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.
- McKesson CONSULT hCG Urine Cassette, Model/ Part: FHC-A102/5001
FDA Device · Class II · 2026-10-07 · Alere San Diego - Positron Emission Tomography and Computed Tomography System, Model: uMI 550 with software
FDA Device · Class II · 2026-10-07 · Shanghai United Imaging Healthcare - Positron Emission Tomography and Computed Tomography System, Model: uMI 780
FDA Device · Class II · 2026-10-07 · Shanghai United Imaging Healthcare - Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 8" X 2.5" 2-LINE (CS 10) Model/Catalog Number: 564001 Software Version: N…
FDA Device · Class II · 2026-10-07 · Asp Global - Evolution upgrade 1.5T amd Evolution upgrade 3.0T
FDA Device · Class II · 2026-10-07 · Philips North America - Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 24" X 4" 1-Line, Yellow Model/Catalog Number: ASP-564008 Software Version:…
FDA Device · Class II · 2026-10-07 · Asp Global - Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 1-LINE (CS 10) WHITE Model/Catalog Number: 564010 Software Versi…
FDA Device · Class II · 2026-10-07 · Asp Global - Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529, FHC-202/23900528
FDA Device · Class II · 2026-10-07 · Alere San Diego - Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 24" 2 LINE (10) Model/Catalog Number: DT-7024-02Q Software Version: Not Applicable…
FDA Device · Class II · 2026-10-07 · Asp Global - Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 44" X 4" 1-Line, Green Model/Catalog Number: ASP-564014 Software Version: N…
FDA Device · Class II · 2026-10-07 · Asp Global - HeartSine samaritan PAD (Public Access Defibrillator)
FDA Device · Class III · 2026-10-07 · Heartsine Technologies - Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 2-LINE (CS 10) WHITE Model/Catalog Number: 564011 Software Versi…
FDA Device · Class II · 2026-10-07 · Asp Global - Computed Tomography X-ray System, Model: uCT 780 with software
FDA Device · Class II · 2026-10-07 · Shanghai United Imaging Healthcare - Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo S with software
FDA Device · Class II · 2026-10-07 · Shanghai United Imaging Healthcare - Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAVH , Catalog Number: PB63VHSTC
FDA Device · Class II · 2026-10-07 · Cardinal Health 200 - Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 18" X 4" 2-LINE (CS 10) RED Model/Catalog Number: 564007 Software Version…
FDA Device · Class II · 2026-10-07 · Asp Global - VentStar Resus Neo
FDA Device · Class I · 2026-10-07 · Draeger - Computed Tomography X-ray System, Model: uCT 550 with software
FDA Device · Class II · 2026-10-07 · Shanghai United Imaging Healthcare - Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama 35 with software
FDA Device · Class II · 2026-10-07 · Shanghai United Imaging Healthcare - SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, and SmartPath to Ingenia Elition X
FDA Device · Class II · 2026-10-07 · Philips North America - Fisher Scientific Sure-Vue Urine hCG, Model/ Part: FHC-102/23900526
FDA Device · Class II · 2026-10-07 · Alere San Diego - Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 44" X 4" 2-Line, Green Model/Catalog Number: ASP-564015 Software Version: N…
FDA Device · Class II · 2026-10-07 · Asp Global - Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 30" 2 LINE (10) Model/Catalog Number: DT-7030-02Q Software Version: Not Applicable…
FDA Device · Class II · 2026-10-07 · Asp Global - Intrapulmonary Percussive Ventilation, IPV HC, Product Number: S00009
FDA Device · Class II · 2026-10-07 · Percussionaire - Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 12" X 3.5" 2-LINE (CS 12) PLUM Model/Catalog Number: A70107003 Software V…
FDA Device · Class II · 2026-10-07 · Asp Global - CHARLOTTE CLAW Screw, REF: 40122716, intended for use with CLAW II Polyaxial Compression Plating System
FDA Device · Class II · 2026-10-07 · Wright Medical Technology - Intrapulmonary Percussive Ventilation, IPV-1C, Product Number: S00002-C
FDA Device · Class II · 2026-10-07 · Percussionaire - PALACOS MV pro 40
FDA Device · Class II · 2026-10-07 · Heraeus Medical Dental Division - Computed Tomography X-ray System, Model: uCT 760 with software
FDA Device · Class II · 2026-10-07 · Shanghai United Imaging Healthcare - NovaSeq 6000Dx including DRAGEN Server, Catalog Number: 20068232
FDA Device · Class II · 2026-10-07 · Illumina - Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 44" 1 LINE (10) Model/Catalog Number: DT-7044-01Q Software Version: Not Applicable…
FDA Device · Class II · 2026-10-07 · Asp Global - EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model number: ENCPDRIVER) with soft…
FDA Device · Class II · 2026-10-07 · Bard Peripheral Vascular - Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays CARDIAC HEART BUNDLE NS Model No. LMCH99P…
FDA Device · Class II · 2026-10-07 · American Contract Systems - NOxBOXi Nitric Oxide Delivery System
FDA Device · Class II · 2026-10-07 · Noxbox - Ingenia Blue Seal SE and Blue Seal XE
FDA Device · Class II · 2026-10-07 · Philips North America - Brand Name: Ferndale Laboratories
FDA Device · Class II · 2026-10-07 · Custom Interventional Pain Management - Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector
FDA Device · Class II · 2026-09-30 · Olympus - Medline convenience kits containing Healthmark Instrument Channel Brushes
FDA Device · Class II · 2026-09-30 · Medline Industries - PRO+ 36" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide…
FDA Device · Class II · 2026-09-30 · Baxter Healthcare - PRO+ 40" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide…
FDA Device · Class II · 2026-09-30 · Baxter Healthcare - REF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 with Integrated Conserver
FDA Device · Class II · 2026-09-30 · Ventec Life Systems - nGenuity Patient Monitor with Capnography (ETCO2) CAT 8100E1-ST-US, CAT 8100E1-US, CAT 8100EP1, CAT 8100EP1-ST, CAT 8100EP1-ST-US, CAT 8100…
FDA Device · Class II · 2026-09-30 · Criticare Technologies - New York Embroidery Studio Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large
FDA Device · Class II · 2026-09-30 · New York Embroidery Studio - Brand Name: Pearle Vision 1 day Product Name: (somofilcon A) Contact Lens Model/Catalog Number: Pearle Vision 1 day
FDA Device · Class II · 2026-09-30 · Coopervision - SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, SmartPath to Ingenia Elition X
FDA Device · Class II · 2026-09-30 · Philips North America - Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5
FDA Device · Class I · 2026-09-30 · Boston Scientific - MR 7700 and Upgrade to MR 7700
FDA Device · Class II · 2026-09-30 · Philips North America - SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12
FDA Device · Class II · 2026-09-30 · Seaspine Orthopedics - Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal),…
FDA Device · Class II · 2026-09-30 · Midmark - Ingenia 3.0T and Ingenia 3.0T CX
FDA Device · Class II · 2026-09-30 · Philips North America - Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm
FDA Device · Class II · 2026-09-30 · Olympus - REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series
FDA Device · Class II · 2026-09-30 · Deroyal Industries - Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Number: M08594A Software Version: N/A Product Description: VOLARA, H…
FDA Device · Class II · 2026-09-30 · Baxter Healthcare - Ingenia Elition S and Ingenia Elition X
FDA Device · Class II · 2026-09-30 · Philips North America - Halyard IV START KIT NON-STERILE
FDA Device · Class I · 2026-09-30 · Avid Medical - Halyard IV START KIT NON-STERILE
FDA Device · Class II · 2026-09-30 · Avid Medical - Medline Convenience Kits: 1) MAJOR NEURO VCH, Catalog Number: DYNJ39218I
FDA Device · Class II · 2026-09-30 · Medline Industries - PRO+ MRS SURFACE FOR VERSACARE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves…
FDA Device · Class II · 2026-09-30 · Baxter Healthcare - Medline Convenience Kits: 1) ANTERIOR SPINE PACK, Catalog Number: DYNJT10197
FDA Device · Class II · 2026-09-30 · Medline Industries - Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal),…
FDA Device · Class II · 2026-09-30 · Midmark - INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set
FDA Device · Class I · 2026-09-30 · Coopersurgical - Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector
FDA Device · Class II · 2026-09-30 · Olympus - Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T (781295), 3. Intera 1.5T Achieva IT Nova (781175), 4. Intera 1.5T Achieva Nova…
FDA Device · Class II · 2026-09-30 · Philips North America - Achieva 3.0T
FDA Device · Class II · 2026-09-30 · Philips North America - Evolution upgrade 1.5T and Evolution upgrade 3.0T
FDA Device · Class II · 2026-09-30 · Philips North America - Medline Convenience Kits: 1) PEDS SINUS PACK, Catalog Number: DYNJ02516G
FDA Device · Class II · 2026-09-30 · Medline Industries - Achieva XR
FDA Device · Class II · 2026-09-30 · Philips North America - INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set
FDA Device · Class I · 2026-09-30 · Coopersurgical - Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S
FDA Device · Class II · 2026-09-30 · Philips North America - REF: HF2POSTD HomeFill Oxygen System HomeFill cylinder D with CGA870 Compatible Post Valve
FDA Device · Class II · 2026-09-30 · Ventec Life Systems - CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors
FDA Device · Class II · 2026-09-30 · Fresenius Medical Care Renal Therapies Group - Medline Convenience Kits: 1) MFC CRANIOTOMY PACK, Catalog Number: DYNJT8784
FDA Device · Class II · 2026-09-30 · Medline Industries - Medline convenience kits containing Healthmark Instrument Channel Brushes
FDA Device · Class II · 2026-09-30 · Medline Industries - ForeSight Elite Tissue Oximetry Cable REF HEMFSM10 UDI-DI code: 00690103210927 The non-invasive ForeSight oximeter cable is intended for us…
FDA Device · Class II · 2026-09-30 · Becton Dickinson And - Halyard IV START KIT NON-STERILE
FDA Device · Class II · 2026-09-30 · Avid Medical - Medline Convenience Kits: 1) MAJOR PACK, Catalog Number: DYNJ81325A
FDA Device · Class II · 2026-09-30 · Medline Industries - Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector
FDA Device · Class II · 2026-09-30 · Olympus - Presource Convenience Kits: 1) KIT, PRE OP , Catalog Number: AMN548616A
FDA Device · Class II · 2026-09-30 · Cardinal Health 200 - Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system
FDA Device · Class II · 2026-09-30 · Philips North America - Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector
FDA Device · Class II · 2026-09-30 · Olympus - Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA
FDA Device · Class II · 2026-09-30 · Abiomed - Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal),…
FDA Device · Class II · 2026-09-30 · Midmark - MR 5300 Model Number (REF): 1. 782110, 2. 782152
FDA Device · Class II · 2026-09-30 · Philips North America - Presource Convenience Kits: 1) KIT, USGPIV , Catalog Number: PVMHIVMHD
FDA Device · Class II · 2026-09-30 · Cardinal Health 200 - Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234
FDA Device · Class II · 2026-09-30 · Philips Ultrasound - VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811
FDA Device · Class II · 2026-09-30 · Biomerieux - Cardioroot Woven Collagen Coated Vascular Graft
FDA Device · Class II · 2026-09-30 · Intervascular Sas - PowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-100nm) Model Numbers: 1. ARD568474114A, 2. ARD567501286
FDA Device · Class II · 2026-09-30 · Maquet Sas - Ingenia Ambition S and Ingenia Ambition X
FDA Device · Class II · 2026-09-30 · Philips North America - Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module Model/Catalog Number: S3610, S2610, S2000, S1610 multimod…
FDA Device · Class II · 2026-09-30 · Heidelberg Engineering - Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal),…
FDA Device · Class II · 2026-09-30 · Midmark - HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870 Compatible Post Valve
FDA Device · Class II · 2026-09-30 · Ventec Life Systems - Reign Medical Clench Staple System (Compression), Description/REF: 9mm x 7mm/152-30907
FDA Device · Class II · 2026-09-23 · F And A Foundation - Convenience kits MYRINGOTOMY PACK-LF DYNJ59097A
FDA Device · Class II · 2026-09-23 · Medline Industries - IV Sets with drip chambers
FDA Device · Class II · 2026-09-23 · Icu Medical - Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000
FDA Device · Class II · 2026-09-23 · Datex Ohmeda - Medline Convenience Kits: 1) DYNDH1193, Catalog Number: DYNDH1193
FDA Device · Class I · 2026-09-23 · Medline Industries - Medline Convenience Kits: 1) DYNDB3086D, Catalog Number: DYNDB3086D
FDA Device · Class I · 2026-09-23 · Medline Industries - Haylard CONTINUOUS NERVE BLOCK TRAY
FDA Device · Class I · 2026-09-23 · Avid Medical - Convenience kits ANESTHESIA PAIN PK LEAGUE DYNJ67925A
FDA Device · Class II · 2026-09-23 · Medline Industries
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)