-12-31 · Diasol - BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the quantitative determination of Bica…
FDA Device · Class II · 2025-12-31 · Beckman Coulter Ireland - Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609440 Software…
FDA Device · Class II · 2025-12-31 · Zimmer - Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509380 Software…
FDA Device · Class II · 2025-12-31 · Zimmer - Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815809280 Software…
FDA Device · Class II · 2025-12-31 · Zimmer - Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
FDA Device · Class II · 2025-12-31 · Agfa Healthcare - Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609420 Software…
FDA Device · Class II · 2025-12-31 · Zimmer - Brand Name: Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
FDA Device · Class II · 2025-12-31 · Diasol - Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A CLINICIAN TABLET US…
FDA Device · Class II · 2025-12-31 · Medtronic Neuromodulation - Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509320 Software…
FDA Device · Class II · 2025-12-31 · Zimmer - Ivenix Infusion System (IIS), LVP Software LVP-SW-0005
FDA Device · Class I · 2025-12-24 · Fresenius Kabi Usa - BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener
FDA Device · Class II · 2025-12-24 · Smith And Nephew - Cardiosave Rescue
FDA Device · Class III · 2025-12-24 · Datascope - Halyard, MAJOR PACK. Catalog Number: JEMJ10-01
FDA Device · Class II · 2025-12-24 · Avid Medical - Halyard, GENERAL LAPAROSCOPY PACK. Catalog Number: VAST018-10
FDA Device · Class II · 2025-12-24 · Avid Medical - Intelerad InteleShare software, with ProViewer component
FDA Device · Class II · 2025-12-24 · Dicom Grid - Halyard, HEAD AND NECK TRAY. Catalog Number: EURO016-09
FDA Device · Class II · 2025-12-24 · Avid Medical - Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-18-SG Software Version: N/A…
FDA Device · Class II · 2025-12-24 · Rocket Medical - GE HealthCare ViewPoint 6, Catalog Number H47601AA
FDA Device · Class II · 2025-12-24 · Ge Healthcare - Zimmer Dermatome AN, Model/Catalog Number: 88710100
FDA Device · Class II · 2025-12-24 · Zimmer Surgical - FORCEP, STD STR, STERILE KELLY, 5.5 IN, Item Number DYNJ04048
FDA Device · Class II · 2025-12-24 · Medline Industries - Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10
FDA Device · Class II · 2025-12-24 · Cepheid - Brand Name: AART Pectoral Implant Product Name: Pectoral Implant Model/Catalog Number: 500-106-5 Pectoral Implant style 1 size 6 left UDI-D…
FDA Device · Class II · 2025-12-24 · Dsaart - Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF: PC2-400012
FDA Device · Class II · 2025-12-24 · Seaspine Orthopedics - Zimmer Air Dermatome, Model/Catalog Number: 00880100100
FDA Device · Class II · 2025-12-24 · Zimmer Surgical - Halyard, MIDTOWN GENERAL ARTERIOGRAM. Catalog Number: EUHM009-01
FDA Device · Class II · 2025-12-24 · Avid Medical - Brand Name: AART Malar Implant Product Name: Malar Implant Model/Catalog Number: 401-202-5 Malar Implant style 2 size 2 left UDI-DI code: B…
FDA Device · Class II · 2025-12-24 · Dsaart - Halyard, EP LAB PK. Catalog Number: ESJH009-03
FDA Device · Class II · 2025-12-24 · Avid Medical - Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10
FDA Device · Class II · 2025-12-24 · Cepheid - Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-12-PK Product Description: Ches…
FDA Device · Class II · 2025-12-24 · Rocket Medical - InPen App, Model/CFN Number: MMT-8061 (Android Users)
FDA Device · Class II · 2025-12-24 · Medtronic Minimed - GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 750 A1, REF 1012-9750-000
FDA Device · Class I · 2025-12-24 · Ge Medical Systems China - HemosIL SynthAFax
FDA Device · Class III · 2025-12-24 · Instrumentation Laboratory - 5008X CAREsystem +CLiC +CDX
FDA Device · Class II · 2025-12-24 · Fresenius Medical Care Holdings - Brand Name: AART Silicone Carving Implant Product Name: Silicone Carving Implant Model/Catalog Numbers: 600-601 - Silicone Carving Implant…
FDA Device · Class II · 2025-12-24 · Dsaart - GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S
FDA Device · Class I · 2025-12-24 · Ge Medical Systems China - Brand Name: Rocket Product Name: Rocket 20Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-20-PK Software Version: N/A Pro…
FDA Device · Class II · 2025-12-24 · Rocket Medical - Brand Name: AART Chin Implant Product Name: Chin Implant Model/Catalog Numbers: 400-0101 Chin Implant style 1 size 1 UDI-DI code: B49040010…
FDA Device · Class II · 2025-12-24 · Dsaart - Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision Distributed Monitoring System (DMS). Model…
FDA Device · Class II · 2025-12-24 · Mindray Ds Usa - Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-12-SG Software Version: N/A…
FDA Device · Class II · 2025-12-24 · Rocket Medical - MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)
FDA Device · Class II · 2025-12-24 · Path - 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer device, for WASP* *Compatible with Copan s WASP (Walk-A…
FDA Device · Class II · 2025-12-24 · Copan Italia - Brand Name: AART Gluteal Implant Product Name: Gluteal Implant Model/Catalog Numbers: 501-101 - Gluteal Implant style 1 size 1 UDI-DI code:…
FDA Device · Class II · 2025-12-24 · Dsaart - GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, REF 1012-9620-222
FDA Device · Class I · 2025-12-24 · Ge Medical Systems China - Brand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-16-PK Software Version: N/A Pro…
FDA Device · Class II · 2025-12-24 · Rocket Medical - Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20
FDA Device · Class II · 2025-12-24 · Abbott Laboratories - Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-18-PK Software Version: N/A Pro…
FDA Device · Class II · 2025-12-24 · Rocket Medical - Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF MyOSAKS2_Sb/Sc/Mb/Mc/Mp/Lb/Lc Myosa for Kids is a mouthguard in 3 different sizes…
FDA Device · Class II · 2025-12-24 · Myofunctional Research Usa - 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk
FDA Device · Class II · 2025-12-24 · Copan Italia - Brand Name: AART Calf Implant Product Name: Calf Implant Model/Catalog Number: 502-103 - Calf Implant style 1 size 3 UDI-DI code: B49050210…
FDA Device · Class II · 2025-12-24 · Dsaart - Cardiosave Hybrid
FDA Device · Class III · 2025-12-24 · Datascope - SCISSORS, OR, SHARP/BLUNT, 5.5", STERILE, Item Number DYND04000
FDA Device · Class II · 2025-12-24 · Medline Industries - Azurion R3.0. Model Number 722234
FDA Device · Class II · 2025-12-17 · Philips North America - CURAD Germ-Shield Touch-Free Fabric Bandages, Sterile, 0.75" x 3", 30/Box, Medline Item Number CUR1930F
FDA Device · Class II · 2025-12-17 · Medline Industries - Quick Strip Fabric Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number NON25650QS
FDA Device · Class II · 2025-12-17 · Medline Industries - AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description: The AMSCO 7052HP Washer/Disinfector is intended for use i…
FDA Device · Class II · 2025-12-17 · Steris - Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only
FDA Device · Class II · 2025-12-17 · Nipro Medical - Brand Name: FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer System Model/Catalog Number: 38-1007SP FORZA PTC Spacer, Straight, 0¿,…
FDA Device · Class III · 2025-12-17 · Orthofix U S - Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Ac…
FDA Device · Class II · 2025-12-17 · Beckman Coulter - MEDLINE PERFUSION SYRINGE, REF: DYNJ39223C
FDA Device · Class II · 2025-12-17 · Medline Industries - ErgoStar CM 55, Model/Catalog Number: MP01855, Airway connector for conduction of respiratory gases between the breathing system and the pa…
FDA Device · Class I · 2025-12-17 · Draeger - Stryker MV3 bariatric bed, Part Number 5900000001
FDA Device · Class II · 2025-12-17 · Stryker Medical Division - ErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for conduction of respiratory gases between the breathing system and the pa…
FDA Device · Class I · 2025-12-17 · Draeger - Brand Name: Pillar" SA PTC Spacer System Product Name: Pillar" SA PTC Spacer System Model/Catalog Number: 39-9012SP 33W X 28L X 12.5H, 7DEG…
FDA Device · Class III · 2025-12-17 · Orthofix U S - DEXLOCK Achilles Repair Implant Kits, MAKT4520
FDA Device · Class II · 2025-12-17 · Medline Industries - Quick Strip Plastic Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number NON25500QS
FDA Device · Class II · 2025-12-17 · Medline Industries - Curad Quick Strip Fabric Bandages Containing 30 Bandages of 3/4" x 3", Medline Item Number CUR1930P
FDA Device · Class II · 2025-12-17 · Medline Industries - BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630
FDA Device · Class II · 2025-12-17 · C R Bard - Brand Name: FIREBIRD" SI Fusion System Product Name: FIREBIRD" SI Fusion System Model/Catalog Number: 18-1025SP 11mm X 25mm FIREBIRD SI Scr…
FDA Device · Class III · 2025-12-17 · Orthofix U S - Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T
FDA Device · Class II · 2025-12-17 · Bard Peripheral Vascular
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)